BioMed Cen al
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BMC Gas oen e ology
Open Access
Resea ch a icle
E icacy and sa e y o in liximab induc ion he apy in C ohn's
Disease in Cen al Eu ope - a Hunga ian na ionwide obse a ional
s udy
Pál Mihelle *1, Pé e L Laka os2, Gábo Ho á h3, Tamás Molná 4,
Tamás Szamosi5, Zsó ia Czeglédi5, Ágnes Salamon6, Józse Czimme 7,
Gyö gy Rumi7, Ká oly Pala ka8, Má ia Papp8, Zsol Jakab9, And ea Szabó10,
And ás Gelley11, László Laka os12, Zsol Ba a13, Csaba Balázs11,
Is án Rácz10, Ma gi Zehe 13, Zol án Döb ön e9, Is án Al o jay8,
Béla Hunyady7, László Simon6, János Papp2, János Banai5, Fe enc Nagy4,
János Lono ics4, László Újszászy3, Gyö gyi Műzes1, László He szényi1 and
Zsol Tulassay1
Add ess: 12nd Depa men o Medicine, Semmelweis Uni e si y, Budapes , Hunga y, 21s Depa men o Medicine, Semmelweis Uni e si y,
Budapes , Hunga y, 31s Depa men o Medicine, Semmelweis Hospi al, Miskolc, Hunga y, 41s Depa men o Medicine, Facul y o Medicine,
Uni e si y o Szeged, Szeged, Hunga y, 5Depa men o In e nal Medicine, Na ional Medical Cen e , Budapes , Hunga y, 62nd Depa men o
In e nal Medicine, Balassa János Hospi al, Szekszá d, Hunga y, 71s Depa men o Medicine, Uni e si y o Pécs, Facul y o Medicine, Pécs,
Hunga y, 82nd Depa men o Medicine, Uni e si y o Deb ecen, Facul y o Medicine, Deb ecen, Hunga y, 92nd Depa men o In e nal Medicine,
Ma kuso szky Hospi al, Szomba hely, Hunga y, 101s Depa men o Medicine, Pe z Aladá Hospi al, Győ , Hunga y, 11Depa men o In e nal
Medicine, Polyclinic o he Hospi alle B o he s o S John o God, Budapes , Hunga y, 121s Depa men o Medicine Csolnoky Fe enc Hospi al,
Veszp ém, Hunga y and 133 d Depa men o Medicine, Uni e si y o Deb ecen, Facul y o Medicine, Deb ecen, Hunga y
Email: Pál Mihelle * - [email protected]; Pé e L Laka os - kislakpe @bel1.so e.hu; Gábo Ho á h - [email protected];
Tamás Molná - mo @in1s .szo e.u-szeged.hu; Tamás Szamosi - sza[email p o ec ed]; Zsó ia Czeglédi - [email p o ec ed];
Ágnes Salamon - [email p o ec ed]; Józse Czimme - jo[email p o ec ed].hu; Gyö gy Rumi - [email p o ec ed];
Ká oly Pala ka - pala k[email p o ec ed]; Má ia Papp - d papp[email p o ec ed]; Zsol Jakab - [email p o ec ed];
And ea Szabó - szaboand ea@pe z.gyo .hu; And ás Gelley - gie gl@ eemail.hu; László Laka os - [email p o ec ed];
Zsol Ba a - ba [email protected] e.hu; Csaba Balázs - d balazs@i galmas.hu; Is án Rácz - [email p o ec ed];
Ma gi Zehe - [email p o ec ed]; Zol án Döb ön e - dob on e.zol an@ma kuso szky.hu; Is án Al o jay - al o jay@jagua .unideb.hu;
Béla Hunyady - [email p o ec ed]; László Simon - simonl@ho mail.com; János Papp - [email protected] e.hu;
János Banai - b[email p o ec ed]; Fe enc Nagy - [email p o ec ed]ed.hu; János Lono ics - lon@in1s .szo e.u-szeged.hu;
László Újszászy - u[email p o ec ed]; Gyö gyi Műzes - [email protected] e.hu; László He szényi - he [email protected] e.hu;
Zsol Tulassay - [email p o ec ed]o e.hu
* Co esponding au ho
Abs ac
Backg ound: In liximab (IFX) has p o en o be an e ec i e addi ion o he he apeu ic a senal o
e ac o y, is ulizing, and s e oid dependen C ohn's disease (CD), wi h e icacy in he induc ion
and main enance o clinical emission o CD. Ou objec i e in his s udy is o epo he na ionwide,
mul icen e expe ience wi h IFX induc ion he apy o CD in Hunga y.
