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Biologic treatment of inflammatory bowel disease in Poland, 2012–2020: nationwide data

  • Maria Skłodowska-Curie National Research Institute of Oncology


Introduction: The frequency of biologic drug treatment for Polish patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) has been partly assessed. Objectives: We aim to analyze the use of biologic treatments among Polish patients suffering from IBDs. Patients and methods: We used administrative data collected by the National Health Fund (NFZ), Poland's sole public payer. IBD cases were defined as cases with ≥2 records assigned code K50 or K51 and either ≥2 reimbursed prescriptions for IBD drugs or intestinal surgery preceding the record. We identified IBD patients receiving biologic treatments reimbursed by the NFZ in the years 2012-2020. We assessed the percentages of patients receiving biologic treatments in terms of disease type, gender, age group, and place of residence. Results: While 6.8% of Poland's CD patients received biologic treatment in 2012, that figure reached 7.9% by 2020. Biologic treatments were given to 0.4% of UC patients in 2014, compared to 1.6% in 2020. Among patients with both CD and UC, significantly fewer women received biologic therapy than men. The highest percentages of patients receiving biologic treatment for CD and UC were observed in the 10-19 age group, while adults over 70 had the lowest percentage. Conclusions: We show a growing use of biologic agents in the treatment of IBD in Poland. Women receive biologic treatment for IBD significantly less frequently than men. The pediatric population features the highest proportion of patients receiving such treatment.
ORIGINAL ARTICLE Biologic treatment of inflammatory bowel disease in Poland 1
aseries of ileitis cases later classified as CD, long
before thefirst detailed description (1932) of a
patients’ series by BB Crohn and his collabora
eetiology of both diseases remains un
clear, though thesuspected contributing factors
include genetic predispositions, changes in im
mune system functioning, and environmental
Both diseases are chronic in nature but
with periods of relapse alternating with remis
sions; and both tend to develop complications,
including some extraintestinal manifestations.
eprevalence of IBD is increasing steadily
across theworld. According to eGlobal Burden
of Diseases, Injuries and Risk Factors Study,7 there
INTRODUCTION Disclaimer: For thepurpose
of this work, theauthors use theterm “biolog
ic drugs” to denote any of theinnovative drugs
used in thetreatment of inflammatory bowel dis
ease (IBD), including infliximab, adalimumab, ve
dolizumab, ustekinumab, and tofacitinib. Strict‑
ly speaking, tofacitinib is not abiologic drug but
treating it as one fits best with thegovernmental
therapeutic programs being pursued in Poland.
Crohn disease (CD) and ulcerative colitis (UC)
are brought together under thegeneral heading
of IBD. While thefirst case of UC was described in
1859 by Sir Samuel Wilks, it was a Polish surgeon
Antoni Leśniowski who in 1903 first reported
Biologic treatment of inflammatory bowel
disease in Poland, 2012–2020: nationwide data
, EdytaZagórowicz
, DorotaWalkiewicz
, JakubPerwieniec
, PaulinaWieszczy
, JarosławReguła
1 Department of Oncological Gastroenterology, Maria Sklodowska ‑Curie National Research Institute of Oncology, Warsaw, Poland
2 Department of Gastroenterology, Hepatology, and Clinical Oncology, Center of Postgraduate Medical Education, Warsaw, Poland
3 Department of Analyses and Strategies, Ministry of Health in Poland, Warsaw, Poland
4  Department of Adult Neurology, Medical University of Gdansk and University Clinical Center, Gdańsk, Poland
5 Clinical Effectiveness Research Group, Institute of Health and Society, Oslo University, Oslo, Norway
Correspondence to:
Piotr Kucha, MD, Department
of Oncological Gastroenterology,
Maria Sklodowska‑Curie National
Research Institute of Oncology,
ul. Roentgena 5, 02‑871 Warszawa,
Poland, phone: +48 225 46 23 28,
Received: March 28, 2022.
Revision accepted: June 27, 2022.
Published online: July 4, 2022.
Pol Arch Intern Med. 2022;
132 (7‑8): 16287
Copyright by the Author(s), 2022
* PK and EZ contributed equally to
this work.
biologic treatment,
inflammatory bowel
disease, population
INTRODUCTION The frequency of biologic drug treatment for Polish patients diagnosed with ulcerative
colitis (UC) or Crohn disease (CD) has been insufficiently studied.
OBJECTIVES We aimed to analyze the use of biologic treatments among Polish patients suffering from
inflammatory bowel diseases (IBDs).
We used administrative data collected by the National Health Fund (Narodowy
Fundusz Zdrowia [NFZ]), Poland’s sole public health care payer. IBD cases were defined as cases with
at least 2 records assigned code K50 or K51 according to the International Statistical Classification of
Diseases and Related Health Problems, Tenth Revision (ICD ‑10) and either at least 2 reimbursed pre
scriptions for IBD drugs or intestinal surgery preceding the record. We identified IBD patients receiving
biologic treatments reimbursed by the NFZ in the years 2012–2020. We assessed the percentages of
patients receiving biologic treatments in terms of disease type, sex, age group, and place of residence.
While 6.8% of Polish CD patients received biologic treatment in 2012, that figure reached
7.9% by 2020. Biologic treatments were given to 0.4% of UC patients in 2014, and 1.6% in 2020. Among
patients with both CD and UC, significantly fewer women received biologic therapy than men. The highest
percentages of patients receiving biologic treatment for CD and UC were found in the 10–19 age group,
while patients over 70 were the adults most rarely treated with biologic drugs.
CONCLUSIONS We showed a growing use of biologic agents in the treatment of IBD in Poland. Women
receive biologic treatment for IBD significantly less frequently than men. The pediatric population features
the highest proportion of patients receiving such treatment.
by Myrelid and
2022; 132 (7-8)
Activity Index (CDAI) scale, or over 50 points
on thePediatrics Crohn Disease Activity Index
(PCDAI) scale and aprevious failure of aconven
tional therapy, for example, glucocorticoids or im
munosuppressive drugs. In thecase of ustekinum
ab, anadditional condition is theexclusion of
anti ‑tumor necrosis factor (TNF) as afirst ‑line
biologic medicine, due to its proven prior fail
ure. In thepresence of aperianal fistula, inflix
imab or adalimumab may be used irrespective of
theCDAI or PCDAI score.13
ecurrent therapeutic B.55 program “e
treatment of patients with ulcerative colitis” pro
vides thetreatment for patients aged 6 and over
with infliximab, as well as with vedolizumab, to‑
facitinib, or ustekinumab for patients aged 18 and
over. ecriteria to be met by patients in this con
text are: amoderate to severe flare of thedisease
defined as 6 or more points on theMayo scale
for adults, and 65 or more points on thePediat‑
ric Ulcerative Colitis Activity Index scale for pa‑
tients aged 6–18, including aprevious failure of
theconventional therapy, or counterindications
where its use is concerned, with simultaneous
counterindications as regards theadministra
tion of cyclosporine.14
Until 2022, thetreatments available in both
therapeutic programs were time ‑limited, that is,
could be administered for 12 to 24 months. In
their latest versions (applicable from 2022 and be
yond), thetime limits have ceased to be imposed.
