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

Pál Miheller, Péter L. Lakatos, Gábor Horváth, Tamás Molnár, Tamás Szamosi, Zsófia Czeglédi, Ágnes Salamon, József Czimmer, György Rumi, Károly Palatka, Mária Papp, Zsolt Jakab, Andrea Szabó, András Gelley, László Lakatos, Zsolt Barta, Csaba Balázs, István Rácz, Margit Zeher, Zoltán DöbrönteIstván Altorjay, Béla Hunyady, László Simon, János Papp, János Banai, Ferenc Nagy, János Lonovics, László Újszászy, Györgyi Muzes, László Herszényi, Zsolt Tulassay

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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.

Original languageEnglish
Article number1471
Pages (from-to)66
Number of pages1
JournalBMC Gastroenterology
Volume9
DOIs
Publication statusPublished - Sep 10 2009

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Crohn Disease
Observational Studies
Safety
Therapeutics
Steroids
Hungary
Immunosuppressive Agents
Infliximab
Fistula
Delayed Hypersensitivity
Hypersensitivity
Maintenance
Demography

ASJC Scopus subject areas

  • Gastroenterology

Cite this

@article{8cb073984dd7425cb0dac759681b01fd,
title = "Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe - A Hungarian nationwide observational study",
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.",
author = "P{\'a}l Miheller and Lakatos, {P{\'e}ter L.} and G{\'a}bor Horv{\'a}th and Tam{\'a}s Moln{\'a}r and Tam{\'a}s Szamosi and Zs{\'o}fia Czegl{\'e}di and {\'A}gnes Salamon and J{\'o}zsef Czimmer and Gy{\"o}rgy Rumi and K{\'a}roly Palatka and M{\'a}ria Papp and Zsolt Jakab and Andrea Szab{\'o} and Andr{\'a}s Gelley and L{\'a}szl{\'o} Lakatos and Zsolt Barta and Csaba Bal{\'a}zs and Istv{\'a}n R{\'a}cz and Margit Zeher and Zolt{\'a}n D{\"o}br{\"o}nte and Istv{\'a}n Altorjay and B{\'e}la Hunyady and L{\'a}szl{\'o} Simon and J{\'a}nos Papp and J{\'a}nos Banai and Ferenc Nagy and J{\'a}nos Lonovics and L{\'a}szl{\'o} {\'U}jsz{\'a}szy and Gy{\"o}rgyi Muzes and L{\'a}szl{\'o} Hersz{\'e}nyi and Zsolt Tulassay",
year = "2009",
month = "9",
day = "10",
doi = "10.1186/1471-230X-9-66",
language = "English",
volume = "9",
pages = "66",
journal = "BMC Gastroenterology",
issn = "1471-230X",
publisher = "BioMed Central",

}

TY - JOUR

T1 - Efficacy and safety of infliximab induction therapy in Crohn's Disease in Central Europe - A Hungarian nationwide observational study

AU - Miheller, Pál

AU - Lakatos, Péter L.

AU - Horváth, Gábor

AU - Molnár, Tamás

AU - Szamosi, Tamás

AU - Czeglédi, Zsófia

AU - Salamon, Ágnes

AU - Czimmer, József

AU - Rumi, György

AU - Palatka, Károly

AU - Papp, Mária

AU - Jakab, Zsolt

AU - Szabó, Andrea

AU - Gelley, András

AU - Lakatos, László

AU - Barta, Zsolt

AU - Balázs, Csaba

AU - Rácz, István

AU - Zeher, Margit

AU - Döbrönte, Zoltán

AU - Altorjay, István

AU - Hunyady, Béla

AU - Simon, László

AU - Papp, János

AU - Banai, János

AU - Nagy, Ferenc

AU - Lonovics, János

AU - Újszászy, László

AU - Muzes, Györgyi

AU - Herszényi, László

AU - Tulassay, Zsolt

PY - 2009/9/10

Y1 - 2009/9/10

N2 - 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.

AB - 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.

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