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Early experience of COVID-19 vaccination in adults with systemic rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance Vaccine Survey

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Background We describe the early experiences of adults with systemic rheumatic disease who received the COVID-19 vaccine. Methods From 2 April to 30 April 2021, we conducted an online, international survey of adults with systemic rheumatic disease who received COVID-19 vaccination. We collected patient-reported data on clinician communication, beliefs and intent about discontinuing disease-modifying antirheumatic drugs (DMARDs) around the time of vaccination, and patient-reported adverse events after vaccination. Results We analysed 2860 adults with systemic rheumatic diseases who received COVID-19 vaccination (mean age 55.3 years, 86.7% female, 86.3% white). Types of COVID-19 vaccines were Pfizer-BioNTech (53.2%), Oxford/AstraZeneca (22.6%), Moderna (21.3%), Janssen/Johnson & Johnson (1.7%) and others (1.2%). The most common rheumatic disease was rheumatoid arthritis (42.3%), and 81.2% of respondents were on a DMARD. The majority (81.9%) reported communicating with clinicians about vaccination. Most (66.9%) were willing to temporarily discontinue DMARDs to improve vaccine efficacy, although many (44.3%) were concerned about rheumatic disease flares. After vaccination, the most reported patient-reported adverse events were fatigue/somnolence (33.4%), headache (27.7%), muscle/joint pains (22.8%) and fever/chills (19.9%). Rheumatic disease flares that required medication changes occurred in 4.6%. Conclusion Among adults with systemic rheumatic disease who received COVID-19 vaccination, patient-reported adverse events were typical of those reported in the general population. Most patients were willing to temporarily discontinue DMARDs to improve vaccine efficacy. The relatively low frequency of rheumatic disease flare requiring medications was reassuring.
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Sattui SE, etal. RMD Open 2021;7:e001814. doi:10.1136/rmdopen-2021-001814
ORIGINAL RESEARCH
Early experience of COVID-19
vaccination in adults with systemic
rheumatic diseases: results from the
COVID-19 Global Rheumatology
Alliance Vaccine Survey
Sebastian Eduardo Sattui ,1 Jean W Liew,2 Kevin Kennedy ,3
Emily Sirotich ,4 Michael Putman,5 Tarin T Moni,6 Akpabio Akpabio ,7
Deshiré Alpízar- Rodríguez ,8 Francis Berenbaum ,9 Inita Bulina,10
Richard Conway ,11 Aman Dev Singh,12 Eimear Duff,13 Karen L Durrant,14
Tamer A Gheita,15 Catherine L Hill,16,17 Richard A Howard,18 Bimba F Hoyer,19
Evelyn Hsieh,20,21 Lina El Kibbi,22 Adam Kilian,23 Alfred Hyoungju Kim ,24
David F L Liew,25,26 Chieh Lo,27 Bruce Miller,28 Serena Mingolla,29 Michal Nudel,30
Candace A Palmerlee,31 Jasvinder A Singh ,32,33 Namrata Singh,34
Manuel Francisco Ugarte- Gil ,35,36 John Wallace,37 Kristen J Young,38
Suleman Bhana,39 Wendy Costello,40 Rebecca Grainger,41
Pedro M Machado ,42,43 Philip C Robinson ,44,45 Paul Sufka,46
Zachary S Wallace,47,48 Jinoos Yazdany,49 Carly Harrison,50 Maggie Larché,51
Mitchell Levine,52 Gary Foster,53 Lehana Thabane,52 Lisa G Rider,54
Jonathan S Hausmann ,48,55,56 Julia F Simard ,57,58 Jeffrey A Sparks 48,59
To cite: SattuiSE, LiewJW,
KennedyK, etal. Early
experience of COVID-19
vaccination in adults with
systemic rheumatic diseases:
results from the COVID-19
Global Rheumatology Alliance
Vaccine Survey. RMD Open
2021;7:e001814. doi:10.1136/
rmdopen-2021-001814
Additional supplemental
material is published online only.
To view, please visit the journal
online (http:// dx. doi. org/ 10.
1136/ rmdopen- 2021- 001814).
JSH, JFS and JAS contributed
equally.
SES and JWL contributed
equally.
SES and JWL are joint rst
authors.
JSH, JFS and JAS are joint
senior authors.
Received 9 July 2021
Accepted 18 August 2021
For numbered afliations see
end of article.
Correspondence to
Dr Jeffrey A Sparks;
jsparks@ bwh. harvard. edu
Infections
© Author(s) (or their
employer(s)) 2021. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published
by BMJ.
ABSTRACT
Background We describe the early experiences of
adults with systemic rheumatic disease who received the
COVID-19 vaccine.
Methods From 2 April to 30 April 2021, we conducted
an online, international survey of adults with systemic
rheumatic disease who received COVID-19 vaccination.
We collected patient- reported data on clinician
communication, beliefs and intent about discontinuing
disease- modifying antirheumatic drugs (DMARDs) around
the time of vaccination, and patient- reported adverse
events after vaccination.
Results We analysed 2860 adults with systemic
rheumatic diseases who received COVID-19 vaccination
(mean age 55.3 years, 86.7% female, 86.3% white). Types
of COVID-19 vaccines were Pzer- BioNTech (53.2%),
Oxford/AstraZeneca (22.6%), Moderna (21.3%), Janssen/
Johnson & Johnson (1.7%) and others (1.2%). The most
common rheumatic disease was rheumatoid arthritis
(42.3%), and 81.2% of respondents were on a DMARD.
The majority (81.9%) reported communicating with
clinicians about vaccination. Most (66.9%) were willing
to temporarily discontinue DMARDs to improve vaccine
efcacy, although many (44.3%) were concerned about
rheumatic disease ares. After vaccination, the most
reported patient- reported adverse events were fatigue/
somnolence (33.4%), headache (27.7%), muscle/joint
Key messages
What is already known about this subject?
People with systemic rheumatic diseases, who
were largely excluded from COVID-19 vaccine
clinical trials, may have additional concerns
about the impact of their underlying disease or
antirheumatic medications on COVID-19 vaccine
response.
Studies of rheumatic disease flares following
vaccination for other infections were previously
reassuring, and studies from a physician- based
registry and a prospective cohort have shown
a low frequency of flares following COVID-19
vaccination.
What does this study add?
In this international online survey of adults
with systemic rheumatic disease who received
COVID-19 vaccination, patient- reported adverse
events were typical of those reported in the gen-
eral population, with rheumatic disease flare re-
quiring medication changes occurring in <5%.
Most patients were willing to temporarily discon-
tinue disease- modifying antirheumatic drugs in
order to improve vaccine efficacy.
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pains (22.8%) and fever/chills (19.9%). Rheumatic disease ares that
required medication changes occurred in 4.6%.
Conclusion Among adults with systemic rheumatic disease who
received COVID-19 vaccination, patient- reported adverse events were
typical of those reported in the general population. Most patients were
willing to temporarily discontinue DMARDs to improve vaccine efcacy.
The relatively low frequency of rheumatic disease are requiring
medications was reassuring.
INTRODUCTION
Multiple COVID-19 vaccines have become available, with
established safety and efficacy in the general population.1
However, people with systemic rheumatic diseases, who
may have a unique risk and benefit profile, were largely
excluded from the initial vaccine clinical trials. People
with systemic rheumatic diseases may have specific
concerns on how their underlying disease or their immu-
nomodulatory therapies affect the benefit and safety of
receiving COVID-19 vaccination.2 3 These concerns have
been further complicated by heterogenous vaccine roll-
outs and access, and conflicting advice from clinicians
in response to major organisation recommendations.4–6
There is a paucity of data regarding vaccinated patients
with rheumatic diseases, and better information could
inform decision making and guidance for clinicians
and patients. This study describes a large, international
survey of adults with systemic rheumatic disease who
received a COVID-19 vaccine, focusing on their experi-
ences communicating with clinicians, their beliefs about
and management of medications for their rheumatic
disease around the time of vaccination, and their experi-
ence with adverse events after vaccination.
METHODS
Survey design and inclusion
The COVID-19 Global Rheumatology Alliance (C19- GRA)
Vaccine Survey was developed and refined based on feed-
back from relevant stakeholders (clinicians, researchers
and patient partners) and collaborators from December
2020 through March 2021. The survey collected informa-
tion from both COVID-19 vaccinated and unvaccinated
adults with systemic rheumatic diseases.
To study a more homogenous group and to obtain a
better understanding of characteristics and factors asso-
ciated with vaccination, this analysis was restricted to
adults with systemic rheumatic diseases who received
COVID-19 vaccination. Respondents were included if
they completed the survey in English, Italian or Hebrew
(first translations made available) between 2 April and 30
April 2021 and reported having received at least one dose
of any COVID-19 vaccine. Respondents were excluded if
they did not provide information on the following char-
acteristics: age, sex, country of residence, race/ethnicity,
rheumatic disease diagnosis and use of antirheumatic
medications. Respondents reporting only diagnoses of
osteoarthritis and/or only fibromyalgia without other
systemic rheumatic diseases were also excluded.
The survey was administered online using the Qualtrics
platform, an online survey software that allows for the
creation and distribution of surveys and other measure-
ment tools. After providing initial consent to partici-
pate, respondents were required to enter their year of
birth and only received additional questions if they were
over the age of 18 years. Where possible, participants
were required to enter a response to questions before
proceeding in order to minimise missing responses. Also,
Internet Protocol address gating, restricting only one
survey entry per individual (or source), was employed in
order to secure integrity of responses and data.
Measures and data collection
Demographics
Self- reported demographics including year of birth
(from which age was calculated), sex assigned at birth,
highest level of education, current employment and
country of residence were collected. Country of resi-
dence was grouped by the WHO region.7 Race/Ethnicity
was grouped into mutually exclusive categories: black,
Asian (including East Asian, South Asian and West
Asian), Hispanic, Latinx or Latin American, white, Amer-
ican Indian/Alaska Natives/Aboriginal/Indigenous/
First Nations, Arab, Pacific Islander and multiple iden-
tities (ie, participants reporting more than one race/
ethnicity).
Systemic rheumatic disease diagnosis and clinical information
Participants could report multiple systemic rheumatic
disease diagnoses. Comorbidities were also collected
and included over 30 possible selections. Patient global
assessment of current rheumatic disease activity was self-
reported using a patient global assessment of disease
activity visual analogue scale from 0 (remission/very low
disease activity) to 10 (very high disease activity).8
Disease-modifying antirheumatic drug, glucocorticoid and non-
steroidal anti-inammatory drug use
Participants reported the disease- modifying antirheu-
matic drugs (DMARDs), glucocorticoids and non-
steroidal anti- inflammatory drugs (NSAIDs) that they
were taking at the time of the survey. Medications were
grouped into different classes according to mechanism
of action, with a free text option to report additional
medications. Free text was categorised into appropriate
medication classes after translation.
