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Open Access Research article

Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe - a Hungarian nationwide observational study

Pál Miheller1*, Péter L Lakatos2, Gábor Horváth3, Tamás Molnár4, Tamás Szamosi5, Zsófia Czeglédi5, Ágnes Salamon6, József Czimmer7, György Rumi7, Károly Palatka8, Mária Papp8, Zsolt Jakab9, Andrea Szabó10, András Gelley11, László Lakatos12, Zsolt Barta13, Csaba Balázs11, István Rácz10, Margit Zeher13, Zoltán Döbrönte9, István Altorjay8, Béla Hunyady7, László Simon6, János Papp2, János Banai5, Ferenc Nagy4, János Lonovics4, László Újszászy3, Györgyi Műzes1, László Herszényi1 and Zsolt Tulassay1

Author Affiliations

1 2nd Department of Medicine, Semmelweis University, Budapest, Hungary

2 1st Department of Medicine, Semmelweis University, Budapest, Hungary

3 1st Department of Medicine, Semmelweis Hospital, Miskolc, Hungary

4 1st Department of Medicine, Faculty of Medicine, University of Szeged, Szeged, Hungary

5 Department of Internal Medicine, National Medical Center, Budapest, Hungary

6 2nd Department of Internal Medicine, Balassa János Hospital, Szekszárd, Hungary

7 1st Department of Medicine, University of Pécs, Faculty of Medicine, Pécs, Hungary

8 2nd Department of Medicine, University of Debrecen, Faculty of Medicine, Debrecen, Hungary

9 2nd Department of Internal Medicine, Markusovszky Hospital, Szombathely, Hungary

10 1st Department of Medicine, Petz Aladár Hospital, Győr, Hungary

11 Department of Internal Medicine, Polyclinic of the Hospitaller Brothers of St John of God, Budapest, Hungary

12 1st Department of Medicine Csolnoky Ferenc Hospital, Veszprém, Hungary

13 3rd Department of Medicine, University of Debrecen, Faculty of Medicine, Debrecen, Hungary

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BMC Gastroenterology 2009, 9:66  doi:10.1186/1471-230X-9-66

Published: 10 September 2009

Abstract

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%).

Conclusion

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.