Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe--a Hungarian nationwide observational study.
BACKGROUND
Infliximab (IFX) has proven to be an effective addition to the therapeutic arsenal for refractory, fistulizing, and steroid dependent Crohn's disease (CD), with efficacy in the induction and maintenance of clinical remission of CD. Our objective in this study is to report the nationwide, multicenter experience with IFX induction therapy for CD in Hungary.


METHODS
During a 6-year-period, beginning in 2000, a total of 363 CD patients were treated with IFX as induction therapy (5 mg/kg IFX infusions given at week 0, 2 and 6) at eleven centers in Hungary in this observational study. Data analysis included patient demographics, important disease parameters and the outcome of IFX induction therapy.


RESULTS
Three hundred and sixty three patients (183 women and 180 men) were treated with IFX since 2000. Mean age was 33.5 +/- 11.2 years and the mean duration of disease was 6.7 +/- 6.1 years. The population included 114 patients (31.4%) with therapy-refractory CD, 195 patients (53.7%) with fistulas, 16 patients (4.4%) with both therapy-refractory CD and fistulas, and 26 patients (7.2%) with steroid dependent CD. Overall response rate was 86.2% (313/363). A higher response rate was observed in patients with shorter disease duration (p = 0.05, OR:0.54, 95%CI:0.29-0.99) and concomitant immunosuppressant therapy (p = 0.05, OR: 2.03, 95%CI:0.165-0.596). Concomitant steroid treatment did not enhance the efficacy of IFX induction therapy. Adverse events included 34 allergic reactions (9.4%), 17 delayed type hypersensitivity (4.7%), 16 infections (4.4%), and 3 malignancies (0.8%).


CONCLUSIONS
IFX was safe and effective treatment in this cohort of Hungarian CD patients. Based on our experience co-administration of immunosuppressant therapy is suggested in patients receiving IFX induction therapy. However, concomitant steroid treatment did not enhanced the efficacy of IFX induction therapy.
Miheller
Pál
P
2nd Department of Medicine, Semmelweis University, Budapest, Hungary. mihpal@yahoo.co.uk
Lakatos
Péter L
PL
Horváth
Gábor
G
Molnár
Tamás
T
Szamosi
Tamás
T
Czeglédi
Zsófia
Z
Salamon
Agnes
A
Czimmer
József
J
Rumi
György
G
Palatka
Károly
K
Papp
Mária
M
Jakab
Zsolt
Z
Szabó
Andrea
A
Gelley
András
A
Lakatos
László
L
Barta
Zsolt
Z
Balázs
Csaba
C
Rácz
István
I
Zeher
Margit
M
Döbrönte
Zoltán
Z
Altorjay
István
I
Hunyady
Béla
B
Simon
László
L
Papp
János
J
Banai
János
J
Nagy
Ferenc
F
Lonovics
János
J
Ujszászy
László
L
Muzes
Györgyi
G
Herszényi
László
L
Tulassay
Zsolt
Z
D000328:Adult; D000893:Anti-Inflammatory Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D000911:Antibodies, Monoclonal / Q000009:adverse effects* / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006814:Hungary; D006967:Hypersensitivity / Q000209:etiology; D000069285:Infliximab; D016015:Logistic Models; D008137:Longitudinal Studies; D008297:Male; D012074:Remission Induction; D012189:Retrospective Studies; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D000069285:Infliximab