Published: 10 Sep embe 2009
BMC Gas oen e ology 2009, 9:66 doi:10.1186/1471-230X-9-66
Recei ed: 12 Decembe 2008
Accep ed: 10 Sep embe 2009
This a icle is a ailable om: h p://www.biomedcen al.com/1471-230X/9/66
© 2009 Mihelle e al; licensee BioMed Cen al L d.
This is an Open Access a icle dis ibu ed unde he e ms o he C ea i e Commons A ibu ion License (h p://c ea i ecommons.o g/licenses/by/2.0),
which pe mi s un es ic ed use, dis ibu ion, and ep oduc ion in any medium, p o ided he o iginal wo k is p ope ly ci ed.
BMC Gas oen e ology 2009, 9:66 h p://www.biomedcen al.com/1471-230X/9/66
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Me hods: Du ing a 6-yea -pe iod, beginning in 2000, a o al o 363 CD pa ien s we e ea ed wi h
IFX as induc ion he apy (5 mg/kg IFX in usions gi en a week 0, 2 and 6) a ele en cen e s in
Hunga y in his obse a ional s udy. Da a analysis included pa ien demog aphics, impo an disease
pa ame e s and he ou come o IFX induc ion he apy.
Resul s: Th ee hund ed and six y h ee pa ien s (183 women and 180 men) we e ea ed wi h IFX
since 2000. Mean age was 33.5 ± 11.2 yea s and he mean du a ion o disease was 6.7 ± 6.1 yea s.
The popula ion included 114 pa ien s (31.4%) wi h he apy- e ac o y CD, 195 pa ien s (53.7%)
wi h is ulas, 16 pa ien s (4.4%) wi h bo h he apy- e ac o y CD and is ulas, and 26 pa ien s (7.2%)
wi h s e oid dependen CD. O e all esponse a e was 86.2% (313/363). A highe esponse a e
was obse ed in pa ien s wi h sho e disease du a ion (p = 0.05, OR:0.54, 95%CI:0.29-0.99) and
concomi an immunosupp essan he apy (p = 0.05, OR: 2.03, 95%CI:0.165-0.596). Concomi an
s e oid ea men did no enhance he e icacy o IFX induc ion he apy. Ad e se e en s included
34 alle gic eac ions (9.4%), 17 delayed ype hype sensi i i y (4.7%), 16 in ec ions (4.4%), and 3
malignancies (0.8%).
Conclusion: IFX was sa e and e ec i e ea men in his coho o Hunga ian CD pa ien s. Based
on ou expe ience co-adminis a ion o immunosupp essan he apy is sugges ed in pa ien s
ecei ing IFX induc ion he apy. Howe e , concomi an s e oid ea men did no enhanced he
e icacy o IFX induc ion he apy.
Backg ound
In liximab (IFX) is a chime ic monoclonal an ibody ha
binds soluble and memb ane bound umo nec osis ac-
o -alpha (TNF-α). P e ious s udies ha e demons a ed i s
e icacy in e ac o y, is ulizing, and s e oid dependen
C ohn's disease (CD) [1,2]. Fu he mo e, o he s udies
ha e shown i s e icacy as main enance he apy o CD
[3], mo eo e as induc ion and main enance he apy o
ulce a i e coli is [4].
In Hunga y, IFX has been used in clinical s udies since
2000, and has se ed as an impo an componen o he
he apeu ic a senal o he ea men o CD since 2003.
Financial conside a ions limi he use o IFX ea men o
CD o ele en Hunga ian Gas oen e ological Cen e s
which a e licensed o i s adminis a ion. Ini ially, IFX was
a ailable only o induc ion he apy o pa ien s su e ing
om is ulizing, he apy esis an , o s e oid dependen
CD. Howe e , as clinical e idence demons a es he e i-
cacy o IFX o main enance he apy [3], cu en ly IFX is
a ailable o main enance he apy as well. The objec i e
o his obse a ional s udy is o epo he na ionwide,
mul icen e expe ience wi h IFX induc ion he apy o CD
in Hunga y.