eanalysis of such NFZ ‑reimbursed usage of
biologic treatment among Polish patients with
the2 types of IBD represented both theaim and
thesubject matter of theresearch detailed in this
Our anal
ysis centered on administrative health care–re
lated claims in Poland, collected in thedatabases
of theNFZ, thesole entire state health care pay
er. We searched therecords for health services
taking theform of individual claims reported to
theNFZ by theservice providers. einitial as‑
sessment concerned theprevalence of IBD in Po
land in theyears 2012–2020, with reference to
theprevalent and incident cases in theNFZ da‑
tabase assigned aK50 or K51 code according to
theInternational Statistical Classification of Dis-
eases and Related Health Problems, Tenth Revi-
sion (ICD ‑10).8 Due to alack of electronic data,
there was no possibility of assessing thepreva
lence of IBD for theyears 2008–2011, aperiod in
which theCD therapeutic program was already
active. In thenext step, we calculated therates
of thetherapeutic program treatment in CD and
UC patients with reference to age, sex, and place
of residence. We further looked for anassocia
tion between theuse of biologic drugs in dif
ferent regions of Poland (voivodeships), as set
against thenumber of gastroenterologists prac
ticing in each region. elatter data for individ
ual years were obtained from thePolish Cham
ber of Physicians and Dentists.
were 6.8 million people living with IBD in2017. In
2020, Poland reported 23 574 patients diagnosed
with CD, as well as 73 235 with UC,8 out of ana‑
tional population of some 38 million inhabitants.
Given thelack of clarity as to thecause(s)
of IBD, there is no causative treatment. Rath
er, themanagement of IBD includes theuse of
5 ‑aminosalicylates, budesonide, systemic ste
roids, immunosuppressive agents (azathioprine,
6 ‑mercaptopurine), and thenewest therapeutic
innovations: biologic drugs and small ‑molecule
immunosuppressive drugs. Two treatment ap
proaches have been implemented into clinical
practice: a“step ‑up” one, whereby theintroduc‑
tion of biologic drugs follows afailure of acon‑
ventional therapy, and a“top ‑down” approach in
which biologic drugs represent afirst‑line thera‑
py. So far there has been no strong evidence fa‑
voring one over another,9-12 however, a majority
of gastroenterological associations recommend
the“step ‑up” strategy as astandard approach
in moderate to severe disease course, limiting
theuse of the“top ‑down” one to patients with
poor prognosis on thedisease onset.
Today, in theEuropean Union, and so also in
Poland, there are 5 innovative drugs registered
for use in IBD treatment: infliximab, adalimum‑
ab, vedolizumab, ustekinumab, and tofacitinib.
In Poland, due to thehigh costs of treatment
with innovative drugs, theabovementioned med
ications are fully reimbursed by theNational
Health Fund (Narodowy Fundusz Zdrowia [NFZ])
through so ‑called therapeutic programs approved
by theMinistry of Health. etherapeutic pro‑
gram for CD (B.32)13 was established in Novem‑
ber 2007; its counterpart for UC (B.55)
was es‑
tablished in October2013. Both have undergone
many changes, most significantly, extensions of
maximum treatment duration and introduction
of new drugs.
ecurrent B.32 therapeutic program “e
treatment of patients with Crohn disease” makes
infliximab or adalimumab available for use in pa
tients aged 6 years and above, while vedolizumab
or ustekinumab can be used in those of atleast
18 years of age. Criteria to be met by thepatients
are: asevere flare of thedisease defined by ascore
of more than 300 points on theCrohn Disease
To the best of our knowledge, this article is the first to describe the popula
tion of Polish patients suffering from inflammatory bowel diseases (IBDs) and
treated with innovative biologic drugs, which are the best treatment options
known for patients with a moderate to severe disease course. Using admin
istrative data, we estimated and discussed significant differences in the use
of biologic drugs across different regions of Poland. We also showed a higher
treatment rate for men than for women, as well as a high and rising rate for
the youngest population. Access to modern therapies is crucial for improving
the quality of life for the substantially growing population of IBD patients. We
believe our work will be a helpful reference for evaluating the current situation
of those patients and for predicting future demands.
ORIGINAL ARTICLE Biologic treatment of inflammatory bowel disease in Poland 3
outside that voivodeship and, 2) the number of
patients residing in a given voivodeship treated
in another one. All these migration rates were
calculated for 2020.
Statistical analysis
eprescription rates for
biologic therapies for CD in Poland in agiven
year between 2012 and 2020 were calculated as
thenumber of patients registered in thethera
peutic program for CD, as divided by 100 preva
lent CD cases. Ananalogous process was run for
UC. However, as biologic therapies for UC had
not been reimbursed before 2014, we calculat
ed therates for the2014–2020 period only. Dif
ferences in rates for women and men were com
pared using theχ
test, while voivodeship ‑based
relationships between thenumber of gastroen
terologists and therates of patients participat
ing in biologic therapy were assessed by calcu
lating thePearson correlation coefficients using
R statistical software (version 3.6.2) (R Founda
tion for Statistical Computing, Vienna, Austria)
with the“data.table” package (version 1.12.8).
All the tests were 2 ‑sided and significance level
was set ata P value of 0.05.
Ethical Committee estudy representing theba
sis for this paper gained approval from theBio‑
ethical Committee of theMaria Sklodowska‑
‑Curie National Research Institute of Oncolo
gy (73/2021).
RESULT S Crohn disease eofficial number of
CD patients in Poland rose from 11 107 in 2012
to 23 574 in2020. erates of biologic drug use
among these patients in theyears 2012–2020 are
presented in
. As many as 751 patients with
CD received biologic treatment in 2012, consti‑
tuting 6.8% of their total number (751/11 107).
enumber of such patients in 2020 was 1863,
representing 7.9% of thetotal number. us, even
though theabsolute numbers of CD patients re‑
ceiving biologic drugs in theanalyzed period dou
bled, theproportion of prevalent CD patients
treated with biologic drugs increased only slight
ly (TABLE 1).