Key messages
How might this impact on clinical practice or further
developments?
Clinicians should maintain awareness of changing guidelines as
further data become available in order to provide continued com-
munication and patient counselling regarding risks and benets of
vaccination.
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InfectionsInfectionsInfections
DMARDs were categorised using the most recent
American College of Rheumatology (ACR) COVID-19
Vaccine Clinical Guidance Summary.6 Medications,
where holding or altered dosage timing around time of
vaccination was recommended (methotrexate, abatacept,
rituximab, Janus kinase (JAK) inhibitors) were grouped
independently.
Communication with clinicians and medication changes
Participants were asked about vaccine- related commu-
nication and counselling by their clinicians. All survey
respondents were asked about their general willing-
ness to temporarily discontinue medications based on a
5- point Likert scale. In addition, for each specific medi-
cation that participants reported taking, they were asked
if they would be willing to discontinue those medica-
tions (yes/no/unsure), to improve the effectiveness of
a COVID-19 vaccine. They were also asked about their
greatest concern(s) about temporarily discontinuing
those medications. Finally, participants were asked if they
held any medications before or after vaccination (yes/
no/unsure).
Adverse events after vaccination
In addition to self- reported anaphylaxis, participants were
asked about the occurrence of postvaccination adverse
events, lasting >2 days and within 2 months of vaccination,
such as headaches, fever or chills, widespread muscle/
joint pain and rash, among others. Respondents also
reported whether they experienced postvaccine flares of
existing systemic rheumatic disease (lasting >2 days) and
if these flares required treatment modifications.
Survey dissemination
The English language version of the survey was launched
globally on 2 April 2021. Translations in Italian and
Hebrew were added on 5 April 2021. We employed a
convenience sampling strategy with patient partners
leading survey dissemination. International patient
organisations received images, text and survey links
designed to explain the survey’s purpose, and dissem-
inated the survey to their members. Additionally, the
survey was publicly accessible from the C19- GRA website (
www. rheum- covid. org) and disseminated via social media
by GRA members and patient organisations. The full
survey is included in the online supplemental materials.
Statistical analysis
Descriptive statistics, including means and SD, propor-
tions and 95% CIs, were reported. All analyses were
performed using R V.4.1.0.
RESULTS
Demographics and clinical characteristics
Between 2 April and 30 April 2021, 2860 adults with
systemic rheumatic disease who received at least one
dose of a COVID-19 vaccine participated in the survey
(see figure 1 for flow diagram of analysed sample). The
mean (SD) age of participants was 55.3 (14.3) years, 2480
(86.7%) were female and 2469 (86.3%) self- identified
as white. Most participants (1603, 56.1%) were from
the Americas (USA n=1366, Canada n=200 and Latin
America n=37), followed by respondents from the Euro-
pean region (UK n=935, and rest of Europe n=252).
Demographics and clinical characteristics of respondents
are shown in table 1.
Rheumatoid arthritis (RA) (1209, 42.3%) was the most
common systemic rheumatic disease reported among
participants, followed by inflammatory myositis (487,
17.0%), Sjögren’s syndrome (438, 15.3%), systemic
lupus erythematosus (391, 13.7%) and spondyloarthritis
(256, 9.0%). Use of systemic glucocorticoids and NSAIDs
was reported by 762 (26.6%) and 740 (25.9%), respec-
tively. The most used DMARDs were methotrexate (855,
29.9%), antimalarials (733, 25.6%) and other conven-
tional synthetic DMARDs (510, 17.8%). Tumour necrosis
factor (TNF) inhibitors were the most used biologic
DMARD (bDMARD) (493, 17.2%), and 520 (18.2%) of
patients reported not taking any DMARD.
The most reported comorbidities were hypertension
(912, 31.9%), lung disease (736, 25.7%) and obesity
(673, 23.5%). The most received COVID-19 vaccine was
the Pfizer- BioNTech vaccine (1522, 53.2%), followed
by Oxford- AstraZeneca (645, 22.6%), Moderna (610,
21.3%) and Janssen/Johnson & Johnson (50, 1.7%). Few
respondents received other vaccines (33, 1.2%).
Communication with healthcare providers regarding
COVID-19 vaccination
Most participants (2341, 81.9%) had discussed COVID-19
vaccination with their healthcare provider. Participants
Figure 1 Flow diagram illustrating the analysed sample.
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Table 1 Demographics and clinical characteristics of
the COVID-19 Global Rheumatology Vaccine Survey
respondents who received COVID-19 vaccination (n=2860)
Number of
respondents N (%)
Age (years), mean (SD) 55.3 (14.3)
Age (years) categories
18–29 139 (4.9)
30–49 788 (27.6)
50–69 1336 (46.7)
70+ 469 (16.4)
Sex at birth
Female 2480 (86.7)
Male 373 (13.0)
Other/Prefer not to say 7 (0.2)
Race/Ethnicity
White 2469 (86.3)
Hispanic, Latinx or Latin American 77 (2.7)
Asian (South, East Asian) 46 (1.6)
Black 37 (1.3)
Middle Eastern or North African 21 (0.7)
American Indian/laska Natives/Aboriginal/
Indigenous/First Nations
7 (0.2)
Other* 203 (7.1)
WHO region
Region of the Americas 1603 (56.1)
European region 1187 (41.5)
Western Pacic/South- East Asian/African/
Eastern Mediterranean regions
70 (2.4)
Educational level
High school (secondary level)/General
Educational Development (GED) or less
314 (11.0)
Some college 553 (19.3)
Bachelor’s degree (graduated college) 776 (27.1)
Graduate or professional degree 1217 (42.6)
Systemic rheumatic disease diagnosis†
Rheumatoid arthritis 1209 (42.3)
Inammatory myositis 487 (17.0)
Sjögren’s syndrome 438 (15.3)
Systemic lupus erythematosus 391 (13.7)
Spondyloarthritis, other than psoriatic arthritis 256 (9.0)
Psoriatic arthritis 206 (7.2)
Other connective tissue disease‡ 196 (6.9)
Systemic vasculitis 167 (5.8)
Systemic sclerosis 126 (4.4)
Antiphospholipid syndrome 68 (2.4)
Autoinammatory disease 31 (1.1)
Sarcoidosis 21 (0.7)
Medications†
Systemic glucocorticoids 762 (26.6)
NSAIDs 740 (25.9)
DMARDs
Continued
Number of
respondents N (%)
Antimalarials 733 (25.6)
Methotrexate 855 (29.9)
Other csDMARDs§ 513 (17.8)
Mycophenolate mofetil 228 (8.0)
Other antimetabolites¶ 21 (0.7)
Abatacept 71 (2.5)
Rituximab 162 (5.7)
TNF inhibitors 498 (17.2)
Other bDMARDs** 206 (7.2)
JAK inhibitors 121 (4.2)
IVIG 102 (3.6)
Number of DMARDs
0 520 (18.2)
1 1271 (44.4)
2 839 (29.3)
3 or more 230 (8.0)
Patient global assessment of disease activity
(0=very low; 10=very high)
Mean (SD) 4.2 (2.4)
Comorbidities
Hypertension 912 (31.9)
Lung disease†† 736 (25.7)
Obesity 672 (23.5)
Diabetes 164 (5.7)
Cardiovascular disease 163 (5.7)
None 832 (29.1)
COVID-19 vaccine received
Pzer- BioNTech 1522 (53.2)
Oxford- AstraZeneca 645 (22.6)
Moderna 610 (21.3)
Janssen/Johnson & Johnson 50 (1.7)
Other vaccines‡‡ 33 (1.2)
*Other participants include Pacic Islander, other, prefer not to say and do
not know/unsure.
†Participants may indicate more than one rheumatic disease and more
than one antirheumatic medication.
‡Other connective tissue disease include mixed connective tissue disease
and undifferentiated connective tissue disease.
§Includes apremilast, azathioprine, 6- mercaptopurine, leunomide,
sulfasalazine.
¶Includes calcineurin inhibitors (ciclosporin, tacrolimus),
cyclophosphamide, thalidomide and lenalidomide.
**Includes asthma, emphysema, chronic bronchitis, chronic obstructive
pulmonary disease, pulmonary hypertension, interstitial lung disease,
idiopathic pulmonary brosis, other lung diseases.
††Includes belimumab, IL-1 inhibitors (anakinra, canakinumab, rilonacept),
IL-6 inhibitors (tocilizumab, sarilumab, siltuximab), IL-12/IL-23 inhibitors
(ustekinumab, guselkumab), IL-17 inhibitors (secukinumab, ixekizumab),
eculizumab, mepolizumab and vedolizumab.
‡‡Includes Novavax, Sinovac/Sinopharm, Sputnik V, Cansino, ‘not sure’
and ‘other’.
bDMARDs, biologic DMARDs; csDMARDs, conventional synthetic
DMARDs; DMARDs, drug- modifying antirheumatic drugs; IL, interleukin;
IVIG, intravenous immunoglobulin; JAK, Janus kinase inhibitors; NSAIDs,
non- steroidal anti- inammatory drugs; TNF, tumour necrosis factor.
Table 1 Continued
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reported contacting their healthcare provider to discuss
COVID-19 vaccination (1775, 62.1%), having the health-
care provider contact them (1349, 47.2%) and/or having
a discussion regarding vaccines during a clinical visit
(1817, 63.5%) (table 2). Of all respondents who discussed
vaccination with their healthcare provider, 2238/2341
(95.6%) reported that vaccination was recommended,
while 42 (1.8%) answered that their provider was unsure,
and 10 (0.4%) reported a provider recommendation
against vaccination. Most patients (2065, 88.2%) were
satisfied with the conversation with their clinician, while
only a minority were dissatisfied (66, 2.8%) or neither
satisfied nor dissatisfied (210, 9.0%).
Medications and COVID-19 vaccination
Most participants (1911, 66.8%) agreed with tempo-
rarily discontinuing their medications to improve
vaccine effectiveness, while 472 (16.5%) disagreed and
477 (16.7%) reported being unsure. Concern for flare
of systemic rheumatic disease after receiving the vaccine
was reported in 1267 (44.3%) respondents, while 1009
(35.3%) were not concerned, and 584 (20.4%) were
unsure.
When asked about the specific medications that partic-
ipants reported taking for the treatment of their systemic
rheumatic disease, the majority were willing to discon-
tinue these medications due to COVID-19 vaccination
(figure 2; online supplemental table). For participants
taking methotrexate, 700/855 (81.9%) were willing to
stop, with only 59 (6.9%) not willing to stop. For other
medications recommended by the ACR to be modified
around COVID-19 vaccination (eg, NSAIDs, mycopheno-
late, abatacept, rituximab, JAK inhibitors), the majority
of respondents were willing to discontinue temporarily.
Among participants taking systemic glucocorticoids,
fewer (375/762, 49.2%) were willing to stop, 246 (32.3%)
were not willing to stop and 141 (18.5%) were unsure.