Me hods
This obse a ional s udy was ini ia ed in 2004, he e o e a
po ion o he pa ien da a (2000 h ough 2004) a e e o-
spec i e. Pa ien da a h ough six yea s om ele en Hun-
ga ian Gas oen e ological Cen e s a e included in his
analysis. Mic oso ® Excel da abases we e used o compile
and p ocess pa ien da a including demog aphic cha ac-
e is ics, localiza ion and beha iou o he disease, con-
comi an medica ion, indica ion o biological he apy
and ou come o IFX induc ion he apy we e egis e ed e -
ospec i ely. The s udy p o ocol was e iewed and
app o ed by he Semmelweis Uni e si y Regional and
Ins i u ional Commi ee o Science and Resea ch E hics.
Pa ien s wi h C ohn's Disease eligible o his obse a-
ional s udy had 1) single o mul iple discha ging abdom-
inal and/o pe ianal is ulas o a leas 3-6 mon hs
du a ion despi e con en ional immunosupp essan and
an ibio ic he apy; 2) he apy e ac o y/s e oid depend-
en luminal disease. Mino i y o pa ien s had ac i e lumi-
nal and is ulizing disease as well. Pa ien s who a e ei he
unable o educe co icos e oids below he equi alen o
p ednisolone 10 mg/day wi hin h ee mon hs o s a ing
co icos e oids wi hou ecu en ac i e disease, o who
ha e a elapse wi hin h ee mon hs o s opping co icos-
e oids we e de ined as co icos e oid dependen pa ien .
Co icos e oid e ac o y disease was de ined as ac i e dis-
ease despi e p ednisolone up o 0.75-1 mg/kg/day o e a
pe iod o ou weeks de ined as s e oid e ac o y. Pa ien s
who no ole a e AZA in a dose a leas 1.5 mg/kg body
weigh we e conside ed as AZA in ole an . Failu e o
immunosup essan s (AZA o else) he apy o AZA in ole -
ance was an indica ion o IFX he apy also.
As induc ion he apy i e mg/kg body weigh o in lixi-
mab was adminis e ed in a 2 hou in usion a weeks 0, 2
and 6. In is ulizing disease esponse was de ined as a
dec ease o 50% o mo e in he numbe o discha ging is-
ulas compa ed o baseline and emission was de ined as
absence o any discha ging is ulas measu ed a week 12.
In pa ien s wi h he apy- e ac o y o s e oid dependen
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luminal disease he esponse was de ined as a ≥70 poin s
dec ease in CDAI and a CDAI alue below 150 was con-
side ed as clinical emission a week 12. The C ohn's Dis-
ease Ac i i y Index (CDAI) was calcula ed only in cases
wi h s e oid dependen o he apy- e ac o y luminal dis-
ease.
In liximab 5 mg/kg body weigh was gi en as main e-
nance he apy a e week 6. Main enance was gi en e e y
8 weeks. The ini ia ion o he main enance he apy was
based on he assessmen o esponse ollowing he induc-
ion egimen. Howe e , inancial es ic ions p e en ed a
signi ican p opo ion o pa ien s om ecei ing main e-
nance he apy. Con en ional induc ion he apy (1 mg/kg
body weigh s e oid he apy) was s a ed in case o ea ly
disease elapse in pa ien s wi h luminal CD. In case o la e
elapse (de ined as elapse a e a leas 6 mon hs o emis-
sion) IFX e-induc ion egimen was adminis e ed.
S a is cal me hods
Va iables we e es ed o no mali y using Shapi o Wilk's
W es . T- es wi h sepa a e a iance es ima es, ANOVA
wi h pos hoc Sche e es , χ2- es , and χ2- es wi h Ya es
co ec ion we e used o e alua e di e ences wi hin sub-
g oups o IBD pa ien s. The esul s a e p esen ed as means
± SD. Associa ion be ween esponse, emission and clini-
cal a iables (wi h a iables wi h a p < 0.2 in uni a ia e
analysis) was also es ed by using logis ic eg ession anal-
ysis. A p alue o < 0.05 was conside ed as signi ican . Fo
he s a is ical analysis, SPSS15.0 (SPSS Inc, Chicago, IL)
was used.
Resul s
Du ing a 6-yea -pe iod 363 CD pa ien s we e ea ed wi h
IFX. The coho comp ised 183 emales and 180 males;
he mean age was 33.5 ± 11.2 yea s and he mean du a ion
o disease was 6.7 ± 6.1 yea s a he ime o ini ia ion o
induc ion he apy.