For most of theanalyzed years, there was asig
nificant difference in thefrequency of using bi‑
ologic drugs in men and women. In 2012, 6.4%
of women diagnosed with CD were registered in
thetherapeutic program, as compared with 7.2%
of men (
). In 2020, thedifference was more
pronounced, with respective rates of 6.7% and
9.0% (P<0.001).
Over theanalyzed period as awhole, thegroup
of patients with CD showing thehighest frequen
cy of treatment with biologic drugs were those
aged 10–19 years. Furthermore, it was in this
group that themost marked increase in theshare
of patients receiving biologic treatment was re‑
corded (from 11.8% in 2012 to 21.7% in 2020)
(FIGURE 1; Supplementary material, Table S4).
enumber of hospitals offering biologic treat
ment for CD increased from 53 in 2012 to 62
Biologic drug therapies for Crohn disease and ulcer-
ative colitis
Services associated with thebiologic
treatment of CD or UC were identified in theNFZ
service database with relation to specific products
covered by theNFZ contracts (Supplementary ma
terial, Table S1). Each patient receiving atleast 1
service over the2012–2020 period was identified
and assigned to aspecific voivodeship in line with
thelocation of thehospital involved and not their
place of residence. epatients treated in more
than 1 voivodeship in agiven year were assigned
to each voivodeship involved.
Prevalence of Crohn disease and ulcerative colitis As
abasis for calculating thepercentage of patients
receiving thebiologic drugs for CD or UC, we used
therespective prevalence for these diseases, as
estimated previously.
epatients were select
ed based on thefollowing criteria: 1) atleast 2
services in ahospital, or anoutpatient specialist
clinic, reported with theK50 or K51 ICD ‑10 code,
and either 2) atleast 2 prescriptions filled out for
IBD drugs (as listed in Supplementary material,
Table S2) with aninterval of atleast 2 months, or
3) anepisode of intestinal surgery assigned 1 of
thedefined International Classification of Diseas-
es, Ninth Revision codes (Supplementary materi‑
al, Table S3), prior to atleast 1 service reported
with K50 or K51 ICD ‑10 codes.
enext step classified thepatients as suf
fering from either CD or UC, on thebasis of
theICD ‑10 code reported for thelast service
received, so that each patient was assigned to
thegroup with CD, UC, or both of these diagnoses.
Migration analysis
To assess theuse of thebiolog
ic drugs in individual voivodeships and thescale of
patient migration, we calculated thepercentage of
patients who could be regarded as external to each
of the16 voivodeships in Poland. We also calcu‑
lated thepercentage of residing patients treated
in other voivodeships and themigration balance,
defined as thedifference between 1) the number
of patients treated in a given voivodeship residing
TABLE 1 Percentage of Crohn disease patients treated under B.32 therapeutic
program in Poland in the years 2012–2020
Year Number of CD
patients treated with
biologic drugs
Total number of CD
Rate of use of
biologic drugs per
100 cases
2012 751 11 107 6.8
2013 863 13 022 6.6
2014 1084 14 953 7.2
2015 1239 16 784 7.4
2016 1312 18 477 7.1
2017 1454 20 125 7.2
2018 1663 21 712 7.7
2019 1823 23 058 7.9
2020 1863 23 574 7.9
Abbreviations: CD, Crohn disease
2022; 132 (7-8)
of their voivodeship of residence, atfrequency
up to 88.6%. is means that, roughly speaking,
only 1 in 10 CD patients from Lubuskie voivode‑
ship received biologic treatment close to their
place of residence.
Ulcerative colitis
enumber of UC patients in
Poland increased from 49 758 in 2014 to 73 235
in2020. erates of biologic drugs usage among
these patients in theyears 2014–2020 are pre
sented in TABLE 3. ere were 207 UC patients
treated with biologic drugs in 2014, which was
just 0.4% of thetotal number (207/49 758).
In 2020, these numbers rose to 1174 and 1.6%
(1174/73 235), respectively; both absolute and
relative numbers of UC patients on biolog
ic drugs were markedly higher than in 2014
(TABLE 3).
As with CD, we witnessed asignificant differ‑
ence in theuse of these drugs between men and
in2020. In 2020, thehighest number of such
centers was 10 noted for Mazowieckie voivode
ship, whereas both Opolskie and Świętokrzyskie
voivodeships had only 1 such center. FIGURE 2 and
Supplementary material, Table S5 present shares
of patients with CD receiving biologic drugs in
2020 per voivodeship. Substantial differences are
to be noted. In Mazowieckie voivodeship (that in
cludes Warsaw, thecapital of Poland), 13.8% of all
patients with CD received treatment with biologic
drugs—a sharp contrast with Lubuskie voivode‑
ship, for which therate was as low as 1.2%. It fur
ther emerged that Mazowieckie was theregion of
Poland treating thehighest percentage of patients
from other voivodeships. epatients treated in
Mazowieckie but residing in other voivodeships
accounted for 34.9% of all patients treated with
biologic drugs in this voivodeship. Conversely,
Lubuskie voivodeship had thehighest percentage
of patients receiving biologic treatment outside
TABLE 2 Treatment rates for men and women with Crohn disease under B.32 therapeutic program in Poland in the years 2012–2020
Year Women with
CD under B.32
Men with CD
under B.32
Total number of
women with CD
Total number of
men with CD
Percentage of
women under
B.32 program
Percentage of
men under B.32
P value
2012 363 388 5683 5424 6.4 7.2 0.11
2013 406 457 6638 6384 6.1 7.2 0.02
2014 489 595 7562 7391 6.5 8.1 <0.001
2015 557 682 8505 8279 6.5 8.2 <0.001
2016 563 749 9309 9168 6 8.2 <0.001
2017 624 830 10 100 10 025 6.2 8.3 <0.001
2018 716 947 10 876 10 836 6.6 8.7 <0.001
2019 777 1046 11 529 11 529 6.7 9.1 <0.001
2020 790 1073 11 713 11 861 6.7 9 <0.001
Abbreviations: see TABLE 1
FIGURE 1 Percentage
of patients with Crohn
disease treated under
B.32 therapeutic program
in the years 2012–2020,
by age group
2012 2013 2014 2015 2016 2017 2018 2019 2020
<10 y
10–19 y
20–29 y
30–39 y
40–49 y
50–59 y
60–69 y
70 y
ORIGINAL ARTICLE Biologic treatment of inflammatory bowel disease in Poland 5
In theyears 2014–2016, thehighest share of
UC patients receiving innovative drugs were those
in their twenties (0.9%). By 2017, however, that
lead position had been taken by thepatients aged
10–19 (
; Supplementary material, Table S6).
women. In 2014, therate for patients diagnosed
with UC was 0.3% for women and 0.5% for men.
