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Of the 217 assessments 109 were in SCCAI defined remis-
sion, 95 were in PRO2 defined remission and the two were
highly contingent (p<0.0001). The sensitivity and specificity
of disease activity assessments made with PRO2 vs SCCAI
were 0.85 and 0.98, respectively. The positive and negative
predictive values were 0.98 and 0.87, respectively.
Conclusions The PRO2 performs well when validated against
an established clinical disease activity index (SCCAI), quality
of life assessments and biochemical markers of disease activity.
PRO2 assessments have the benefit of being more rapid to
administer (comprising of only 2 items) than SCCAI (6 items),
whilst providing similar and accurate evaluations of remission
status.
P144 THERAPEUTIC THRESHOLDS FOR GOLIMUMAB SERUM
CONCENTRATIONS DURING INDUCTION AND
MAINTENANCE: RESULTS FROM THE GO-LEVEL STUDY
Mark Samaan*, Georgina Cunningham, Gokul Tamilarasan, Krystal Rawstron,
Karim Hawash, Luisa Beltran, Shuvra Ray, Joel Mawdsley, Simon Anderson,
Jeremy Sanderson, Zehra Arkir, Peter Irving. Guy’s and St Thomas’Hospital, London, UK
10.1136/gutjnl-2020-bsgcampus.219
Introduction The exposure-response relationship associated
with the use of golimumab for UC was demonstrated in the
PURSUIT trial. Significant associations between serum golimu-
mab concentrations (SGC) and favourable outcomes were
observed during both induction and maintenance therapy.
However, data regarding the optimal therapeutic SGC thresh-
old is limited and therefore, recent AGA guidance made no
recommendation in this regard.
Methods GO-LEVEL was an open label, phase IV, investigator-
initiated study (NCT03124121) which included a prospective
cohort of UC patients commencing golimumab induction ther-
apy, as well as a cross-sectional cohort receiving maintenance
treatment (>18 weeks from initiation).
Patients commencing induction all had disease activity
objectively confirmed and were evaluated at weeks 6, 10 and
14. Patients receiving maintenance therapy were recruited
either at the point of flare, or during stable remission. Clinical
disease activity was evaluated using SCCAI and PRO2, and
biochemical activity using FC and CRP. Combined clinical-bio-
chemical remission was defined as SCCAI less than 3 and FC
less than 250 ug/g.
SGC and anti-golimumab antibodies (ADA) were measured
using a drug sensitive ELISA (LISATRACKER, Theradiag).
Mann-Whitney U was used to compare groups, ROC curve
analysis to identify therapeutic thresholds, Spearman’s rank
coefficient (r
s
) for correlations and Cochrane-Armitage test for
quartile data.
Results Thirty-nine patients were included in the induction
cohort, of whom 15 (38%) achieved combined remission at
week 6. The median SGC of those in combined remission
was significantly higher than those who were not (5.0 vs 3.1
ug/ml, respectively, p=0.03). ROC curve analysis demonstrates
3.8 ug/ml as the optimal therapeutic threshold to achieve
combined remission at week 6 (sensitivity 0.71, specificity
0.65, AUC 0.72). Significant, inverse correlations were
observed between week 6 SGC and PRO2, CRP and FC (r
s
-
0.41 (p=0.01), -0.47 (p=0.004) and -0.40 (p=0.02),
respectively).
Sixty-four patients were included in the maintenance
cohort; 32 (50%) were in combined remission, 32 were not.
The median SGC of those in combined remission was signifi-
cantly higher (3.0 vs 2.1 ug/ml, respectively, p=0.003). ROC
curve analysis demonstrates 2.4 ug/ml as the optimal therapeu-
tic threshold to achieve combined remission (sensitivity 0.73,
specificity 0.66, AUC 0.71).
SGC quartile analyses (figure 1) demonstrated significant
trends to higher rates of combined remission with greater
exposure during both induction (p=0.01) and maintenance
(p=0.01).
No AGA were detected in either cohort.
Conclusions GO-LEVEL offers further evidence of the expo-
sure-response relationship with golimumab. Clinicians may
consider using therapeutic drug monitoring to optimise goli-
mumab dosing aiming to achieve our suggested SGC therapeu-
tic thresholds of 3.8 ug/ml at week 6 and 2.4 ug/ml during
maintenance.
P145 BIOLOGICS ARE INFERIOR TO SURGERY IN ISOLATED
INTERNAL PENETRATING CROHN’S DISEASE: A SINGLE
CENTRE EXPERIENCE
1
Gregory Sebepos-Rogers*,
2
Nader Al-Shakarchi,
2
Tanvi Khetan,
1
Sara McCartney,
1
Stuart Bloom,
1
Edward Seward,
1
Roser Vega,
1
Farooq Rahman,
1
Shameer Mehta.
1
University College Hospital, Department of Gastroenterology, London, UK;
2
University
College London, School of Medicine, London, UK
10.1136/gutjnl-2020-bsgcampus.220
Introduction 50% of patents with Crohn’s disease (CD)
develop fistulae, resulting in significant morbidity. Isolated
internal penetrating CD (IPCD), without enterocutaneous man-
ifestations, is the second most prevalent fistulating phenotype
after perianal CD(Schwartz et al., 2019) yet the management
Abstract P144 Figure 1 SGC quartile analyses at week 6 during
induction (left panel) and during maintenance therapy (right panel)
Abstracts
Gut 2021;70(Suppl 1):A1–A262 A117
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of isolated IPCD remains poorly characterised in therapeutic
trials. This study aims to assess outcomes of IPCD at a large,
tertiary IBD centre.
