Background: The treatment of moderate-severe Crohn's disease is difficult and approximately 20% of patients do not respond to conventional therapy, including corticosteroids and immunosuppressive drugs. Infliximab is a treatment of proven efficacy in this group of patients. It is not clear which variables predict a good response. Aims: To evaluate in a large series of patients (pts) with acute steroid resistant Crohn's Disease or fistulating disease the role of Infliximab looking at the predictors of response. Patients and Methods: 573 pts (265 men, 308 women) with steroid dependent/resistant moderate severe Crohn's disease (CDAI > 220-400) (312 pts) or with fistulating disease (190 pts) or both of them (71 pts) (perianal 72%, enterocutaneous 11%, others 17%) in 12 Italian referral centers were treated with a dose of 5 mg per kg of body weight. In dependant/resistant steroid disease one single or 3 infusions were given whereas in fistulating disease 3 infusions (at 0,2,6 weeks) were given. Primary endpoints were: (a) clinical response, defined as a reduction of 70 or more points in the score on the Crohn's disease activity index at 12 weeks after first infusion and clinical remission, defined as CDAI < 150 in pts with steroid/dependant patients; (b) reduction of at least 50% of the number of fistulas or complete closure of fistulas in pts with fistulating disease. The following variables were evaluated in a univariable analysis: sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, type of fistulas. Side effects were evaluated. Results: (a) steroid dependant/resistant disease: 94 pts (24,5%) had a clinical response and 228 pts (59,5%) reached clinical remission. (b) fistulating disease: 80 pts (30,6%) had a reduction of 50% of the number of fistulas and in 107 pts (41%) a total closure of fistulas was observed. For luminal disease previous surgery predicted a worse response (OR 0.54, CI 0.296-0.975); for fistulating disease other fistulas responded less than perianal fistulas (0.57, CI 0.303-1,097). No serious side effects were observed. Conclusion: Infliximab is effective in steroid dependant/resistant patients and in fistulating disease. Previous surgery and other fistulas predicted a worse response in luminal and fistulating disease respectively.

Orlando, A., Colombo, E., Kohn, A., Biancone, L., Viscido, A., Sostegni, R., et al. (2004). Infliximab in the treatment of steroid resistant/dependant and fistulating Crohn's disease: An analysis of predictors of response in a italian multicentric open study in 573 patients. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 8(5), 230-230.

Infliximab in the treatment of steroid resistant/dependant and fistulating Crohn's disease: An analysis of predictors of response in a italian multicentric open study in 573 patients

BIANCONE, LIVIA;
2004-01-01

Abstract

Background: The treatment of moderate-severe Crohn's disease is difficult and approximately 20% of patients do not respond to conventional therapy, including corticosteroids and immunosuppressive drugs. Infliximab is a treatment of proven efficacy in this group of patients. It is not clear which variables predict a good response. Aims: To evaluate in a large series of patients (pts) with acute steroid resistant Crohn's Disease or fistulating disease the role of Infliximab looking at the predictors of response. Patients and Methods: 573 pts (265 men, 308 women) with steroid dependent/resistant moderate severe Crohn's disease (CDAI > 220-400) (312 pts) or with fistulating disease (190 pts) or both of them (71 pts) (perianal 72%, enterocutaneous 11%, others 17%) in 12 Italian referral centers were treated with a dose of 5 mg per kg of body weight. In dependant/resistant steroid disease one single or 3 infusions were given whereas in fistulating disease 3 infusions (at 0,2,6 weeks) were given. Primary endpoints were: (a) clinical response, defined as a reduction of 70 or more points in the score on the Crohn's disease activity index at 12 weeks after first infusion and clinical remission, defined as CDAI < 150 in pts with steroid/dependant patients; (b) reduction of at least 50% of the number of fistulas or complete closure of fistulas in pts with fistulating disease. The following variables were evaluated in a univariable analysis: sex, age at diagnosis, smoking habit, site of disease, previous surgery, extraintestinal manifestations and concomitant therapies, type of fistulas. Side effects were evaluated. Results: (a) steroid dependant/resistant disease: 94 pts (24,5%) had a clinical response and 228 pts (59,5%) reached clinical remission. (b) fistulating disease: 80 pts (30,6%) had a reduction of 50% of the number of fistulas and in 107 pts (41%) a total closure of fistulas was observed. For luminal disease previous surgery predicted a worse response (OR 0.54, CI 0.296-0.975); for fistulating disease other fistulas responded less than perianal fistulas (0.57, CI 0.303-1,097). No serious side effects were observed. Conclusion: Infliximab is effective in steroid dependant/resistant patients and in fistulating disease. Previous surgery and other fistulas predicted a worse response in luminal and fistulating disease respectively.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/12 - Gastroenterologia
English
corticosteroid; immunosuppressive agent; infliximab; steroid; article; clinical trial; controlled clinical trial; controlled study; Crohn disease; data analysis; disease activity; disease classification; disease severity; drug efficacy; drug infusion; drug response; human; Italy; major clinical study; multicenter study; outcomes research; prediction; remission; scoring system; smoking habit; statistical analysis
Orlando, A., Colombo, E., Kohn, A., Biancone, L., Viscido, A., Sostegni, R., et al. (2004). Infliximab in the treatment of steroid resistant/dependant and fistulating Crohn's disease: An analysis of predictors of response in a italian multicentric open study in 573 patients. EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 8(5), 230-230.
Orlando, A; Colombo, E; Kohn, A; Biancone, L; Viscido, A; Sostegni, R; Rizzello, F; Benazzato, L; Castiglione, F; Papi, C; Meucci, G; Rigler, G; Mocciaro, F; Lavagna, A; Molten, M; Scimeca, D; Angelucci, E; Morselli, C; Geremia, A; Milite, G; Cottone, M
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/34207
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