By 2020, thedifference was even greater, with
rates for women and men reaching 1.4% and 1.8%,
respectively (P<0.001) (TABLE 4).
TABLE 4 Treatment rates for men and women with ulcerative colitis under B.55 therapeutic program in Poland in
the years 2014–2020a
Year Women Men Number of
with UC
Number of
men with UC
Percentage of
treated under
B.55 program
of affected
men treated
under B.55
P value
2014 82 125 24 607 25 151 0.3 0.5 0.005
2015 124 174 27 182 27 823 0.5 0.6 0.007
2016 99 152 29 500 30 424 0.3 0.5 0.002
2017 166 241 31 730 32 738 0.5 0.7 0.001
2018 287 405 33 658 34 888 0.9 1.2 <0.001
2019 443 578 35 338 36 742 1.3 1.6 <0.001
2020 509 665 35 964 37 271 1.4 1.8 <0.001
a Therapeutic program B.55 was initiated in 2014
Abbreviations: see TABLE 2
TABLE 3 Percentages of patients with ulcerative colitis treated under B.55 therapeutic program in Poland in
the years 2014–2020a
Year Number of UC patients
treated with biologic drugs
Total number of UC patients Rate of use of biologic drugs per
100 cases
2014 207 49 758 0.4
2015 298 55 005 0.5
2016 251 59 924 0.4
2017 407 64 468 0.6
2018 692 68 546 1
2019 1021 72 080 1.4
2020 1174 73 235 1.6
a The therapeutic program B.55 commenced in 2014
Abbreviations: UC, ulcerative colitis
FIGURE 2 Percentage of patients with Crohn disease treated under B.32 therapeutic program in 2020, by Polish
2022; 132 (7-8)
region’s absolute figure of just 5 patients with UC
undergoing biologic treatments. However, as with
CD, Lubuskie voivodeship emerged as thePolish
region from which thehighest proportion (93.1%)
of UC patients sought treatment in avoivodeship
other than their own.
Relations between the number of gastroenterologists
in a voivodeship and the use of biologic drugs
ing the2012–2020 period, thenumber of certi‑
fied gastroenterologists in Poland increased from
713 to1136. Two of theregions boasting thehigh
est number of gastroenterologists per inhabit
ant were Mazowieckie and Podlaskie voivode
ships (each with 4.2/100 000 in 2020). is ra
tio was thelowest in Świętokrzyskie voivode
ship (1.6/100 000 in 2020). e2020 ratio of
thenumber of gastroenterologists per 100 IBD
patients proved to be thehighest in Mazowieckie
voivodeship (1.7/100), and thelowest in Lubuskie,
Wielkopolskie, and Świętokrzyskie voivodships
(0.7/100) (Supplementary material, Table S8).
However, no significant correlation was noted
between thenumber of gastroenterologists and
thenumber of patients receiving biologic treat‑
ment in any voivodeship (P = 0.166).
eanalysis detailed here drew on
Poland‑wide data on theusage of biologic drugs
to treat IBD patients, with costs as reimbursed
by theNFZ. It showed agrowing use of biolog
ic drugs over theyears 2012–2020, in terms of
both absolute numbers of treated patients and
shares of all patients in Poland diagnosed with
either CD or UC. Treatment rates increased from
6.8% in 2012 to 7.9% in 2020 among CD patients,
and from 0.4% in 2014 to 1.6% in 2020 within
thepopulation of those suffering from, and treat
ed for, UC. efactors potentially accounting for
this increase include, primarily, growing clini
cians’ confidence in biologics, arising from abet
ter understanding of their modes of action, and
secondly, amounting evidence regarding both
enumber of hospitals offering thebiolog
ic treatment for UC rose from 31 in 2014 to 52
in2020. In 2020, thehighest number of such
centers was 8 noted for Mazowieckie voivode
ship, whereas Opolskie, Świętokrzyskie, and
Warmińsko ‑Mazurskie voivodeships had
only 1 center each. As for CD, we found clear
voivodeship ‑to ‑voivodeship differences in
therates of using biologic treatment (FIGURE 4;
Supplementary material, Table S7). ehighest
percentage of UC patients treated with innova
tive drugs in 2020 was 3.1% and 3.0%, noted for
Świętokrzyskie and Mazowieckie voivodeships, re
spectively. ecorresponding value for both Lu
buskie and Warmińsko ‑Mazurskie voivodeships
was just 0.2%.
ehighest rate for patients with UC receiving
treatment with biologic drugs in avoivodeship
outside of their place of residence was 40% not‑
ed for Warmińsko ‑Mazurskie voivodeship. How
ever, this result is perhaps misleading, given this
FIGURE 4 Percentage of patients with ulcerative colitis treated under B.55 therapeutic
program in 2020, by Polish voivodeships
FIGURE 3 Percentage
of patients with ulcerative
colitis treated under B.55
therapeutic program in
the years 2014–2020, by
age group
<10 y
10–19 y
20–29 y
30–39 y
40–49 y
50–59 y
60–69 y
70 y
2014 2015 2016 2017 2018 2019 2020
ORIGINAL ARTICLE Biologic treatment of inflammatory bowel disease in Poland 7
of biologic drugs in IBD patients of different ages.
ehighest rate of biologics use was found for
thepatients aged 10–19 years, perhaps because
these are theyoungest patients that are more of
ten affected by anaggressive course of thedis
ease. AHungarian population study19 taking 30
years of practice into consideration established
that small intestine involvement, perianal fistu‑
las, aneed for systemic steroids, and aneed for
surgery induced by thedisease all arise more of‑
ten in pediatric CD patients than in adults, while
all of thefactors referred to are associated with
poor outcome prognoses. Moreover, just as in
our study, Romberg ‑Camps et al
that it was within their youngest (under 18 years
old) population of IBD sufferers that thehigh
est cumulative rate of use of biologics (19%) was
to be found.
Our study further showed that men were more
likely than women to be treated with biologic
drugs. Such afinding was in fact made previous‑
ly in amulticenter Polish study on anti TNF use
in therapeutic programs in IBD.
tioned Swedish analysis17 also noted asex ‑based
difference in therate of using thebiologics (sig‑
nificant atP = 0.02).
However, this phenome‑
non has no obvious explanation, given conflict‑
ing data on sex‑related differences in IBD courses
and complications. ere are nevertheless stud‑
ies showing that male sex is arisk factor when it
comes to IBD taking amore severe course, with
this extending, in thecase of CD, to ahigher fre‑
quency of involvement of theupper gastrointes‑
tinal tract and small intestine. ese circumstanc
es may prompt clinicians to make more frequent
use of biologics.20,22,23 According to other studies,
male sex is anindependent risk factor for exten‑
sive abdominal surgery, including intestinal re
It is also worth mentioning that, with
in theIBD population, it is men who most often
go on to suffer—often fatally—from cancer of
thelarge bowel.25,26
Another possible explanation for themore
limited usage of biologic drugs among women
might involve discontinuation of treatment due
to its adverse effects. Some studies suggest that
thefemale sex is anindependent risk factor when
it comes to adverse effects of anti TNF drugs.