Methods All adult patients with penetrating CD were screened
from imaging reports and corroborated with radiology meet-
ing, surgical and biologic databases between January 2016 and
April 2019. Concurrent perianal or enterocutaneous fistulation
was excluded from analysis. Complete, partial or no resolution
of fistula was an assessed composite of imaging, symptoms
and nutritional independence(Samimi et al., 2010). Statistics:
categorical variables, Fisher’s exact.
Results 29 patients had IPCD diagnosed between 2008 and
2018. 28% had undergone prior gastrointestinal surgery. At
fistula diagnosis, 41% had prior biologic exposure including 6
on their third line biologic, and 66% on a previous or current
immunomodulator. Only 4 (14%) were on a current biologic.
IPCD was diagnosed at median 62 months [IQR 24–117]
after IBD diagnosis with the majority enterocolonic (47%) and
enteroenteric (27%) in configuration. 69% had documented
distal obstruction or stenosis, 7% had a confirmed abscess.
52%, 24% and 24% underwent medical, surgical or no
additional intervention, respectively, as primary management of
their IPCD. Compared with no intervention, only the presence
of symptoms was predictive of medical (14% vs 93%,
p=0.0006) or surgical (14% vs 100%, p=0.0047) interven-
tion, whereas prior surgery, current or prior biologic therapy,
IPCD configuration were not. Of medically treated IPCD,
73% (11/15) had a biologic at median duration 29 months
with Adalimumab 1st line in 64% (7/11) and Ustekinumab
2nd line in 67% (4/6).
There was a trend to greater complete or partial fistula res-
olution by surgery versus medical management (86% (6/7) vs
47% (7/15), p=0.1649) and surgery versus biologics (86% (6/
7) vs 64% (7/11), p=0.596) at reassessment interval (17 [12–
43] vs 8 [7–17] months, respectively) (figure 1). Of medical
and no intervention cohorts, 53% and 29% eventually had
surgery at median intervals 6 and 72 months.
Of the whole cohort, 59% had surgery, in whom 35% had
a pre-operative biologic, 12% pre-operative parenteral nutri-
tion (PN), 18% post-operative PN (duration 14, 41, 8 months
respectively), and 18% post-operative intra-abdominal septic
complications within 30 days.
Conclusion Most patients in this cohort require surgery to
achieve complete of resolution of IPCD with medical therapy
including biologics offering limited temporising effect. For
those predominantly asymptomatic patients, no intervention
can be a suitable management option.
P146 PROVISION OF CARE FOR PREGNANT WOMEN WITH
IBD IN THE UK –THE CURRENT LANDSCAPE
Emma Moore, Sarah Wolloff, Tracey Glanville, Christian Selinger*. Leeds Teaching Hospitals
Nhs Trust, Leeds, UK
10.1136/gutjnl-2020-bsgcampus.221
Introduction Inflammatory Bowel Disease (IBD) results in
increased rates of negative pregnancy outcomes; particularly in
poorly controlled disease. We aimed to describe the current
landscape of provision of antenatal care for women with IBD
in the UK.
Methods This cross-sectional study collected data on service
set-up, on principles of care pre, during, and after pregnancy
and on perceived responsibilities of clinicians. An online sur-
vey was distributed to all gastroenterology units in the United
Kingdom.
Results Data were provided for 97 of 273 IBD units. Pre-
pregnancy counselling was not available in 7%, offered rou-
tinely (39%), or on request (54%) but predominantly (91%)
in an ad-hoc fashion rather than in a dedicated set-up. 92%
of units provided a nominated gastroenterology consultant
during pregnancy. In 86% of this was the patient’s usual con-
sultant rather than a consultant with expertise in pregnancy
(14%).
Combined clinics with obstetricians and gastroenterologists
were offered in 14% of units only, but more often in aca-
demic rather than district hospitals (24% versus 7%;
p=0.043) Otherwise, communication with obstetrics was ‘as
and when required’in 51% of cases. Patients were reviewed
either every trimester (55%), monthly (15%) or ‘only when
required’(30%).
The majority of respondents thought gastroenterologists
should be involved in decisions regarding routine vaccinations
(70%), breastfeeding (80%), folic acid dosage (61%), and VTE
prophylaxis (53%). 65% of participants thought that gastroen-
terologists should be involved in decision-making regarding
delivery method. Regarding IBD indications for elective caesar-
ean section 94% of participants recommended these for active
peri-anal disease, 30% for previous but healed peri-anal dis-
ease, 56% for ileo-anal pouch and 20% for previous abdomi-
nal and/or pelvic surgery.
Conclusion In a nationwide survey on the provision of antena-
tal IBD care we found considerable variation in all aspects of
service provision, particularly the availability of expertise and
specialist services. We have detected areas of poor care
(review only when required, communication ad-hoc only, poor
provision of dedicated pre-pregnancy counselling). A significant
minority of IBD units also felt that they do not need to
Abstract P145 Figure 1 Categorisation of intervention decision-
making of IPCD by A. Key patient characteristics, B. Outcome at
reassessment
Abstracts
A118 Gut 2021;70(Suppl 1):A1–A262
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