Finally, when asked about actual medication discontin-
uation, most patients who reported taking any prescrip-
tion medication (1875/2644, 70.9%) answered that they
did not temporarily stop or discontinue any of their
rheumatic medications before or after receiving the
COVID-19 vaccine, while a minority decided to change
their medication use (764, 28.9%). Only five (0.2%)
patients were not sure if they had made any changes to
their medication use.
Systemic rheumatic disease flare was the most frequently
reported concern regarding holding or stopping
Figure 2 Willingness to temporarily or permanently
discontinue medications when receiving the COVID-19
vaccine. IL, interleukin; NSAIDs, non- steroidal anti-
inammatory drugs; csDMARDs, conventional synthetic
drug modifying antirheumatic drugs; JAK, Janus kinase
inhibitors; TNF, tumour necrosis factor; IVIG, intravenous
immunoglobulin. *Includes apremilast, azathioprine,
6- mercaptopurine, leunomide and sulfasalazine.
†Includes calcineurin inhibitors (ciclosporin, tacrolimus),
cyclophosphamide, thalidomide and lenalidomide.
‡Includes belimumab, IL-1 inhibitors (anakinra,
canakimumab, rilonacept), IL-6 inhibitors (tocilizumab,
sarilumab, siltuximab), IL-12/IL-23 inhibitors (ustekinumab,
guselkumab), IL-17 inhibitors (secukinumab, ixekizumab),
eculizumab, mepolizumab and vedolizumab.
Table 2 Communication with healthcare providers
regarding COVID-19 vaccination
Number of
respondents
N (%)
Contacted healthcare provider to discuss
vaccine
N=2860
Ye s 1775 (62.1)
No 965 (33.7)
Not sure/Not applicable 120 (4.2)
Contact from healthcare provider to
discuss vaccine
N=2860
Ye s 1349 (47.2)
No 1383 (48.4)
Not sure/Not applicable 128 (4.5)
Discussed vaccine with healthcare provider
during a visit
N=2860
Ye s 1817 (63.5)
No 932 (32.6)
Not sure/Not applicable 111 (3.9)
Advice from healthcare provider about
receiving COVID-19 vaccine
N=2341
Strongly endorsed 1938 (82.8)
Suggested it 300 (12.8)
Provider was unsure 42 (1.8)
Advised against it 6 (0.3)
Strongly discouraged 4 (0.2)
Respondent unsure/Missing 51 (2.2)
Satisfaction about COVID-19 vaccine
conversation with healthcare provider
N=2341
Very satised 1491 (63.7)
Satised 574 (24.5)
Neither satised nor dissatised 210 (9.0)
Dissatised 52 (2.2)
Very dissatised 14 (0.6)
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antirheumatic medications (table 3). In participants taking
systemic glucocorticoids, disease flares were the most
frequently reported concern (443/762, 58.1%) followed by
withdrawal effects (188, 24.7%). Disease flare was the most
common concern among patients on all other medications.
‘No concerns’ was the second most frequent response for
people receiving all other medications, except for TNF
inhibitors and other bDMARDs where ‘concern for rheu-
matic medication may not work as well’ (73/494, 14.8% and
21/206, 10.2%, respectively) was reported.
COVID-19 vaccination-associated adverse events
Among all participants, 1371/2860 (47.9%) participants
reported at least one adverse event lasting for at least 2
days post- COVID-19 vaccine (table 4). Fatigue or sleepi-
ness (955, 33.4%) was the most common reported adverse
event, followed by headache (792, 27.7%), and wide-
spread muscle/joint pains (653, 22.8%). There were only
six (0.2%) episodes of self- reported anaphylaxis. Flares of
existing systemic rheumatic disease, lasting at least 2 days
post- COVID-19 vaccine, were reported by 382 (13.4%) of
participants, with 132 (4.6%) requiring a new or increased
dose of medication to treat the flare. The frequency of
adverse events and flares of disease were similar across
vaccine types.
DISCUSSION
This is the largest international survey of patient percep-
tions and outcomes related to COVID-19 vaccines among
vaccinated people with systemic rheumatic diseases.
Almost all participants who discussed vaccination with
a provider were recommended to receive a COVID-19
vaccination and respondents were overall satisfied with
COVID-19 vaccine- related conversations with their clini-
cians. The majority were willing to discontinue their
medications to improve vaccine response, although
many remained concerned about systemic rheumatic
disease flares. Although 1 in 8 reported a flare of disease
after vaccination, fewer than 1 in 20 required a change
in treatment. While these findings have been reassuring
regarding communication with physicians regarding
vaccination recommendations, individuals with systemic
rheumatic disease remain concerned about the side
effects of vaccines, and the risk of flares associated with
vaccination, particularly around holding antirheumatic
medications.
People with systemic rheumatic disease represent a
subgroup for whom general population data may not
apply. Potential concerns include reduced immunoge-
nicity of vaccines related to either the underlying condi-
tion or the use of antirheumatic medications; and vaccines
causing worsened adverse events or flares of their under-
lying rheumatic diseases.2 In an international survey of
1531 individuals with rheumatic disease conducted in
December 2020, for instance, 32% reported uncertainty
around vaccination,3 which may in part be driven by
these concerns.
Table 3 Concerns about medication discontinuation around COVID-19 vaccination
N
Disease
are
Withdrawal
effects
Side effects
when previously
stopped
Unsuccessful
when previously
stopped
Medication may
no longer work
as well
No
concerns
Systemic
glucocorticoids
762 443 (58.1) 188 (24.7) 26 (3.4) 28 (3.7) 15 (2.0) 62 (8.1)
NSAIDs 740 412 (55.7) 18 (2.4) 29 (3.9) 13 (1.8) 14 (1.9) 254 (34.3)
Antimalarials 733 518 (70.7) 24 (3.3) 8 (1.1) 8 (1.1) 18 (2.5) 157 (21.4)
Methotrexate 855 616 (72.0) 13 (1.5) 10 (1.2) 3 (0.4) 39 (4.6) 174 (20.4)
Other csDMARDs* 513 372 (72.5) 13 (2.5) 6 (1.2) 8 (1.6) 19 (3.7) 95 (18.5)
Mycophenolate 228 169 (74.8) 8 (3.5) 9 (4.0) 2 (0.9) 7 (3.1) 33 (14.6)
Other
antimetabolites†
21 11 (52.4) 1 (4.8) 1 (4.8) 0 (0) 1 (4.8) 7 (33.3)
Abatacept 71 53 (74.6) 3 (4.2) 1 (1.4) 0 (0) 5 (7.0) 9 (12.7)
Rituximab 162 131 (81.9) 1 (0.6) 3 (1.9) 2 (1.3) 7 (4.4) 18 (11.3)
TNF inhibitors 493 369 (75.5) 6 (1.2) 5 (1.0) 4 (0.8) 73 (14.8) 36 (7.4)
Other biologics‡ 206 157 (77.3) 4 (2.0) 2 (1.0) 3 (1.5) 21 (10.2) 19 (9.4)
JAK inhibitors 121 104 (86.0) 2 (1.7) 1 (0.8) 0 (0) 7 (5.8) 7 (5.8)
IVIG 102 80 (79.2) 2 (2.0) 1 (1.0) 1 (1.0) 1 (1.0) 17 (16.8)
*Includes apremilast, azathioprine, 6- mercaptopurine, leunomide, sulfasalazine.
†Includes calcineurin inhibitors (ciclosporin, tacrolimus), cyclophosphamide, thalidomide and lenalidomide.
‡Includes belimumab, IL-1 inhibitors (anakinra, canakimumab, rilonacept), IL-6 inhibitors (tocilizumab, sarilumab, siltuximab), IL-12/IL-23
inhibitors (ustekinumab, guselkumab), IL-17 inhibitors (secukinumab, ixekizumab), eculizumab, mepolizumab and vedolizumab.
csDMARDs, conventional synthetic DMARDs; DMARDs, drug- modifying antirheumatic drugs; IL, interleukin; IVIG, intravenous
immunoglobulin; JAK, Janus kinase inhibitors; NSAIDs, non- steroidal anti- inammatory drugs; TNF, tumour necrosis factor.
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InfectionsInfectionsInfections
Rheumatologists have a prominent role in commu-
nicating risks and benefits of vaccination. Prior surveys
of people with systemic rheumatic diseases have high-
lighted limited communication with rheumatologists or
other healthcare providers, especially about medication
changes.9–11 Other studies have cited lack of a recom-
mendation from a treating physician for vaccination
hesitancy.12–15 Among the vaccinated population in our
study, there was a high frequency of communication with
clinicians about the COVID-19 vaccines, and respondents
were generally very satisfied. A key factor is the timing of
our survey during global vaccination efforts versus other
surveys that were completed prior to the availability of
the COVID-19 vaccine. Another factor is that our study
sample was limited to those who were vaccinated, so good
communication with healthcare providers over vaccine
recommendations is unsurprising.
Whether to hold antirheumatic medications for vacci-
nation, and for how long, remains unclear for many
medication classes. Hypothetical concerns about reduced
immunogenicity have recently been corroborated by
antibody titre studies.16 17 Recommendations from the
ACR, for instance, have reflected these concerns. Initial
guidance in February of 2021 recommended holding
methotrexate, JAK inhibitors, abatacept and rituximab in
certain patients with controlled disease6; an April 2021
update also included mycophenolate mofetil.18 These
guidelines were based on limited data, including one
randomised controlled trial of methotrexate holding
for influenza vaccination in patients with RA,19 and
two studies of holding tofacitinib in patients with RA.20
Our survey found that most patients would be willing
to temporarily discontinue their medications but had
concerns about a flare of their systemic rheumatic
disease. As expected, current glucocorticoid users had an
especially high frequency of respondents who were less
willing to hold these medications. This may be explained
by prior experience of flares when stopping or lowering
dose of glucocorticoids, concerns about adrenal insuffi-
ciency or a relationship between glucocorticoid use and
active disease. However, despite reported willingness,
only a minority of participants discontinued any medi-
cation around COVID-19 vaccination. Future studies
are needed to firmly establish an evidence base for
temporarily holding specific antirheumatic therapies to
enhance vaccine efficacy while balancing risk for disease
flare.