One hund ed and nine y i e (53.7%) is ulizing, 114
(31.4%) he apy- e ac o y, and 26 (7.2%) s e oid
dependen CD pa ien s we e ea ed. All pa ien s we e
naï e o TNFα-inhibi o he apy. Fi e (0.1%) pa ien s
wi h me as a ic CD and 7 (0.2%) pa ien s wi h ex a-in es-
inal mani es a ions we e also ea ed, bu hese pa ien s
we e no a ailable o assessmen o esponse. The de ails
ega ding he speci ic indica ions o IFX he apy a e sum-
ma ized in Table 1.
Du ing he obse a ion pe iod 1,532 IFX in usions we e
adminis e ed. Comple e induc ion egimen was pe -
o med in 299 pa ien s (82.3%). O e all esponse a e
was 86.2% hus 313 pa ien s ou o he 363 esponded o
he induc ion he apy. De ails ega ding he esponse a es
a e shown in Table 1. The o e all emission a e was
46.0% (167 ou o 363 pa ien s) a e IFX induc ion he -
apy. De ailed da a on emission a es a e shown in Table
2.
Among 304 (83.7%) pa ien s ea ed simul aneously wi h
immunosupp essan s, 268 esponded (88.2%), and 36
ailed o espond (11.8%). Fi y nine (16.2%) pa ien s did
no ecei e any concomi an immunosupp essan s and
he esponse a e was lowe in hese pa ien s espec o
hose on concomi an immunosupp essi e he apy (73%
s 88.2%, p < 0.05). Among pa ien s wi h concomi an
immunosupp essan s, aza hiop ine (AZA) was used mos
equen ly (78.9%). O he immunosupp essan he apies
included me ho exa e (5.9%), and only one pa ien
(0.3%) was ea ed wi h cyclospo ine and ano he wi h
mycophenola e mo e il (0.3%). Response a e o IFX
induc ion he apy was highe in pa ien s ecei ing con-
comi an AZA o me ho exa e (88.3% s. 76.6%, p =
0.014).
Du ing induc ion he apy co-adminis a ion o p e-in u-
sion co icos e oid he apy was applied in 165 pa ien s.
Response a es we e simila o pa ien s wi h o wi hou
concomi an s e oid ea men (88.5% s. 85.8%, espec-
i ely, p = NS).
Pa ien s who achie ed emission o esponse a e induc-
ion he apy we e signi ican ly younge han pa ien s clas-
si ied as non- esponde s (26.8 ± 10.4 yea s s. 33.2 ± 11.5
yea s o age, p < 0.01), u he mo e he du a ion o CD
was sho e (5.9 ± 5.5 yea s s. 7.2 ± 4.3 yea s, p < 0.001).
Abdominal su ge y p io o IFX he apy was pe o med in
25.1% o CD pa ien s. This subse o pa ien s was olde in
age (35 ± 10.9 yea s o age, p = 0.01), and he mean du a-
ion o disease was longe (8.5 ± 6.3 yea s, p < 0.0001)
compa ed o he en i e g oup o pa ien s. Among pa ien s
wi h p e ious su gical in e en ion 75% esponded o IFX
induc ion he apy.
Ou o 167 pa ien s in emission 136 (81.4%) ecei ed
simul aneous immunosupp essi e egimen. The majo i y
o pa ien s in emission ecei ing concomi an immuno-
supp essan s we e ea ed wi h AZA (132 pa ien s,
97.0%), 4 pa ien s (2.9%) ecei ed me ho exa e, and
mesalazine o sulphasalazine was used in 128 (93.4%)
and 8 (5.9%) o hem espec i ely.
A logis ic eg ession analysis was pe o med o es he
associa ion be ween clinical a iables, concomi an med-
ical he apy and emission and esponse o IFX induc ion
ea men (Table 3.). Du a ion (p = 0.05, OR: 0.54,
95%CI: 0.29-0.99) and concomi an s e oid he apy (p =
0.027, OR: 0.54, 95%CI: 0.31-0.93) we e associa ed wi h
emission a week 12 in he same logis ic eg ession anal-
ysis.