Moreover, in thePolish case, pregnancy was acri
terion that straightforwardly excluded thepa
tients from thetherapeutic programs. is was
likely afurther reason why women were treated
with biologic drugs for IBD less often than men.
eremaining significant difference dem
onstrated for therates of using biologics is
theregionally ‑based one, given that as many
as 27% of all instances of biologic therapy for
Polish CD patients involved receipt of thedrugs
inMazowieckie voivodeship. ecorresponding
figure for patients with UC was 24%. Atthe oth‑
er extreme, thewestern voivodship of Lubuskie
emerged as contributing theleast to overall bi
ologic treatment of Polish CD and UC patients.
In 2020, just 0.27% of Polish patients with CD
their effectiveness and safety. Another probable
factor is theintroduction of biosimilar drugs that
lowered thecosts of thetherapy. is was later
accompanied by extensions of maximal periods
of treatment under available treatment programs
that further encouraged thegastroenterologists
to enroll more patients in thehope of achieving
prolonged remission. One more possible reason
for theincreased rate of using thebiologics among
Polish IBD patients may lie in improved access,
with agrowing number of centers offering this
kind of treatment. Finally, thegradual increase in
thenumber of drugs encompassed by therapeutic
programs over thelast 5 years may have allowed
thepatients failing to respond to thefirst ‑line
therapy to re ‑enroll for new treatments.
eobserved increase in theuse of biologics in
Poland resembles thesituation in other countries.
ADanish nationwide study
on enrolled patients
diagnosed with IBD over theyears 2003–2016
found theshare of participants treated with bi‑
ologic agents rising from 0% to 16% for CD, and
from 0% to 5% for UC cases. A2010–2016 Nor‑
wegian study
reported anincrease in therate
of use of biologic drugs from 17% to 33% for CD
patients, and from 7% to 13% for UC patients.
Furthermore, astudy from Sweden,
methodologically similar to ours (and which ana
lyzed thepopulation of IBD patients diagnosed in
theyears 1969–2017, and those treated with bio
logics in theyears 2005–2017), pointed to thecu
mulative rate of use of thedrugs being as high as
14.5% and 6.7% among patients with CD and UC,
respectively. ASwiss study18 noted anincrease
in theuse of biologic drugs among IBD patients
from 5.3% in 2010 to 12.8% in 2014, albeit with
no distinction drawn between CD and UC. Afur
ther limitation of thelatter study was its confine
ment to patients insured by asingle Swiss pay
er, which covered only around 15% of thepopu‑
lation of Switzerland.
While theshare of Polish IBD patients receiving
treatment has been on therise, it remains below
thelevels noted in other countries for which data
have been published. is would mainly seem to
reflect therestrictive rules applied to Polish ther
apeutic programs. In particular, theminimum lev
el thedisease activity required for thetreatment
to commence is simply too high to allow many
patients with moderate activity to be included,
along with those for whom conventional treat
ment has failed and who experience postopera‑
tive relapse. For every patient taken on, there is
anabsolute requirement to establish afailure of
theconventional therapy. is clearly stands in
theway of any early ‑stage introduction of thebi
ologic treatment, despite thefact that thebio
logic therapy is proven to be themost effective.
Moreover, the2 Polish programs were previous‑
ly run under time limits, requiring withdrawal
after 12 or 24 months, even if thetreatment re‑
mained efficient.
Afurther key observation from our study con
cerned significant differences in thedeployment
2022; 132 (7-8)
Supplementary material is available at
FUNDING This work was supported by the European Union via the Euro‑
pean Social Fund and within the framework of the Knowledge ‑Education‑
‑Development Operational Programme (Project entitled, “Maps of Health
Needs – A Database of Systemic and Implementation Analyses”), grant
number POWR.05.02.00 ‑00 ‑0149/15. Language editing was funded by
the Polish Foundation for Gastroenterology.
CONTRIBUTION STATEMENT PK, EZ, and JR initiated the work. PK and
EZ interpreted data and drafted and revised the manuscript. DW and PW
analyzed the data and participated in drafting of the manuscript. JP and
MM participated in the study design and drafting. JR also participated in
the study design, while later being involved in revisions of the manuscript.
All authors have read and accepted the manuscript in its final form, includ‑
ing the authorship list.
CONFLICT OF INTEREST All the authors have provided statements on
financial conflict of interest. DW, JP, MM, and PW declared no such con‑
flict. PK declared support for attendance at meetings from Janssen. EZ de‑
clared support for attendance at meetings or for travel from Takeda and Fer
ring, as well as individual honoraria for consultancy or lectures from BMS,
Takeda, Janssen, Ferring, and Fresenius Kabi. JR declared support for atten‑
dance at meetings or travel from Servier and Alfasigma, as well as individ‑
ual honoraria for consultancy or lectures from Alfasigma, Servier, Janssen,
Takeda, Amgen, and Ipsen.
OPEN ACCESS This is an Open Access article distributed under the terms
of the Creative Commons Attribution‑NonCommercial‑ShareAlike 4.0 Inter‑
national License (CC BY ‑NC ‑SA 4.0), allowing third parties to copy and re‑
distribute the material in any medium or format and to remix, transform, and
build upon the material, provided the original work is properly cited, distrib‑
uted under the same license, and used for noncommercial purposes only. For
commercial use, please contact the journal office at
HOW TO CITE Kucha P, Zagórowicz E , Walkiewicz D, et al. Biologic treat‑
ment of inflammatory bowel disease in Poland, 2012–2020: nationwide
data. Pol Arch Intern Med. 2022; 132: 16287. doi:10.20452/pamw.16287
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13 Appendix B.32. The treatment of patients with Crohn’s disease (ICD ‑10
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treated with biologic drugs were cared for in that
voivodeship. ecorresponding figure for UC was
just 0.34%. ekey reason for this would seem to
involve limited access to specialist gastroenterol
ogy care in many patients’ respective regions of
residence. Data from thePolish Chamber of Phy
sicians and Dentists reveal that, while Mazow
ieckie voivodeship had 226 gastroenterologists
in 2020 (or 1.7 per 100 IBD patients), Lubuskie
voivodship had amere 17 (or 0.7 per 100 IBD pa
tients). Nevertheless, it was not possible to estab
lish any significant correlation between thenum
ber of gastroenterologists in agiven voivodeship
and thenumber of patients treated with biologic
drugs (with P = 0.17).
ese last differences might be partly explained
by migration of IBD patients in search of treat‑
ment, to thehighly ‑specialized centers mainly lo
cated in thecapital and atacademic units. While
there were several dozen centers offering biolog
ic treatment across thecountry as of 2020 (62
for CD and 52 for UC), the5 most ‑utilized ones
served no fewer than 38.3% of thecountry’s CD
patients and 35.1% of thecountry’s UC patients.