The degree to which vaccination in general and the
COVID-19 vaccinations in particular cause flares of rheu-
matic diseases has been a principal concern.21 Prior to the
COVID-19 pandemic, a study in the UK Clinical Practice
Research Database found no increased risk of flare after
influenza vaccination among people with autoimmune
inflammatory rheumatic disease.22 In a small study, RA
disease activity remained stable following hepatitis B vacci-
nation.23 Conversely, an internet- based case- crossover
study of patients with confirmed gout found twofold
higher odds for gout flares after any patient- reported
vaccination.24 Similar to the rates reported in trials in
the general population, a minority of patients in our
study reported systemic reactions to vaccination, which
included fatigue, fever and pain. Systemic rheumatic
disease flares requiring a change in medication, however,
were uncommon. These data align with a large, physician-
reported registry supported by EULAR COVID-19 data-
base.25 Between 5 February and 27 April 2021, clinicians
Table 4 Adverse events and disease ares after COVID-19 vaccination, reported by patients to be severe and lasting at least
2 days
All
n=2860
Pzer- BioNTech
n=1522
Oxford/AstraZeneca
n=645
Moderna
n=610
Janssen/Johnson &
Johnson n=50
Others*
n=33
Any adverse events 1350 (47.2) 648 (42.6) 335 (51.9) 327 (53.6) 30 (60.0) 10 (30.3)
Fatigue or sleepiness 955 (33.4) 455 (29.9) 229 (35.5) 245 (40.2) 22 (44.0) 4 (12.1)
Headache 792 (27.7) 350 (23.0) 218 (33.8) 196 (32.1) 23 (46.0) 5 (15.2)
Widespread muscle/Joint
pain
653 (22.8) 294 (19.3) 166 (25.7) 176 (28.9) 17 (34.0) 0 (0)
Fever or chills 568 (19.9) 214 (14.1) 167 (25.9) 170 (27.9) 16 (32.0) 1 (3.0)
Anaphylaxis† 6 (0.2) 2 (0.1) 1 (0.2) 1 (0.2) 1 (2.0) 1 (3.0)
Other‡ 204 (7.1) 86 (5.7) 49 (7.6) 64 (10.5) 4 (8.0) 1 (3.0)
Nausea or vomiting 364 (12.7) 167 (11.0) 90 (14.0) 101 (16.6) 6 (12.0) 0 (0)
Any are of rheumatic
disease§
382 (13.4) 184 (12.1) 93 (14.4) 96 (15.7) 7 (14.0) 2 (6.1)
Flare requiring new
or increased dose of
medication§
132 (4.6) 58 (3.8) 40 (6.2) 32 (5.2) 2 (4.0) 0 (0)
*Includes Novavax, Sinovac/Sinopharm, Sputnik V, Cansino, not sure and others.
†Anaphylaxis was not required to last 2 days.
‡Including chest pain/palpitations, other allergic reactions and rash.
§Exacerbation of symptoms or new symptoms attributed to underlying systemic rheumatic disease.
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RMD OpenRMD OpenRMD Open
reported 1519 patients with rheumatic disease who had
received COVID-19 vaccination, the majority (83%) of
whom received an mRNA- based vaccine. Overall, 31%
had potential vaccine- related side effects; 5% had flares
of their underlying systemic rheumatic disease, 1.2% of
which were reported as severe. In two prospective cohorts
of patients with systemic rheumatic disease followed
after COVID-19 vaccination, disease activity remained
stable.26 27 The complementary findings from these two
studies provide reassuring evidence regarding safety and
reactogenicity of COVID-19 vaccination among a systemic
rheumatic disease population.
Strengths of our study include rapid dissemination,
global reach and questions specifically addressing
concerns and willingness to hold specific antirheumatic
medications. Several important limitations should be
acknowledged. First, selection bias may have resulted
from respondents with adverse events being more likely to
fill out the survey. Despite this, the frequency of systemic
rheumatic disease flares requiring medication changes
remained low and was overall consistent with similar
registries. Second, although participants were asked “Has
a doctor ever told you had any of the following rheuma-
tologic diseases?”, report of self- diagnosis or misdiagnosis
is a possibility. However, the reports of treatment with
systemic immunomodulators prescribed by clinicians
and the fact that the distribution of the survey through
patient organisations potentially minimises this making
it unlikely that this could substantially affect the results.
Third, this study was limited to English, Hebrew and
Italian translations of the survey and may not be gener-
alisable to those who speak other languages or reside
in other regions. Translations into other languages are
ongoing and will be reported in the future. Fourth,
respondents were mostly white and reported high levels
of education. These results may not be applicable to
addressing barriers among other racial or ethnic groups
or among other socioeconomic groups.28–30 Fifth, at
the time of the survey, geographic variation in vaccine
availability and access resulted in a preponderance of
UK and US respondents. Sixth, the timing of our survey
coincided with the Centers for Disease Control and Food
and Drug Administration pause on the Janssen/Johnson
& Johnson vaccine,31–33 which limited the number of
responses from those who had received this vaccine.
Seventh, some conditions such as inflammatory myositis
may be over- represented in our cohort, due to the regis-
tries and patient advocacy groups to which our survey was
disseminated most easily. Finally, this was a descriptive
analysis and inferential statistics were intentionally not
performed.
CONCLUSION
This study presents encouraging data regarding commu-
nication between people with systemic rheumatic diseases
and their physicians and to the overall safety of COVID-19
vaccination in this patient population. Reassuringly,
significant flares requiring changes in medications were
relatively infrequent. Clinicians should maintain aware-
ness of changing guidelines as further data become avail-
able to provide continued communication and patient
counselling regarding risks and benefits of vaccination.
Future studies should assess the degree to which vaccine
immunogenicity and reactogenicity among individuals
with systemic rheumatic disease differ compared with the
general population. Further knowledge about barriers to
vaccination in different racial and ethnic groups among
patients living with systemic rheumatic diseases is needed.
Author afliations
1Division of Rheumatology, Hospital for Special Surgery, New York, New York,
USA
2Section of Rheumatology, Boston University School of Medicine, Boston,
Massachusetts, USA
3Health Research Methods, Evidence, and Impact, McMaster University, Hamilton,
Ontario, Canada
4Medicine, McMaster University, Hamilton, Ontario, Canada
5Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin,
USA
6Department of Biochemistry & Biomedical Sciences, McMaster University Faculty
of Science, Hamilton, Ontario, Canada
7Rheumatology, Shefeld Teaching Hospitals NHS Foundation Trust, Shefeld, UK
8Research Unit, Mexican College of Rheumatology, Coyoacan, Ciudad de México,
Mexico
9Rheumatology, Sorbonne Université, Paris, France
10Department of Internal Diseases, Rheumatology Centre, Paul Stradins Clinical
University Hospital, Riga, Latvia
11Rheumatology, Saint James's Hospital, Dublin, Ireland
12Community Medicine, GMC Patiala, Punjab, India
13Department of Rheumatology, Saint James's Hospital, Dublin, Ireland
14Autoinammatory Alliance, San Francisco, California, USA
15Rheumatology and Clinical Immunology, Faculty of Medicine, Cairo University,
Cairo, Egypt
16Rheumatology Department, The Queen Elizabeth Hospital, Adelaide, South
Australia, Australia
17Department of Medicine, University of Adelaide, Adelaide, South Australia,
Australia
18Spondylitis Association of America, Van Nuys, California, USA
19Medical Department I, Department for Rheumatology and Clinical Immunology,
University Hospital Schleswig- Holstein Campus Kiel, Kiel, Schleswig- Holstein,
Germany
20Section of Rheumatology, Allergy & Immunology, Yale School of Medicine, New
Haven, Connecticut, USA
21Section of Rheumatology, VA Connecticut Healthcare System—West Haven
Campus, West Haven, Connecticut, USA
22Rheumatology, Specialized Medical Center Hospital, Riyadh, Saudi Arabia
23Department of Internal Medicine, Division of Rheumatology, Saint Louis University,
Saint Louis, Missouri, USA
24Medicine/Rheumatology, Washington University in Saint Louis School of Medicine,
Saint Louis, Missouri, USA
25Rheumatology, Austin Health, Heidelberg West, Victoria, Australia
26Clinical Pharmacology and Therapeutics, Austin Health, Heidelberg, Victoria,
Australia
27I- Shou University College of Medicine, Yanchau Sheng, Taiwan
28Medicine, University of California San Diego, La Jolla, California, USA
29Italian National Patient Association for Rehumatoid and Rare Disease (APMARR),
Rome, Italy
30The Israeli Association for RMD Patients "Mifrakim Tz'eirim", Haifa, Israel
31Relapsing Polychondritis Foundation, International Relapsing Polychondritis
Research Network, Walnut Creek, California, USA
32Department of Medicine, University of Alabama at Birmingham, Birmingham,
Alabama, USA
33Medicine Service, Birmingham Veterans Affairs Medical Center, Birmingham,
Alabama, USA
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9
Sattui SE, etal. RMD Open 2021;7:e001814. doi:10.1136/rmdopen-2021-001814
InfectionsInfectionsInfections
34Medicine, Division of Rheumatology, University of Washington, Seattle,
Washington, USA
35Department of Rheumatology, Universidad Cientica del Sur, Lima, Peru
36Universidad Cientíca del Sur, Lima, Peru
37Autoinammatory UK, Edinburgh, UK
38Division of Rheumatology, University of Texas Southwestern Medical School,
Dallas, Texas, USA
39Crystal Run Healthcare, Middletown, New York, USA
40Irish Children's Arthritis Network (iCAN), Tipperary, Ireland
41Department of Medicine, Malaghan Institute of Medical Research, Wellington,
New Zealand
42MRC Centre for Neuromuscular Diseases, University College London, London, UK
43Rheumatology, University College London Centre for Rheumatology, London, UK
44Faculty of Medicine, The University of Queensland, Herston, Queensland, Australia
45Metro North Hospital & Health Service, Royal Brisbane and Woman's Hospital
Health Service District, Herston, Queensland, Australia
46Healthpartners, St Paul, Minnesota, USA
47Clinical Epidemiology Program and Rheumatology Unit, Division of
Rheumatology,Allergy, and Immunology, Massachusetts General Hospital, Boston,
Massachusetts, USA
48Department of Medicine, Harvard Medical School, Boston, Massachusetts, USA
49Medicine/Rheumatology, University of California, San Francisco, California, USA
50LupusChat, New York, New York, USA
51Division of Clinical Immunology and Allergy, McMaster University Department of
Medicine, Hamilton, Ontario, Canada
52Department of Health Research Methods, Evidence and Impact (HEI), McMaster
University Faculty of Health Sciences, Hamilton, Ontario, Canada
53Department of Health Research Methods, Evidence, and Impact (HEI); Medicine,
McMaster University, Hamilton, Ontario, Canada
54Environmental Autoimmunity Group, NIEHS/NIH/DHHS, Bethesda, Maryland, USA
55Rheumatology, Boston Children's Hospital, Boston, Massachusetts, USA
56Division of Rheumatology and Clinical Immunology, Beth Israel Deaconess
Medical Center, Boston, Massachusetts, USA
57Epidemiology and Population Health and Department of Medicine, Division of
Immunology & Rheumatology, Stanford School of Medicine, Stanford, California,
USA
58Department of Medicine, Clinical Epidemiology Unit, Sweden
59Department of Medicine, Division of Rheumatology, Inammation, and Immunity,
Brigham and Women's Hospital, Boston, Massachusetts, USA
Twitter Sebastian Eduardo Sattui @SattuiSEMD, Manuel Francisco Ugarte- Gil @
mugartegil, Pedro M Machado @pedrommcmachado and Philip C Robinson @
philipcrobinson
Acknowledgements We would like to thank Saskya Angevare, Richard P Beesley,
Eugenia Chock, Berk Degirmenci, Christele Felix, Shangyi Jin, Elsa Mateus, Andrea
Peirce, Esra Sari, Robert Tseng, Leslie Wang and Erick Adrian Zamora for their
invaluable contributions to the GRA Vaccine Survey.