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Ad e se e en s du ing induc ion ea men we e obse ed
in 78 pa ien s (21.5%, 3.86/100 pa ien -yea s). Alle gic
eac ions we e de ec ed in 34 pa ien s (43.6% o all
ad e se e en s, 1.56/100 pa ien -yea s) including 4 e en s
p og essing o anaphylac ic shock - IFX he apy was
immedia ely discon inued in hese cases. Pa ien s su e -
ing om mild o mode a e alle gic eac ions we e able o
inish he IFX he apy by p e-adminis e ing pa en e al co -
icos e oids. Despi e p e ious se e e alle gic eac ions, in
2 pa ien s success ul desensi iza ion was pe o med wi h
s epwise dilu ed IFX and hey we e subsequen ly e-chal-
lenged wi h con inua ion o hei IFX induc ion he apy.
Delayed ype hype sensi i i y eac ions (DTHR), cha ac-
e ized by muscle pain, e e , join pain and skin ashes
we e obse ed in 17 pa ien s (0.78/100 pa ien -yea s). In
i e o hese cases he DTHR occu ed a e he 2nd in u-
sion o IFX induc ion egimen, and only one pa ien was
able con inue IFX he apy a e esolu ion o he DTHR.
In ec ions we e obse ed in 16 pa ien s (4.4%, 0.73/100
pa ien -yea s) including se ious in ec ions in 5 pa ien s
(0.01%, 0.23/100 pa ien -yea s) such as wo cases o
ube culosis, wo in a-abdominal abscesses, and one
meningeal Lis e iosis. The majo i y o in ec ions (11/16,
68.8%) occu ed in pa ien s ea ed wi h concomi an
immunosupp essan s. No a al in ec ious complica ions
we e obse ed.
In ou cases symp oms o gu s enosis de eloped a e IFX
he apy (0.55%, 0.011/100 pa ien -yea s), wo cases
equi ed su ge y.
Th ee cases o malignan solid umo s we e obse ed
(0.82%, 0.137/100 pa ien -yea s). The i s case was diag-
nosed on he 2nd week o he apy, and was conside ed
un ela ed o IFX ea men . In his case, an abdominal
abscess was he ini ial diagnosis because o high e e and
di use, sha p abdominal pain. Howe e , he diagnosis o
colon malignancy was con i med based on his ological
e alua ion o a issue sample. In he second case he
malignancy was diagnosed in a pa ien 5 mon h a e he
s a o induc ion he apy. This pa ien had se e e he apy-
esis an and is ulizing CD wi h a 15-yea disease du a-
Table 1: Indica ions and esponse a es o in liximab induc ion he apy
Indica ion o IFX he apy Numbe and a e o disease ype Response a e a e induc ion
The apy- e ac o y CD 114 (31.4%) 83.3%
By localiza ion
Ileum 10 (8.77%)
Colon 29 (25.4%) 79.3%
Ileo-colonic 46 (40.4%) 87.0%
Ileo-colonic and small bowel 28 (24.6%) 78.6%
Oesophagus 1 (0.9%) 1/1
The apy- e ac o y and is ulizing 16 (4.4%) 93.8%
Fis ulizing 195 (53.7%) 85.6%
By localiza ion
Pe ianal 148 (75.9%) 91.2%
En e ocu aneous 24 (12.3%) 87.5%
En e o aginal 11 (5.6%) 9/11
O he 12 (6.2%) 7/12
Mixed 7 (3.6%) 5/7
S e oid dependen 26 (7.2%) 92.3%
By localiza ion
Ileum 3 (11.5%) 3/3
Colon 4 (15.4%) 4/4
Ileo-colic 19 (73.1%) 17/19
Me as a ic 5 (0.1%) Na.
O he 7 (0.2%) Na.
Na = no applicable
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Table 2: Remission a e a e in liximab induc ion he apy
Indica ion o IFX he apy Numbe and a e o emission
O e all 167 (46%)
The apy- e ac o y CD
by localiza ion
45 (39.47%)
Ileum 3/10 (30%)
Colon 7/29 (24.13%)
Ileo-colonic 29/46 (63.04%)
Ileo-colonic and o he small bowel 5/28 (17.85%)
Oesophagus 1/1
The apy- e ac o y and is ulizing 6 (37.5%)
Fis ulizing 95 (48.71%)
Pe ianal 72/148 (48.64%)
En e ocu aneous 7/24 (29.16%)
En e o aginal 3/11
O he 4/12
Mixed 6/7
S e oid dependen 15 (57.69%)
Ileum 3/3
Colon 3/4
Ileo-colic 9/19 (47.36%)
Me as a ic 5 Na.