Migration balance was thus definitely positive
in thecase of Mazowieckie voivodeship, with al‑
most 35% of CD patients and nearly 26% of UC
patients receiving biologic treatment there com‑
ing from beyond theregion’s borders. Atthe oth
er extreme, in Lubuskie voivodeship, more than
88% of theresident CD patients on biologic drugs
received this treatment in another voivodeship.
In thecase of UC, thefigure was 93.1%.
Several limitations to our study include our
confinement to IBD patients whose treatment
gained NFZ reimbursement. Our analysis exclud
ed patients treated as part of clinical trials. We
have no insight on theproportion of IBD patients
given biologic drugs in non ‑NFZ contexts. Afur
ther problem related to alack of precise compara
bility reflects changing regulations of thethera‑
peutic programs, above all regarding limited du‑
rations and thevariety of drugs available. Equal
ly, some IBD patients were enrolled in both of
thetherapeutic programs analyzed (B.32 and
B.55), due to changes in diagnosis (most often
from UC to CD). at confers aslight bias upon
thepercentage of patients treated for thepartic
ular diseases. Moreover, theaforementioned un
equal geographic access to thetherapeutic pro
grams might also have generated aselection bias.
To conclude, our analysis of theuse of biolog‑
ic drugs among Polish IBD patients over thelast
decade confirmed aslow increase, sex ‑based dif‑
ferences, age ‑related differences, and anunequal
geographic distribution of gastroenterological ser
vices providing thebiologic therapy in individu‑
al Polish voivodeships. ese results may in part
reflect alimited access to innovative therapies
due to tight reimbursement criteria. We believe
these data are of importance atthe national lev‑
el, especially for those involved in theplanning of
thehealth policy, but also for medical profession
als all over theworld who deal with IBD patients.
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... IBD encompasses mainly two chronic inflammatory conditions: Crohn's disease (CD) and ulcerative colitis (UC). They differ in multiple clinical aspects, nevertheless targeting inflammation with biological drugs, like anti-TNF agents, which have the potential to hinder IL-33 synthesis yields good results [2][3][4][5]. ...
... Anti-TNF therapy is effective and has a good safety profile [21][22][23]. It does not appear to cause sleep disruptions, with some studies showing it even might improve sleep quality [3,24,25]. ...
Full-text available
Introduction: Inflammatory bowel diseases (IBD) might be accompanied by emotional disturbances. Circadian rhythm genes, brain and muscle ARNT-Like 1 (BMAL1), circadian locomotor output cycles kaput (CLOCK), neuronal PAS domain protein 2 (NPAS2), nuclear receptor subfamily 1 group D member 1 (NR1D1) bear relation to inflammation and psychiatric symptoms, thus might modulate their interactions. Objectives: The study aimed to compare the expressions of BMAL1, CLOCK, NPAS2, NR1D1 mRNA between IBD patients and healthy controls (HC). The association between genes' expressions and disease severity, anti-TNF therapy, sleep quality, insomnia, and depression was evaluated. Patients and methods: Eighty-one IBD patients and 44 HC were recruited and divided according to disease activity and IBD type (ulcerative colitis (UC), Crohn's disease (CD)). Questionnaires assessing sleep quality, daytime sleepiness, insomnia, and depression were filled out. Venous blood was collected; IBD subjects who underwent anti-TNF therapy had their blood drawn before and after 14 weeks of treatment. Results: The IBD group had decreased expression of all studied genes, but BMAL1 compared to HC. UC individuals with exacerbation had decreased expression of CLOCK and NPAS2 compared to remission group; UC severity was negatively correlated with CLOCK, NPAS2, NR1D1 mRNA. IBD participants with depression symptoms had decreased expression of CLOCK and NR1D1 compared to those without mood disturbances. Poor sleep quality was associated with decreased expression of NR1D1. Biological treatment decreased BMAL1 expression. Conclusions: Disruption of clock genes expressions might constitute a molecular background of sleep disorders and depression in IBD as well as contribute to UC exacerbation.
... Herein we aimed to verify this discovery through a study involving a larger group of 196 patients with CD. In our study group, the number of male patients was higher than female (77 vs. 119, Table 1), which reflects the observation made by Kucha et al. in Polish nationwide data for 2012-2020 that women receive biological treatment for both the CD and UC significantly less frequently than men [16]. We assessed 5 loci identified in 2020 (rs7539036, rs2041747, rs5746053, rs1143634, rs7896789) in the FCGR3A, IL1R, TNFRSF1B, IL1 and FAS genes, respectively. ...
Full-text available
Introduction: Crohn's disease (CD) is a chronic inflammatory disease characterized by an uncontrolled immune response by the intestinal mucosa cells to antigens derived from the gut lumen. Specifically, the introduction of anti-TNF drugs changed the approach to inflammatory bowel disease (IBD) treatment and set new therapeutic goals as controlling clinical symptoms while simultaneously achieving complete endoscopic and mucosal remission. Mechanism of action of - and therefore mechanisms of resistance to anti-TNF therapy are unknown. Objectives: Our research is an attempt to answer whether the potential mechanism of non-responders may be conditioned by polymorphisms in genes involved in independent inflammatory or apoptotic pathways. Patients and methods: The study included 196 diagnosed and clinically characterized CD Polish patients following anti-TNF therapy. Variants rs7539036, rs2041747, rs5746053, rs5746054, rs1061624, rs1143634, rs7896789, and rs55790676 of the FCGR3A, IL1R, TNFRSF1B, IL1B, FAS, and ADAM17 genes, respectively, were genotyped using Sanger sequencing and were analysed with the response to biological treatment. Results: We observed that 33 patients (16.8%) did not respond to the induction therapy, which was associated with the ILR1 rs2041747 G allele (OR 3.72, P = 0.009). Moreover, the FAS rs7896789 CC homozygote related with increased susceptibility to anti-TNF therapy nonresponse (OR 15.22, P = 0.003) and TT might act as the protective genotype. Conclusions: In CD patients' response to anti-TNF therapy, complex pathways with multigene conditioning participate. Genes involved in apoptosis, FAS, and ILR1, seem to play here an essential role, and are an interesting object for further, population and functional, research.