Contributors SES, JL, KK, ES and MP contributed to data collection, data quality
control, data analysis and interpretation. They drafted and revised the manuscript
critically for important intellectual content and gave nal approval of the version
published. AA, DA- R, FB, IB, RC, ADS, ED, KD, TAG, CLH, RAH, BFH, EH, LEK, AK,
AHK, DFLL, CL BM, SM, MN, JASi, NS, MFU- G, JW and KJY critically revised the
manuscript and provided intellectual content. TTM, CH, MLarche, MLevine, GF,
LT and LGR contributed to planning and data collection, reviewed the manuscript
and provided important intellectual content. SB, WC, RG, PMM, PCR, PS, ZW and
JY contributed to the acquisition, analysis and interpretation of the data. They
drafted and revised the manuscript critically for important intellectual content
and gave nal approval of the version published. JAS, JS and JH directed the
work, designed the data collection methods and contributed to the analysis and
interpretation of the data. They drafted and revised the manuscript critically
for important intellectual content and gave nal approval of the version to be
published. SES, JWL, KK, JSimard and JSparks had full access to the data and
verify the credibility of the underlying data. All authors have read, revised and
approved this manuscript and nal responsibility for the decision to submit for
publication.
Funding This study was supported by the European Alliance of Associations for
Rheumatology and American College of Rheumatology Research and Education
Foundation. Dr. Lisa Rider's involvement was supported in part by the Intramural
Research Program of the National Institutes of Health, National Institute of
Environmental Health Sciences.
Disclaimer The views expressed here are those of the authors and participating
members of the COVID-19 Global Rheumatology Alliance and do not necessarily
represent the views of the American College of Rheumatology (ACR), EULAR, the
(UK) National Health Service (NHS), the National Institute for Health Research
(NIHR) or the (UK) Department of Health, or any other organisation. The funders had
no role in the decision to publish or preparation of this manuscript. The content
is solely the responsibility of the authors and does not necessarily represent the
ofcial views of Harvard University, its afliated academic health care centers, or
the National Institutes of Health.
Competing interests SES has received funding from the Vasculitis Foundation
and the Vasculitis Clinical Research Consortium unrelated to this work. JL has
received research grant funding from Pzer unrelated to this work. ES is a Board
Member of the Canadian Arthritis Patient Alliance, a patient run, volunteer-
based organisation whose activities are primarily supported by independent
grants from pharmaceutical companies. MP was supported by a Rheumatology
Research Foundation Scientist Development grant. DA- R is a Scientic Advisor for
GlaxoSmithKilne unrelated to this work. FB reports personal fees from Boehringer,
Bone Therapeutics, Expanscience, Galapagos, Gilead, GSK, Merck Sereno, MSD,
Nordic, Novartis, Pzer, Regulaxis, Roche, Sandoz, Sano, Servier, UCB, Peptinov,
TRB Chemedica and 4P Pharma outside of the submitted work. No funding relevant
to this manuscript. RC: speakers bureau for Janssen, Roche, Sano, AbbVie.
KD reports no COI- unpaid volunteer president of the Autoinammatory Alliance.
Any grants or funding from pharma is received by the non- prot organisation
only. CLH received funding under a sponsored research agreement unrelated to
the data in the paper from Vifor Pharmaceuticals. LeK has received a research
grant from Lilly unrelated to this work. AHJK participated in consulting, advisory
board or speaker's bureau for Alexion Pharmaceuticals, Aurinia Pharmaceuticals,
Annexon Biosciences, Exagen Diagnostics and GlaxoSmithKilne and received
funding under a sponsored research agreement unrelated to the data in the
paper from GlaxoSmithKline. JSingh has received consultant fees from Crealta/
Horizon, Medisys, Fidia, PK Med, Two Labs, Adept Field Solutions, Clinical Care
Options, Clearview Healthcare Partners, Putnam Associates, Focus Forward,
Navigant Consulting, Spherix, MedIQ, Jupiter Life Science, UBM, Trio Health,
Medscape, WebMD and Practice Point Communications; and the National
Institutes of Health and the American College of Rheumatology. JSingh owns
stock options in TPT Global Tech, Vaxart Pharmaceuticals and Charlotte’s Web
Holdings. JSingh previously owned stock options in Amarin, Viking and Moderna
Pharmaceuticals. JSingh is on the speaker’s bureau of Simply Speaking. JSingh is
a member of the executive of Outcomes Measures in Rheumatology (OMERACT),
an organisation that develops outcome measures in rheumatology and receives
arms- length funding from eight companies. JSingh serves on the FDA Arthritis
Advisory Committee. JSingh is the chair of the Veterans Affairs Rheumatology
Field Advisory Committee. JSingh is the editor and the Director of the University of
Alabama at Birmingham (UAB) Cochrane Musculoskeletal Group Satellite Center
on Network Meta- analysis. NSingh is supported by funding from the Rheumatology
Research Foundation Investigator Award and the American Heart Association.
MFU- G has received research support from Pzer and Janssen, unrelated to this
work. SB reports personal fees from Novartis, AbbVie, Pzer and Horizon Pharma,
outside the submitted work. RG reports personal fees from AbbVie New Zealand,
Cornerstones, Janssen New Zealand and personal fees and non- nancial support
Pzer New Zealand (all <US$10 000) outside the submitted work. PMM reports
personal fees from AbbVie, Eli Lilly, Janssen, Novartis, Pzer and UCB, grants and
personal fees from Orphazyme, outside the submitted work. PCR reports personal
fees from AbbVie, Gilead, Lilly and Roche, grants and personal fees from Novartis,
UCB Pharma, Janssen and Pzer and non- nancial support from BMS, outside the
submitted work. PS reports honoraria from Social media editor for @ACR_Journals,
outside the submitted work. ZSW reports grants from NIH, BMS and Principia/
Sano and personal fees from Viela Bio and MedPace, outside the submitted work.
JY reports personal fees from Pzer and Eli Lilly, and grants and personal fees
from AstraZeneca, outside the submitted work. MJL reports grants from American
College of Rheumatology, during the conduct of the study and consulting fees
from AbbVie, Amgen, Actelion, Boehringer Ingelheim, BMS, Celgene, Gilead, J&J,
Mallinckrodt, Novartis, Pzer, Roche, Sandoz, Sano, Sobi and UCB, outside the
submitted work. LGR was supported by the Intramural Research Program of the
National Institute of Environmental Health Sciences (NIEHS; ZIAES101074) of
the National Institutes of Health. JH reports grants from Childhood Arthritis and
Rheumatology Research Alliance (CARRA) and Rheumatology Research Alliance,
and personal fees from Novartis, Pzer and Biogen, outside the submitted work.
JSimard received research grant funding from the National Institutes of Health
unrelated to this work (NIAMS: R01 AR077103 and NIAID R01 AI154533). JSparks
has performed consultancy for AbbVie, Boehringer Ingelheim, Bristol- Myers Squibb,
Gilead, Inova Diagnostics, Optum and Pzer unrelated to this work.
Patient consent for publication Not required.
Ethics approval The study was deemed exempt from full review by the Boston
Children's Hospital institutional review board.
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10 Sattui SE, etal. RMD Open 2021;7:e001814. doi:10.1136/rmdopen-2021-001814
RMD OpenRMD OpenRMD Open
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request.
Researchers interested in performing additional analyses from survey data are
invited to submit proposals through the COVID-19 Global Rheumatology Alliance at
rheum- covid. org. For approved projects, we will be able to provide summary tables
and data analyses as requested. We do not currently have IRB approval to make
the raw data available to other researchers.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the
use is non- commercial. See:http:// creativecommons. org/ licenses/ by- nc/ 4. 0/.
ORCID iDs
Sebastian EduardoSattui http:// orcid. org/ 0000- 0002- 3945- 6828
KevinKennedy http:// orcid. org/ 0000- 0001- 8230- 091X
EmilySirotich http:// orcid. org/ 0000- 0002- 7087- 8543
AkpabioAkpabio http:// orcid. org/ 0000- 0002- 4920- 6494
DeshiréAlpízar- Rodríguez http:// orcid. org/ 0000- 0002- 6930- 0517
FrancisBerenbaum http:// orcid. org/ 0000- 0001- 8252- 7815
RichardConway http:// orcid. org/ 0000- 0003- 2538- 3362
Alfred HyoungjuKim http:// orcid. org/ 0000- 0003- 4074- 0516
Jasvinder ASingh http:// orcid. org/ 0000- 0003- 3485- 0006
Manuel FranciscoUgarte- Gil http:// orcid. org/ 0000- 0003- 1728- 1999
Pedro MMachado http:// orcid. org/ 0000- 0002- 8411- 7972
Philip CRobinson http:// orcid. org/ 0000- 0002- 3156- 3418
Jonathan SHausmann http:// orcid. org/ 0000- 0003- 0786- 8788
Julia FSimard http:// orcid. org/ 0000- 0001- 5735- 9856
Jeffrey ASparks http:// orcid. org/ 0000- 0002- 5556- 4618
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... Fear of side effects was one of the main reasons for declining COVID-19 vaccination (20). On the other hand, some reports indicate that after receiving the COVID-19 vaccine, up to one-third of SLE patients experienced a flare, although the majority of cases were mild (21,22). This may decrease the willingness to be vaccinated among these individuals. ...
Article
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Background: Individuals with Autoimmune Rheumatic Disease (AIRD) are vulnerability to severe SARS-CoV-2 outcomes and vaccination. The present study aimed to determine the incidence of AIRDs flares following COVID-19 vaccination and its risk factors. Methods: The study was retrospective cross-sectional focused on patients with AIRD who experienced a flare-up at least during 30 days after receiving the COVID-19 vaccine. These patients were seen at Rheumatology Clinics at Imam Reza and Ghaem Hospitals, affiliated with Mashhad University of Medical Sciences, as well as private clinics in Mashhad, Iran, over a period of 1 years. Results: The rate of recurrence following COVID-19 vaccination was estimated to be 3.16%. Rheumatoid arthritis (18.9%), systemic lupus erythematosus (12.9%), and cutaneous vasculitis (10.6%) were the most frequent AIRDs among patients who experienced a flare-up following COVID-19 vaccination. More than 85% of patients who were vaccinated with AstraZeneca experienced a flare-up after the first dose of vaccination. In the majority of patients, the flare-up occurred after the first dosage of COVID-19 vaccination. Conclusion: In Mashhad, Iran, the incidence of flare-ups in autoimmune and inflammatory rheumatic diseases following COVID-19 vaccination is estimated to be a mere 3%. Despite their rarity, flare-ups in autoimmune and inflammatory rheumatic diseases post-COVID-19 vaccination can still pose a public health issue, potentially undermining public confidence in vaccinations.