O he 1 Na.
Na = no applicable
Table 3: Logis ic eg ession: P edic i e ac o s o esponse o IFX induc ion he apy a week 12 in C ohn's disease
Fac o Coe icien P alue OR 95% CI
Gende 0,070 0.828 - -
Longe disease du a ion
(≤ 10 yea s s. > 10 yea s)
-1.161 < 0.001 0.349 0.165-0.596
Disease beha io -0,312 0.349 - -
Concomi an AZA/me ho exa e use 0.710 0.05 2.03 1.001-4.168
S e oid use -0,438 0.184 - -
The coe icien is equi alen o he na u al log o he OR; p alue: le el o signi icance;
OR: odds a io; 95% CI: 95% con idence in e al.

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ion, and was diagnosed wi h ec al ca cinoma esul ing in
mul iple mesen e ial adenoca cinoma me as ases. The
pa ien died a ew mon hs a e he diagnosis. The hi d
malignan solid umo obse ed in his coho was a lung
cance . The pa ien was diagnosed 4 mon hs a e he s a
o induc ion he apy, al hough ches X- ays ob ained p io
o he s a o IFX induc ion he apy did no show any e i-
dence o solid umo . Ini ially, he pa ien was obse ed
o e e , a bad cough and swelling o lowe ex emi ies.
Compu e omog aphy o he ches e ealed he umo ,
which was diagnosed his ologically as a squamous cell
ca cinoma. The o e all mo ali y a e was 0.82% (0.137/
100 pa ien s-yea s).
Discussion
The esul s o his obse a ional s udy o CD pa ien s
ea ed a ele en Gas oen e ology Cen e s in Hunga y
con i m he e icacy o IFX induc ion he apy epo ed in
p e ious in es iga ions [5,6]. Da a collec ion was pa ially
e ospec i e which was one o he limi a ions o he
s udy. Al hough, all cen e s had o ha e collec some da a
ega ding hei pa ien s because o inancial equi emen .
These kinds o da a we e collec ed in he e ospec i e and
p ospec i e phase also.
O e all esponse and emission a es obse ed in his
s udy we e 86% and 46%, espec i ely. No ably, he
esponse a e was highe among younge pa ien s, and in
pa ien s wi h a sho e du a ion o CD. Among pa ien s
wi h pe ianal and en e o aginal is ulas a high esponse
a e we e obse ed a e IFX he apy, which is in conco d-
ance wi h p e iously epo ed da a [7,8].
Highe esponse and emission a es a e induc ion IFX
he apy we e obse ed in pa ien s ecei ing concomi an
he apy wi h immunosupp essan s. In Hunga y AZA is he
mos commonly used immunosupp essan . Gi en ha
he e a e li le da a on co-adminis a ion o o he immu-
nosupp essan s would imp o e he he apeu ic bene i s o
IFX in CD [9], we conclude ha AZA would be an app o-
p ia e i s choice [10]. In he p esen s udy ea ly esponse
was highe in pa ien s wi h concomi an AZA, while
emission a es a week 12 we e highe in pa ien s ecei -
ing s e oids. The combined e ec o he wo d ugs was no
in es iga ed. In addi ion sho e disease du a ion was
associa ed wi h a highe esponse and emission a e in a
logis ic eg ession analysis. Recen esul s in SONIC s udy
con i ms ou expe iences, bu only in AZA naï e pa ien s
[11]. In con as , disease loca ion o beha io we e no
independen p edic o s o ea ly esponse o emission.
Based on ou expe ience IFX he apy was e ec i e he apy
o pa ien s wi h me as a ic CD o in ac able skin mani-
es a ions. In some cases we achie ed signi ican imp o e-
men o he symp oms, in acco dance wi h esul s
obse ed by o he s [12].
Based on he u he da a collec ion a single induc ion IFX
he apy may main ain he emission in a ela i ely high
p opo ion o pa ien s wi h luminal disease [13].
The mos common ad e se e en s we e alle gic eac ions.
In ou Gas oen e ology Cen e s, s e oid p e-medica ion
was no ou inely adminis e ed a he ini ia ion o induc-
ion he apy. Howe e , in case o alle gic eac ions e-
ea men was a emp ed applying pa en e al co icos e -
oid adminis a ion and slowe in usion a e o IFX acco d-
ing o ecommenda ions o Sandbo n e al. [14]. Fa el e
al. [15] ound lowe an i-in liximab an ibody (ATI) o -
ma ion a e in a enous hyd oco isone p e-medica ion.