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Introduction: The epidemiology of inflammatory bowel disease (IBD) in Poland has been recognized to only a limited extent Objectives: W aimed to estimate the prevalence and incidence of the aforementioned disease by analysing data from the National Health Fund, Poland's sole public-health insurer. Patients and methods: Administrative health claims collected over the 2009-2020 period were used to identify patients with Crohn's disease (CD) or ulcerative colitis (UC). A definition of a case comprised ≥2 records assigned K50 or K51 codes, plus ≥2 prescriptions for IBD drugs reimbursed, or else intestinal surgery preceding the record. The crude and European age-standardized rates (EASR) and 95% confidence intervals (CI) were calculated for prevalence and incidence. Time trends were also analyzed. Results: As of 2020 there were 23,574 patients with CD and 73,235 with UC. The CD and UC prevalence was respectively 61.6 [EASR 60.3] and 191.4 [EASR 187.85] per 100,000. The prevalence of CD was higher in men [64.1; EASR 61.3] than in women [59.3; EASR 58.4]. Similarly, the prevalence of UC was higher in men [201.4; EASR 202.7] than in women [182.0; EASR 175.5]. The incidence of CD was 4.7 per 100 000 [EASR 4.6], that of UC 12.5 [EASR 12.3]. Through the period 2012-2018, the prevalence of both conditions rose, even as downward trends were noted for disease incidence. Conclusions: The prevalence and incidence of IBD in Poland are presented, with time trends showing a substantial increase in the disease burden over the years 2009-2020.
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Purpose The therapeutic effect of top-down therapy for inflammatory bowel disease (IBD) has not been fully evaluated in real-world clinical settings. We compared the effectiveness of top-down and step-up therapies for IBD. Methods We retrospectively evaluated patients who were admitted with IBD (Crohn’s disease [CD] or ulcerative colitis [UC]) between 2012 and 2019 using the nationwide Japan Diagnosis Procedure Combination database. Patients who received immunomodulators or biologic agents at the start of observation were assigned to the top-down group and those who did not were enrolled in the step-up group. Relapse was the primary outcome, a composite outcome defined as surgery, new steroid or immunomodulator use, hospitalization, a new biologic agent, or switching biologic agents. Results We analyzed 6715 patients (CD, N = 3643; UC, N = 3072). Relapse occurred in 1982 CD cases (54.4%). The cumulative CD relapse incidence was 32.9% at 1 year and 61.3% at 5 years in the top-down group and 30.7% at 1 year and 58.6% at 5 years in the step-up group. Relapse occurred in 2032 UC cases (47.8%). The cumulative relapse incidence was 33.5% at 1 year and 50.0% at 5 years in the top-down group and 35.2% at 1 year and 51.6% at 5 years in the step-up group. No clinical factors associated with relapse were identified in patients with CD or UC. Conclusion Compared with step-up therapy, top-down therapy was not associated with a decreased relapse risk in a real-world population of patients with CD or UC.
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Objectives: The use of biologic therapy in inflammatory bowel disease (IBD) is likely to increase with lower costs and more biologics and biosimilars becoming available. Our aim was to estimate the trends in use of first-line biologics during the first year after diagnosis in a Norwegian IBD population from 2010 to 2016. Methods: Data were collected from the Norwegian National Patient Registry and Norwegian Prescription Database. Patients defined as incident IBD cases between 2010 and 2016 were included and followed for 12 months. Patients were stratified by year of diagnosis to examine change over time. Chi-square test was used for calculations on proportions. Time from diagnosis to first biologic was calculated by Kaplan-Meier failure estimates. Results: 14,645 patients were included, 5283 (36%) with Crohn's disease (CD) and 9362 (64%) with ulcerative colitis (UC). In the 2010 and 2016 cohort, the proportion initiating biologics increased from 17% to 33% (p < .001) for CD and 7% to 13% (p < .001) for UC. The most frequently used first-line biologics were infliximab (CD: 64% and UC: 82%) and adalimumab (CD: 36% and UC: 15%). The highest registered use of adalimumab was in the 2012 cohort (CD: 56% and UC: 39%). In the 2014-2016 cohorts, infliximab was the most used first-line biologic for both CD and UC. Conclusions: The proportion of IBD patients initiating biologics within 12 months after diagnosis increased between 2010 and 2016. The use of infliximab as first-line biologic increased after the approval of biosimilar infliximab in 2013.
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Purpose: We aimed to investigate clinical outcomes between top-down (TD) and conventional step-up (SU) therapies in pediatric patients with moderate to severe ulcerative colitis (UC). Materials and methods: All patients underwent clinical and endoscopic evaluation at diagnosis and 4 months and 1 year after treatment. Patients who started treatment with corticosteroid were grouped in the SU group, while those that initiated early infliximab (IFX) were grouped in the TD group. Among the SU group, patients who eventually changed to IFX treatment due to steroid resistance or dependency were included in the SU(R) group. Results: In total, 44 children with moderate to severe UC were included for analysis. Twenty-one patients were included in the SU group, 23 were included in the TD group, and 10 were enrolled in the SU(R) group. Relapse rates were 47.6% (10/21) in the SU group and 17.4% (4/23) in the TD group (p=0.033). Among relapsed patients, the durations from remission to relapse were 17.3 months (0.9-46.9) in the SU group and 24.3 months (1.8-44.9) in the TD group. There was no statistically significant difference in the sustained durations of remission after IFX administration between the SU(R) and TD groups [3.9 (1.4-6.3) and 2.3 (0.3-5.2) years, respectively (p>0.05)]. Conclusion: According to our study, early use of IFX without corticosteroid treatment for children with moderate to severe UC helps to lower relapse rates. We also found that IFX was a very effective treatment for pediatric UC, with a sustained duration of remission similar between TD and SU(R) groups.
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Background It is not known to what extent biologic treatment for IBD is captured in the Swedish Prescribed Drug Register (PDR) and the National Patient Register (NPR). Methods A cross-sectional study from July 2005 until 2017, comparing data on biologic treatment in the PDR and the NPR with medical records. We assessed the proportion of started treatment episodes in the medical records that were found in the PDR/NPR ever, within +/− one year and within +/− three months; for any biologic drug, per specific drug (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab), by calendar period (2005–2008, 2009–2012, and 2013–2017) and by study center. For adalimumab, we assessed the validity of end of treatment episodes. Results Medical records of 1361 patients and 2323 treatment episodes with any biologic were reviewed and 80.1% (95% CI: 78.4–81.7) were ever captured in the PDR/NPR in. A time window of +/− one year or +/− three months reduced the sensitivity to 63.3% (95% CI: 61.3–65.3) and 52.6% (95% CI: 50.5–54.6), respectively. The sensitivity was high (>85%) for the prescribed injection drugs adalimumab, golimumab, and ustekinumab for all time windows and for adalimumab end of treatment, while considerably lower for the infusion drugs infliximab and vedolizumab. Conclusions The PDR and the NPR are reliable data sources on treatment with injection biologics in patients with IBD in Sweden. Infliximab and vedolizumab are poorly captured, why PDR/NPR data should only be used after careful consideration of their limitations or complemented by other data sources, e.g., the disease-specific quality register SWIBREG.