... The same group also has the highest risk of complications arising from COVID-19 [3]. Short-term safety data for COVID-19 vaccination are reassuring in both healthy and high-risk groups, including those with IMIDs [4][5][6][7][8]. ...
Article
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This study aimed to assess COVID-19 vaccination-related AEs in patients with rheumatoid arthritis (RA), in the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 study. An online international cross-sectional survey captured self-reported data on COVID-19 vaccination-related adverse events (AEs) in people with RA, autoimmune diseases (AIDs; rheumatic [r] and non-rheumatic [nr]) and healthy controls (HCs). The survey was circulated by the COVAD study group, comprising 157 collaborators across 106 countries, from February to June 2022. Delayed AEs among RA were compared with other rAIDs, nrAIDs and HCs using multivariable binary regression. A total of 7203 participants were included (1423 [19.7%] RA, 2620 [36.4%] rAIDs, 426 [5.9%] nrAIDs, 2734 [38%] HCs), with 75% female. Compared to HCs, individuals with RA reported higher overall major AEs [OR 1.3 (1.0–1.7)], and an increased number of several minor AEs. Compared to nrAIDs, people with RA had several increased reported minor AEs including myalgia and joint pain. People with active RA had increased major AEs [OR 1.8 (1.1–3.0)] and hospitalisation [OR 4.1 (1.3 – 13.3)] compared to inactive RA. RA patients without autoimmune comorbidities had significantly fewer major and minor AEs than those with other rAIDs. A decreased incidence of hospitalisation was seen in patients taking methotrexate or TNF inhibitors compared to patients not taking these medications. COVID-19 vaccination is associated with minimal to no risks of delayed AEs in patients with RA compared to HCs, and fewer compared to other rAIDs. Active RA and presence of co-existing rAIDs were associated with an increased risk of delayed AEs.
... Over the last few years, several immunizers have been studied without any significant risk of worsening symptoms related to IMRDs being observed. In distinct scenarios where reactivation is observed, it is generally of mild intensity, short duration and does not require an increase in the degree of immunosuppression [42][43][44]. Systematic vaccination of patients with RA is recommended by the BSR and reaffirmed in international guidelines such as the EULAR [12,45]. ...
Article
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Background Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with associated comorbidities. However, few studies have assessed the safety of the COVID-19 vaccine in patients with RA. Objective To evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. Methods This data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. Results A total of 188 patients with RA were include, 90% female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The most common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32 %, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,4% vs 25%, p = 0.02) and pain at injection (51,4% vs 27%, p = 0.001) were more common with ChAdOx1. No serious AEs were related. With Regard to RA activity level, no significant difference was observed between the three time periods for both COVID-19 vaccines. Conclusion In the comparison between the two immunizers in patients with RA, local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than with CoronaVac, especially after the first dose. In summary, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.
... Previous rates of post-COVID-vaccine AEs in RMD patients were similar to this work, ranging from 70.2% to 81%, 10,13 but lower rates were observed in the European Coronavirus Vaccine (COVAX) registry (47%), and in the COVID-19 Global Rheumatology Alliance Vaccine Survey (37%). 7,14 In a real-world digital cohort study including fully vaccinated healthy adults from the US, 8947 of 11 140 (80.3%) reported AEs 15 . A questionnaire from the Netherlands reported that 258 (51%) patients and 106 (52%) controls had at least one mild AE, and 105 (21%) patients and 38 (19%) controls reported moderate AEs after the first COVID-19 vaccine dose. ...
... In a Chinese study, willingness was 30%, but following physician recommendations, it rose to 90% [23]. In contrast, most other studies demonstrated positive attitudes of lupus patients towards the COVID-19 vaccine, reaching 76-80% [24,25]. ...
Article
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Objective: To assess the tolerance and effects of COVID-19 vaccination in Egyptian patients with systemic lupus erythematosus (SLE), such as incident flare risk, based on the patient’s perspective. Methods: SLE patients were included in this multicenter cross-sectional questionnaire-based analysis. Data included demographic and clinical features, prior COVID-19 infection, vaccine acceptability, type of vaccination, disease status before and after vaccination, and related side effects. Results: The total number of patients included was 230. Ages ranged from 18 to 64 years, disease duration from 1 to 15 years, and 92.6% were females. Only 31.7% of the study population were COVID-infected; most (70.7%) were treated at home, while 1.2% needed ICU. In contrast, 53% of our patients were vaccinated, and 47% were not vaccinated, primarily due to fear of side effects or disease flare. After the first dose of vaccination, 44.1% reported vaccine-related side effects, of which fatigue, fever, myalgia, as well as injection site reaction were the prevalent complications. The highest incidence of side effects was in AstraZeneca (78%), while the least was in Sinopharm (29.6%). 16.3% of vaccinated patients were COVID infected after vaccination, and 88.2% were treated at home. Only 14.6% of the vaccinated population experienced a lupus flare, primarily after the first dose, with no significant difference between the type of vaccine and lupus flares. Conclusion: The acceptance of COVID-19 vaccination among our lupus patients was neutral. The observed adverse effects were comparable to those reported by healthy individuals. Post-vaccination lupus flares were infrequent and unrelated to the vaccine type but rather to the pre-vaccination disease activity state. Keywords: Lupus, COVID, Vaccine, Flare
... It has been established that immunization is one of the most important tools for the control of the COVID-19 pandemic [1]. The safety and effectiveness of COVID-19 immunizations have been established for the general population, and some studies have been performed including patients with autoimmune conditions [2,3]. However, patients with rare diseases such as systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still's disease (AOSD) were not well represented in these studies. ...
Article
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Background Patients with systemic juvenile idiopathic arthritis (sJIA) and adult-onset Still’s disease (AOSD) have been under-represented in studies about safety of the COVID-19 immunization. We aimed to inquire about the safety and tolerability of COVID-19 immunization in this population. Methods An anonymous online survey on closed Facebook groups for patients and parents with self-reported sJIA/AOSD was posted from June 27th until August 30th, 2022. Continuous variables were analyzed using t-tests or the Mann-Whitney U test if non-normally distributed. Fisher`s tests were used for categorical variables. Results Of a total of 167 responses, 17 were excluded. Ninety-nine patients received the COVID-19 immunization, and 51 patients did not. Patients in both immunized and unimmunized groups had a similar history of disease complications such as macrophage activation syndrome (50% vs. 49%), lung disease (17% vs. 29%), arthritis (51% vs. 50%), and pericarditis/myocarditis (10% vs. 8%). Unimmunized patients were younger (median age 8 yo vs. 12 yo, p < 0.001) and had a higher incidence of a history of disease flare or severe side effects with other immunizations (24% vs. 4%, p < 0.001). Thirty-nine patients reported mostly mild immunization side effects. Severe side effects included 6 reports of disease flare and 2 reports of cardiac side effects (pericarditis and atrial fibrillation). Seven patients reported side effects lasting ≥ 8 days. Three patients developed AOSD following COVID-19 immunization, and 2 of them had the only hospital admissions for immunization side effects. Regarding COVID-19 infection, 46 patients were infected without full immunization, and 33 were infected after 2 doses of immunization. There was one hospitalization in the immunized group, compared to one ICU admission leading to death in the non-immunized group. There was a trend (p > 0.05) toward a higher risk of disease flare after COVID-19 infection among non-immunized patients (43%), compared to immunized patients (24%). Conclusions The COVID-19 immunization was well tolerated by sJIA/AOSD patients even in this group of patients with severe disease. There was a low incidence of disease flare with immunization. Most immunization side effects were mild and lasted < 7 days. The only ICU admission and death from COVID-19 infection occurred in unimmunized subjects.
... In distinct scenarios where reactivation is observed, it is generally of mild intensity, short duration and does not require an increase in the degree of immunosuppression. 42,43,44 Systematic vaccination of patients with RA is recommended by the BSR and rea rmed in international guidelines such as the EULAR. 12,45 Although immunosuppressed patients were excluded from phase 3 clinical trials of the e cacy and safety of immunizers against SARS-CoV-2, their vaccination was considered a priority due to the increased risk of hospitalization and death from COVID-19. ...
Preprint
Full-text available
BACKGROUND Patients with immune-mediated rheumatic diseases (IMRDs) have been prioritized for COVID-19 vaccination to mitigate the infection severity risks. Patients with rheumatoid arthritis (RA) are at a high risk of severe COVID-19 outcomes, especially those under immunosuppression or with comorbidities associated. However, few studies in the literature assessed the safety of the COVID-19 vaccine in patients with RA. OBJECTIVE Evaluate the safety of vaccines against SARS-CoV-2 in patients with RA. METHODS These data are from the study “Safety and Efficacy on COVID-19 Vaccine in Rheumatic Diseases,” a Brazilian multicentric prospective phase IV study to evaluate COVID-19 vaccine in IMRDs in Brazil. Adverse events (AEs) in patients with RA of all centers were assessed after two doses of ChAdOx1 (Oxford/AstraZeneca) or CoronaVac (Sinovac/Butantan). Stratification of postvaccination AEs was performed using a diary, filled out daily and returned at the end of 28 days for each dose. RESULTS A total of 188 patients with RA were include in the study, most of them female. CoronaVac was used in 109 patients and ChAdOx1 in 79. Only mild AEs were observed, mainly after the first dose. The more common AEs after the first dose were pain at the injection (46,7%), headache (39,4%), arthralgia (39,4%), myalgia (30,5%) and fatigue (26,6%), and ChAdOx1 had a higher frequency of pain at the injection (66% vs 32%, p < 0.001) arthralgia (62% vs 22%, p < 0.001) and myalgia (45% vs 20%, p < 0.001) compared to CoronaVac. The more common AEs after the second dose were pain at the injection (37%), arthralgia (31%), myalgia (23%), headache (21%) and fatigue (18%). Arthralgia (41,42% vs 25%, p = 0.02) and pain at injection (51,43% vs 27%, p = 0.001) were more common with ChAdOx1. Only nonsevere AEs were related, and no patients had flare after the vaccination. CONCLUSION In the comparison between the two immunizers in patients with RA, the local reactions and musculoskeletal symptoms were more frequent with ChAdOx1 than in CoronaVac, especially in the first dose. In general, the AE occurred mainly after the first dose, and were mild, like previous data from others immunizing agents in patients with rheumatoid arthritis. Vaccination did not worsen the degree of disease activity.