Based on hese indings and ou expe ience, egula s e -
oid p e-medica ion emains ques ionable when egula
immunosupp essan he apy is adminis e ed in pa allel.
Two pa ien s despi e se e e alle gic eac ion we e u he
ea ed wi h IFX based on he ins uc ions o Dubu gue e
al [16]. Applying his me hod we we e able o con inue
main enance he apy in one pa ien , howe e in he sec-
ond pa ien , he second dilu ion se ies lead o an alle gic
eac ion.
The diagnosis o delayed ype hype sensi i i y eac ion
mus be conside ed in case o e e , muscle o join pain
and ash appea se e al weeks a e IFX he apy [17].
Inc easing he dose o immunosupp essan and in oduc-
ing co icos e oid p e-medica ion was e ec i e and sa e in
one o ou pa ien s expe iencing a delayed hype sensi i -
i y eac ion [18].
Fi e pa ien s expe ienced se ious in ec ion and all we e
ea ed wi h b oad spec um an ibio ics. One o hese
pa ien s wi h meningi is caused by Lis e ia monocy ogenes
had o be u he ea ed in in ensi e ca e uni .
In wo pa ien s ube culosis was diagnosed (0.55%, 0.09/
100-pa ien yea s). Based on ou expe ience he obse ed
ube culosis incidence is highe among pa ien s ea ed
wi h IFX and o he immuosup essi e co-medica ion han
he epo ed a e age 0.02% ube culosis incidence in
Hunga y in 2005 [19]. Tube culin skin es s we e applied
in all pa ien s be o e ini ia ing IFX he apy. Resul s o he
es s we e ha dly in e p e able because he immuniza ion
o a newbo n is obliga o y in Hunga y. I was impo an
o ake in o conside a ion he social ci cums ances and
amily his o y o he pa ien s in his si ua ion.
Gene al incidence o in ec ions was also epo ed o be
highe in IFX ea ed pa ien s [20], bu IFX ea men i sel
did no p edispose o in ec ions [21]. We conclude ha
pe o ming a ube culin es and ches x- ay should be
manda o y in all si ua ions be o e an i-TNF he apy. Fu -
he mo e, egula x- ay examina ion is sugges ed o IFX-
ea ed pa ien s in geog aphic a eas wi h high p e alence
BMC Gas oen e ology 2009, 9:66 h p://www.biomedcen al.com/1471-230X/9/66
Page 7 o 7
(page numbe no o ci a ion pu poses)
o ube culosis. O e all mo ali y a e was simila o ha
calcula ed om he da abase o he TREAT egis y [20].
Conclusion
IFX was sa e and e ec i e as induc ion he apy in his
coho o Hunga ian CD pa ien s. Based on ou expe i-
ence in 11 Gas oen e ology Cen e s in Hunga y, co-
adminis a ion o immunosupp essan he apy and
sho e disease du a ion was associa ed wi h signi ican ly
imp o ed esponse/ emission a es sugges ed in pa ien s
ecei ing IFX induc ion he apy.
Compe ing in e es s
The au ho s decla e ha hey ha e no compe ing in e es s.
Au ho s' con ibu ions
This s udy ep esen s a na ionwide expe ience conce ning
in liximab induc ion he apy in C ohn's disease. All o he
au ho s wo k e ia y e e ence cen e s which a e able o
adminis e in liximab in Hunga y. PM, PLL, GM, TM, TS,
ZC, ÁS, JC, GR, KP, MP, ZJ, AS, AG, LL, ZB, CB, IR, MZ, ZD,
IA, BH, LS, JP, FN, JL, LÚ, GM, LH, ZT collec ed da a
ega ding hei in liximab ea ed pa ien s and pa ici-
pa ed in da a p ocessing as well and manusc ip p epa a-
ion. PM, TM, GH, PK, ZT and PLL we e ac i ely
pa icipa ing in he design o he ial and da abase con-
s uc ion. S a is ical analysis was pe o med by PLL and
PM. All au ho s' e ead and app o ed he inal manu-
sc ip .
Acknowledgemen s
The e was no any suppo o his obse a ional esea ch.
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