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Background: In rheumatoid arthritis and psoriasis female sex has been shown to be associated with discontinuation of anti-tumour necrosis factor-α (TNF-α) therapy. Aim: To retrospectively assess the association between sex and TNF-α drug persistence in patients with inflammatory bowel disease (IBD). Methods: All IBD patients on anti-TNF-α therapy with a minimum follow-up of 12 months in a single tertiary centre were identified. Patient and treatment characteristics and reasons for anti-TNF-α discontinuation were recorded. Overall and cause-specific drug persistence was analysed with Kaplan-Meier followed by Cox proportional hazards regression models. Results: We included 529 patients (49.9% male) with 631 treatment episodes (2280 anti-TNF-α treatment years) and 289 discontinuations of therapy. Female sex (adjusted hazard ratio [aHR] 1.42, 95% confidence interval [CI] 1.16-1.74), greater age at start of therapy per decade (aHR 1.15, 95% CI 1.04-1.27] and dose escalation (aHR 3.74, 95% CI 2.78-5.02) were associated with TNF-α inhibitor discontinuation. Total cohort cause-specific analysis identified female sex to be associated with side effects (aHR 4.05, 95% CI 2.36-6.98) but not to other discontinuation reasons. Adalimumab (aHR 1.70, 95% CI 1.11-2.60) and golimumab (aHR 4.97, 95% CI 2.30-10.74) use and dose-escalation (aHR 7.71, 95% CI 5.28-11.26) were associated with secondary loss of response. Conclusion: Drug persistence of anti-TNF-α therapy is lower in females as compared to males, mainly because of higher rates of side effects in females. Understanding the sex specific differences in effectiveness and safety of anti-TNF-α compounds can aid physicians in clinical decision-making.
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Background: The frequency of upper gastrointestinal (GI) tract involvement in Crohn`s disease (CD) has been reported with a large variation. Risk factors and disease course of patients with upper GI tract involvement remain largely elusive. Methods: Data on CD patients in the Swiss Inflammatory Bowel Disease Cohort were analyzed. Patients with upper GI tract involvement were compared to controls. Logistic regression models for prediction of upper GI tract involvement and Cox proportional hazard models for occurrence of complications were computed. Results: We included 1638 CD patients, of whom 107 (6.5%) presented with upper GI tract involvement at the time of diagnosis and 214 (13.1%) at any time. Prevalence of such involvement at diagnosis increased over time (5.1% for 1955-1995 vs. 11.3% for 2009-2016). In a multivariate logistic regression model, male sex and diagnosis between 2009-2016 (vs. before 1995) were independent predictors for presence of upper GI tract involvement at CD diagnosis (OR 1.600, p=0.021 and OR 2.686, p<0.001), while adult age was a negative predictor (OR 0.388, p=0.001). Patients with upper GI tract involvement showed a disease course similar to control patients (HR for any complications 0.887 [95% CI 0.409-1.920]), and a trend towards occurrence of fewer intestinal fistulas (log-rank test p=0.054). Conclusions: Prevalence of upper GI tract involvement has been increasing over the past decades. Male sex and young age at diagnosis were identified as the main predictive factors for such involvement at CD diagnosis. Involvement of upper GI tract did not result in a worse outcome.
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The management of Crohn’s disease involves immunosuppressive protocols in a step-up approach that progresses through a therapeutic pyramid with several tiers of medication. Medications at the top are considered more potent but present greater risk. A new top-down approach to therapy inverts this procedure, using top-tier drugs for initial treatment. A critical appraisal of the current literature relating to top-down therapy was performed to evaluate its merit. A literature search was conducted on PubMed, Ovid, and PubMed Central to identify studies of the efficacy of top-down therapy. Papers were appraised critically using the Scottish Intercollegiate Guidelines Network score to evaluate current evidence for the use of top-down therapy. Nineteen studies were identified, including six randomized controlled trials, thirteen cohort studies, and two cost-benefit studies. Early combined therapy involving both biologics and immunomodulators was found to be effective at improving patient outcomes; however, early biologics alone were not shown to have a clear benefit over step-up therapy. Likewise, the early use of immunomodulators alone showed inconsistent results with respect to efficacy in terms of both remission and surgical outcomes. Evidence for application in pediatric populations was also inconclusive. The cost-benefit analyses found that top-down therapy merits investigation, as it proved to be economical given current data. Top-down therapy has the potential of being a viable alternative to step-up therapy, but further studies are needed to determine the most appropriate patients to receive this treatment.
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Background Real-life data on inflammatory bowel disease (IBD) prevalence and costs are scarce. The aims of this study were to provide an overview of the prevalence, mortality, health care utilization and costs of IBD patients in Switzerland in the years 2010, 2012, and 2014. Methods Based on claims data of the Helsana-Group, prevalence of IBD was assessed for 2010, 2012 and 2014. Mortality rates, costs (inpatient, outpatient, medication costs) and utilization (visits, hospitalizations) were compared between patients with and without IBD, and between IBD patients treated with and without biologics. Results were extrapolated to the Swiss general population using national census data. Multivariate linear regression was used to identify socio-demographic and regional factors influencing total costs. Results The overall extrapolated prevalence rates of IBD were 0.32% in 2010, 0.38% in 2012, and 0.41% in 2014. Mortality rate didn’t differ between the IBD and non-IBD population. Costs increased annually by 6% in IBD versus 2.4% in non-IBD subjects, which was solely due to increased outpatient costs. Almost one-fourth of IBD patients were hospitalized at least once a year. Costs were higher in IBD patients treated with biologics (OR = 3.98, CI: 3.72-4.27, p < 0.001) when compared to IBD patients without biologic therapies. Over 70% of the total costs in IBD patients treated with biologics were due to drug costs, compared with 28% in patients without use of biologic therapies, whereas inpatient costs didn’t differ. Conclusions The prevalence of IBD seems to be increasing in Switzerland. Outpatient costs increased substantially, while no decrease in inpatient costs was found. Treatment of IBD is more and more based on biologic therapies. Electronic supplementary material The online version of this article (10.1186/s12876-017-0681-y) contains supplementary material, which is available to authorized users.