... Strengthening the evidence around the safety of COVID-19 vaccinations can help increase vaccine confidence (12)(13)(14). Our objective was to determine, using a population-based sample, whether COVID-19 vaccination is associated with an increased risk of AESIs and health care use ...
Article
Objective To determine if COVID-19 vaccines were associated with adverse events of special interest (AESIs) and health care use among adults with rheumatoid arthritis (RA). Methods Among adults with RA who received at least 1 COVID-19 vaccine, a self-controlled case series (SCCS) analysis was conducted to evaluate relative incidence (RI) rates of AESIs (Bell's Palsy, Idiopathic Thrombocytopenia, Acute Disseminated Encephalomyelitis, Pericarditis/Myocarditis, Guillain-Barre syndrome, Transverse Myelitis, Myocardial Infarction, Anaphylaxis, Stroke, Deep Vein Thrombosis, Pulmonary Embolism, Narcolepsy, Appendicitis, and Disseminated Intravascular Coagulation) in any 21-day period following vaccination compared to control periods. Secondary outcomes included emergency department (ED) visits, hospitalizations, and rheumatology visits. A matched non-RA comparator group was created and a separate SCCS analysis was conducted. Relative incidence ratios (RIR) were used to compare between RA and non-RA groups. Results Among 123,466 RA patients and 493,864 comparators, the majority received mRNA vaccines. For RA patients, relative to control periods, AESIs were not increased. ED visits increased after dose 2 [RI:1.06 (95%CI:1.03-1.10)] and decreased after dose 3 [RI:0.93 (95%CI:0.89-0.96)]. Hospitalizations were lower after the first [RI:0.83 (95%CI:0.78-0.88)], second [RI:0.86 (95%CI:0.81-0.92)], and third [RI:0.89 (95%CI:0.83-0.95)] doses. Rheumatology visits increased after dose 1 [RI:1.08 (95%CI:1.07-1.10)], and decreased after doses 2 and 3. Relative to comparators, RA patients had a higher AESI risk after dose 3 [RIR:1.28 (95%CI:1.1- 1.6)]. RA patients experienced fewer ED visits [RIR:0.73 (95%CI:0.58-0.90)] and hospitalizations [RIR:0.52 (95%CI:0.36-0.75)] after dose 4. Conclusion COVID-19 vaccines in RA patients was not associated with an increase in AESI risk or health care utilization after every dose.
... Flares of the primary disease after COVID-19 vaccination have been reported in autoimmune diseases, including systemic rheumatic diseases (13), systemic lupus erythematosus (14,15), and hematologic diseases, including idiopathic thrombocytopenic purpura (16), paroxysmal nocturnal hemoglobinuria (17), and IgA nephropathy (12,18). Similarly, disease flares after COVID-19 vaccination have been reported in IBD, although only infrequently (19)(20)(21). ...
Article
Objective Flares of inflammatory bowel disease (IBD) can occur infrequently after vaccination for coronavirus disease 2019 (COVID-19), although the details of this phenomenon are poorly understood. To clarify the possibility of an unfavorable response in patients with IBD, we investigated IBD-related symptoms during the COVID-19 vaccination. Methods Between October 2021 and February 2022, we obtained the COVID-19 vaccination status of 411 IBD patients who were being treated at our institution. The disease course of IBD after vaccination was investigated in 188 patients with ulcerative colitis (UC) and 119 patients with Crohn's disease (CD) who had received at least one dose of the vaccine during the clinical remission phase. The baseline characteristics before vaccination were compared between the patients with UC with or without disease flares. Results During the 30-day follow-up period, eight patients with UC (4.3%) and one patient with CD (0.8%) experienced disease flares following vaccination. Disease flares occurred after the first vaccination in six patients and after the second vaccination in three patients. As for the timing of onset of disease flares, eight events (88.9%) occurred within one week of vaccination. Two patients required hospitalization, and one patient with CD required surgery for an intra-abdominal abscess. The baseline characteristics did not significantly differ between patients with UC who experienced flares and those who did not. Conclusions IBD flares following COVID-19 vaccination are rare and vaccination should therefore be recommended for patients with IBD. However, the possibility of disease flares should be considered for approximately one week after each vaccination, especially in patients with UC.
Article
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Objectives: The main purpose of this study was to determine the frequency of COVID-19 vaccine side effects in patients with rheumatic diseases and to examine any potential associations with medications, disease type, or comorbidities. Methods: A multicentre cross-sectional study from rheumatology units in different hospitals in Iraq was carried out between 8th of August 2021 and 4th of August 2022. Patients were eligible for inclusion if they have a rheumatic disease and have taken one or more doses of any COVID-19 vaccine. Results: A total of 661 (57.8% female, mean age 46.51± 12.97 years) patients with rheumatic illnesses who received the “COVID-19” vaccination were included in this study. Rheumatoid arthritis was the most frequent diagnostic group. The Pfizer vaccine was given to the majority of patients (74.6%), followed by Sinopharm (16.2%), and AstraZeneca (9.2%). Side effects were detected in 661(100%) and 528 (100%) patients following the first and second vaccination doses, respectively; among which the most frequent were injection site pain in 57.8% following the first dose and 47.6% after the second dose, followed by fatigue and fever. According to multivariate logistic regression models, age (B=-0.204, p = 0.000), had a significantly inverse correlation coefficient with the experience of greater side effects. Rheumatic disease flares reported in 9.9%, 10.3%, and 8.2% of patients who received the Pfizer, Sinopharm, and AstraZeneca vaccines, respectively. Conclusion: The “COVID-19” vaccination has a reassuring safety profile with no greater risk of adverse events in any specific illness or pharmacological therapy
Article
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Objective To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID‐19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). Methods A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID‐19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9‐point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. Results Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID‐19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. Conclusion These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID‐19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.
Article
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Introduction Vaccination represents a cornerstone in mastering the COVID-19 pandemic. Data on immunogenicity and safety of messenger RNA (mRNA) vaccines in patients with autoimmune inflammatory rheumatic diseases (AIIRD) are limited. Methods A multicentre observational study evaluated the immunogenicity and safety of the two-dose regimen BNT162b2 mRNA vaccine in adult patients with AIIRD (n=686) compared with the general population (n=121). Serum IgG antibody levels against SARS-CoV-2 spike S1/S2 proteins were measured 2–6 weeks after the second vaccine dose. Seropositivity was defined as IgG ≥15 binding antibody units (BAU)/mL. Vaccination efficacy, safety, and disease activity were assessed within 6 weeks after the second vaccine dose. Results Following vaccination, the seropositivity rate and S1/S2 IgG levels were significantly lower among patients with AIIRD versus controls (86% (n=590) vs 100%, p<0.0001 and 132.9±91.7 vs 218.6±82.06 BAU/mL, p<0.0001, respectively). Risk factors for reduced immunogenicity included older age and treatment with glucocorticoids, rituximab, mycophenolate mofetil (MMF), and abatacept. Rituximab was the main cause of a seronegative response (39% seropositivity). There were no postvaccination symptomatic cases of COVID-19 among patients with AIIRD and one mild case in the control group. Major adverse events in patients with AIIRD included death (n=2) several weeks after the second vaccine dose, non-disseminated herpes zoster (n=6), uveitis (n=2), and pericarditis (n=1). Postvaccination disease activity remained stable in the majority of patients. Conclusion mRNA BNTb262 vaccine was immunogenic in the majority of patients with AIIRD, with an acceptable safety profile. Treatment with glucocorticoids, rituximab, MMF, and abatacept was associated with a significantly reduced BNT162b2-induced immunogenicity.
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Importance The impact of COVID-19 in the US has been far-reaching and devastating, especially in Black populations. Vaccination is a critical part of controlling community spread, but vaccine acceptance has varied, with some research reporting that Black individuals in the US are less willing to be vaccinated than other racial/ethnic groups. Medical mistrust informed by experiences of racism may be associated with this lower willingness. Objective To examine the association between race/ethnicity and rejection of COVID-19 vaccine trial participation and vaccine uptake and to investigate whether racial/ethnic group–based medical mistrust is a potential mediator of this association. Design, Setting, and Participants This cross-sectional survey study was conducted from June to December 2020 using a convenience sample of 1835 adults aged 18 years or older residing in Michigan. Participants were recruited through community-based organizations and hospital-academic networks. Main Outcomes and Measures Separate items assessed whether respondents, if asked, would agree to participate in a research study to test a COVID-19 vaccine or to receive a COVID-19 vaccine. Participants also completed the suspicion subscale of the Group-Based Medical Mistrust Scale. Results Of the 1835 participants, 1455 (79%) were women, 361 (20%) men, and 19 (1%) other gender. The mean (SD) age was 49.4 (17.9) years, and 394 participants (21%) identified as Black individuals. Overall, 1376 participants (75%) reported low willingness to participate in vaccine trials, and 945 (52%) reported low willingness to be vaccinated. Black participants reported the highest medical mistrust scores (mean [SD], 2.35 [0.96]) compared with other racial/ethnic groups (mean [SD] for the total sample, 1.83 [0.91]). Analysis of path models revealed significantly greater vaccine trial and vaccine uptake rejection among Black participants (vaccine trial: B [SE], 0.51 [0.08]; vaccine uptake: B [SE], 0.51 [0.08]; both P < .001) compared with the overall mean rejection. The association was partially mediated by medical mistrust among Black participants (vaccine trial: B [SE], 0.04 [0.01]; P = .003; vaccine uptake: B [SE], 0.07 [0.02]; P < .001) and White participants (vaccine trial: B [SE], −0.06 [0.02]; P = .001; vaccine uptake: B [SE], −0.10 [0.02]; P < .001). Conclusions and Relevance In this survey study of US adults, racial/ethnic group–based medical mistrust partially mediated the association between individuals identifying as Black and low rates of acceptance of COVID-19 vaccine trial participation and actual vaccination. The findings suggest that partnerships between health care and other sectors to build trust and promote vaccination may benefit from socially and culturally responsive strategies that acknowledge and address racial/ethnic health care disparities and historical and contemporary experiences of racism.
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Introduction In light of the SARS-CoV-2 pandemic, protecting vulnerable groups has become a high priority. Persons at risk of severe disease, for example, those receiving immunosuppressive therapies for chronic inflammatory cdiseases (CIDs), are prioritised for vaccination. However, data concerning generation of protective antibody titres in immunosuppressed patients are scarce. Additionally, mRNA vaccines represent a new vaccine technology leading to increased insecurity especially in patients with CID. Objective Here we present for the first time, data on the efficacy and safety of anti-SARS-CoV-2 mRNA vaccines in a cohort of immunosuppressed patients as compared with healthy controls. Methods 42 healthy controls and 26 patients with CID were included in this study (mean age 37.5 vs 50.5 years). Immunisations were performed according to national guidelines with mRNA vaccines. Antibody titres were assessed by ELISA before initial vaccination and 7 days after secondary vaccination. Disease activity and side effects were assessed prior to and 7 days after both vaccinations. Results Anti-SARS-CoV-2 antibodies as well as neutralising activity could be detected in all study participants. IgG titres were significantly lower in patients as compared with controls (2053 binding antibody units (BAU)/mL ±1218 vs 2685±1102). Side effects were comparable in both groups. No severe adverse effects were observed, and no patients experienced a disease flare. Conclusion We show that SARS-CoV-2 mRNA vaccines lead to development of antibodies in immunosuppressed patients without considerable side effects or induction of disease flares. Despite the small size of this cohort, we were able to demonstrate the efficiency and safety of mRNA vaccines in our cohort.
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Objective To provide guidance to rheumatology providers on the use of coronavirus disease 2019 (COVID‐19) vaccines for patients with rheumatic and musculoskeletal diseases (RMDs). Methods A task force was assembled that included 9 rheumatologists/immunologists, 2 infectious disease specialists, and 2 public health physicians. After agreeing on scoping questions, an evidence report was created that summarized the published literature and publicly available data regarding COVID‐19 vaccine efficacy and safety, as well as literature for other vaccines in RMD patients. Task force members rated their agreement with draft consensus statements on a 9‐point numerical scoring system, using a modified Delphi process and the RAND/University of California Los Angeles Appropriateness Method, with refinement and iteration over 2 sessions. Consensus was determined based on the distribution of ratings. Results Despite a paucity of direct evidence, 74 draft guidance statements were developed by the task force and agreed upon with consensus to provide guidance for use of the COVID‐19 vaccines in RMD patients and to offer recommendations regarding the use and timing of immunomodulatory therapies around the time of vaccination. Conclusion These guidance statements, made in the context of limited clinical data, are intended to provide direction to rheumatology health care providers on how to best use COVID‐19 vaccines and to facilitate implementation of vaccination strategies for RMD patients.
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Vaccination against SARS-CoV-2 has become available and will hopefully end the current pandemic. Understandably, patients with inflammatory rheumatic diseases (iRMDs) and their physicians are feverishly preoccupied with questions about vaccination and the vaccines against SARS-CoV-2. However, as it will take months before all patients with iRMDs will have access to the vaccines, measures that are taken now in order to increase potential safety and efficacy of the vaccines may impose a risk for the patients with regard to reactivation of their underlying iRMD. The ad hoc commission ‘Covid-19’ and the board of directors of the German Society for Rheumatology have addressed this topic and have developed considerations, which are intended to answer urgent questions, to take away concerns and fears and to make initial recommendations for patients with iRMDs.
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In view of the COVID-19 pandemic, there is an unmet clinical need for the guidelines on vaccination of patients with autoimmune inflammatory rheumatic diseases (AIIRD). This position paper summarises the current data on COVID-19 infection in patients with AIIRD and development of vaccines against COVID-19, discusses the aspects of efficacy and safety of vaccination, and proposes preliminary considerations on vaccination against COVID-19 in patients with AIIRD, mainly based on the expert opinion and knowledge on the use of other vaccines in this population of patients.
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Background The consequences of the COVID-19 outbreak are unprecedented and have been felt by everyone around the world, including people with rheumatic and musculoskeletal diseases (RMDs). With the development of vaccines, the future is becoming brighter. Vaccines are a key pillar of public health and have been proven to prevent many serious diseases. However, vaccination also raises questions, especially for patients with inflammatory RMDs and/or treated with drugs that influence their immune system. Objectives Our aim was to collect safety data among RMD patients receiving COVID-19 vaccines. Methods The EULAR COVID-19 Vaccination (COVAX) Registry is an observational registry launched on 5 February 2021. Data are entered voluntarily by clinicians or associated healthcare staff; patients are eligible for inclusion if they have an RMD and have been vaccinated against SARS-CoV-2. Descriptive statistics are presented. Results As of 27 April 2021, 1519 patients were reported to the registry. The majority were female (68%) and above the age of 60 (57%). Mean age was 63 years (SD 16), ranging from 15 to 97 years. A total of 28 countries contributed to the registry, with France (60%) and Italy (13%) as the highest contributors. The majority (91%) had inflammatory RMDs. Inflammatory joint diseases accounted for 51% of cases, connective tissue diseases 19%, vasculitis 16%, other immune mediated inflammatory diseases 4%, and non-inflammatory/mechanical RMDs 9%. The most frequent individual diagnoses were rheumatoid arthritis (30%), axial spondyloarthritis (8%), psoriatic arthritis (8%), systemic lupus erythematosus (SLE, 7%) and polymyalgia rheumatica (6%). At the time of vaccination, 45% were taking conventional synthetic DMARDs, 36% biological DMARDs, 31% systemic glucocorticoids, 6% other immunosuppressants (azathioprine; mycophenolate; cyclosporine; cyclophosphamide; tacrolimus), and 3% targeted synthetic DMARDs. The most frequent individual DMARDs were methotrexate (29%), TNF-inhibitors (18%), antimalarials (10%) and rituximab (6%). The vaccines administered were: 78% Pfizer, 16% AstraZeneca, 5% Moderna and 1% other/unknown; 66% of cases received two doses and 34% one dose. Mean time from 1st and 2nd dose to case report was 41 days (SD 26) and 26 days (SD 23), respectively. COVID-19 diagnosis after vaccination was reported in 1% (18/1519) of cases. Mean time from first vaccination until COVID-19 diagnosis was 24 days (SD 17). Disease flares were reported by 5% (73/1375) of patients with inflammatory RMDs, with 1.2% (17/1375) classified as severe flares. Mean time from closest vaccination date to inflammatory RMD flare was 5 days (SD 5). The most common flare types were arthritis (35/1375=2.5%), arthralgia (29/1375=2.1%), cutaneous flare (11/1375=0.8%) and increase in fatigue (11/1375=0.8%). Potential vaccine side effects were reported by 31% of patients (467/1519). The majority were typical early adverse events within 7 days of vaccination, namely pain at the site of injection (281/1519=19%), fatigue (171/1519=11%) and headache (103/1519=7%). Organ/system adverse events were reported by 2% (33/1519) but only 0.1% (2/1519) reported severe adverse events, namely a case of hemiparesis in a patient with systemic sclerosis/SLE overlap syndrome (ongoing at the time of reporting), and a case of giant cell arteritis in a patient with osteoarthritis (recovered/resolved without sequelae). Conclusion The safety profiles for COVID-19 vaccines in RMD patients was reassuring. Most adverse events were the same as in the general population, they were non-serious and involved short term local and systemic symptoms. The overwhelming majority of patients tolerated their vaccination well with rare reports of inflammatory RMD flare (5%; 1.2% severe) and very rare reports of severe adverse events (0.1%). These initial findings should provide reassurance to rheumatologists and vaccine recipients, and promote confidence in COVID-19 vaccine safety in RMD patients, namely those with inflammatory RMDs and/or taking treatments that influence their immune system. Acknowledgements EULAR COVID-19 Task Force; European Reference Network on rare and Complex Connective Tissue and Musculoskeletal Diseases; European Reference Network on Rare Immunodeficiency, Autoinflammatory and Autoimmune Diseases Network; all rheumatologists contributing to the EULAR COVAX Registry. Disclosure of Interests Pedro M Machado Consultant of: Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript., Grant/research support from: Orphazyme, unrelated to this manuscript., Speakers bureau: Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript., Saskia Lawson-Tovey: None declared, Kimme Hyrich Grant/research support from: BMS, UCB, and Pfizer, all unrelated to this manuscript., Speakers bureau: Abbvie, Loreto Carmona Consultant of: her institute works by contract for laboratories among other institutions, such as Abbvie Spain, Eisai, Gebro Pharma, Merck Sharp & Dohme España, S.A., Novartis Farmaceutica, Pfizer, Roche Farma, Sanofi Aventis, Astellas Pharma, Actelion Pharmaceuticals España, Grünenthal GmbH, and UCB Pharma, all unrelated to this manuscript., Laure Gossec Grant/research support from: AbbVie, Amgen, BMS, Biogen, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, all unrelated to this manuscript., Speakers bureau: Amgen, Lilly, Janssen, Pfizer, Sandoz, Sanofi, Galapagos, all unrelated to this manuscript., Elsa Mateus Grant/research support from: LPCDR received support for specific activities: grants from Abbvie, Novartis, Janssen-Cilag, Lilly Portugal, Sanofi, Grünenthal S.A., MSD, Celgene, Medac, Pharmakern, GAfPA; grants and non-financial support from Pfizer; non-financial support from Grünenthal GmbH, outside the submitted work., Anja Strangfeld Speakers bureau: AbbVie, MSD, Roche, BMS, and Pfizer, all unrelated with this manuscript., BERND RAFFEINER: None declared, Tiphaine Goulenok: None declared, Olilvier Brocq: None declared, Martina Cornalba: None declared, José A Gómez-Puerta Speakers bureau: AbbVie, BMS, GSK, Janssen, Lilly, MSD, Roche and Sanofi., Eric Veillard: None declared, Ludovic Trefond: None declared, Jacques-Eric Gottenberg: None declared, Julien Henry: None declared, Patrick Durez: None declared, Gerd Rüdiger Burmester: None declared, Marta Mosca: None declared, Eric Hachulla: None declared, Hans Bijlsma: None declared, Iain McInnes: None declared, Xavier Mariette Consultant of: BMS, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sanofi-Aventis, UCB, and grant from Ose, all unrelated to this manuscript.
Article
Objective To develop guidance on the use of COVID-19 vaccines in patients with autoimmune rheumatic diseases (ARD). Methods The Canadian Rheumatology Association (CRA) formed a multidisciplinary panel including rheumatologists, researchers, methodologists, vaccine experts and patients. The panel used the GRADE approach. Outcomes were prioritized according to their importance for patients and clinicians. Evidence from the COVID-19 clinical trials was summarized. Indirect evidence for non-COVID-19 vaccines in ARD was also considered. The GRADE Evidence-to-Decision (EtD) framework was used to develop a recommendation for the use of the four COVID vaccines approved in Canada as of March 25, 2021 (BNT162b2, mRNA-1273, ChAdOx1 and Ad26.COV2.S) over four virtual panel meetings. Results The CRA guideline panel suggests using COVID-19 vaccination in persons with ARD. The panel unanimously agreed that for the majority of patients the potential health benefits of vaccination outweigh the potential harms in people with ARDs. The recommendation was graded as conditional because of low or very low certainty of the evidence about the effects in the population of interest primarily due to indirectness and imprecise effect estimates. The panel felt strongly that persons with autoimmune rheumatic diseases who meet local eligibility should not be required to take additional steps compared to people without autoimmune rheumatic diseases to obtain their vaccination. Guidance on medications, implementation, monitoring of vaccine uptake and research priorities are also provided. Conclusion This recommendation will be updated over time as new evidence emerges, with the latest recommendation, evidence summaries and EtD available on the CRA website.