Open-label infliximab therapy in Crohn's disease: a long-term multicenter study of efficacy, safety and predictors of response

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• 作者：Yago Gonzá ; lez-Lama^a ; Antonio Ló ; pez-San Romá ; n^b ; Ignacio Marí ; n-Jimé ; nez^c ; Bego&#241 ; a Casis^d ; Isabel Vera^e ; Fernando Bermejo^f ; José ; Lá ; zaro Pé ; rez-Calle^g ; Carlos Taxonera^h ; Francisca Martí ; nez-Silva^b ; Luis Menché ; n^c ; Pilar Martí ; nez-Montiel^d ; Marta Calvo^e ; José ; Antonio Carneros^f ; Pilar Ló ; pez^g ; Juan Luis Mendoza^h ; José ; Marí ; a Milicua^b ; Alaí ; n Huerta^c ; Fernando Sá ; nchez^d ; Luis Abreu^e ; Natalia Ló ; pez-Palacios^h ; José ; Maté ; ^a ; Javier P. Gisberta^a ; ^{Spain.gisbert@meditex.es} ; on behalf of the Group for the Study of Inflammatory Bowel Diseases from Madrid (ENICMAD)
• 刊名：Gastroenterolog铆a y Hepatolog铆a
• 出版年：2008
• 期刊代码：pca167_02105705
• 类别：med
• 出版时间：July 2008
• 卷：31
• 期：7
• 页码：421-426
• 文件大小：98 K

摘要

lass="h4">Background

Efficacy of infliximab in Crohn's disease (CD) showed by randomized controlled trials must be confirmed in clinical practice. We aimed to evaluate efficacy and safety of infliximab in CD patients of the Madrid area, looking for clinical predictors of response.

lass="h4">Methods

Multicenter retrospective survey of all CD patients treated with infliximab in 8 University hospitals of the Madrid area (Spain) with a minimum follow up of 14wks.

lass="h4">Results

169 patients included (48%males, mean age 39 卤 12 yrs). 64%of them had perianal disease. 82%were under immunosuppressants. 1355 infliximab infusions administered (mean 8, range 1-30). 90%response rate and 48%remission rate were obtained with induction therapy. 73%followed maintenance treatment, and 78%of them maintained or improved the response after a mean follow up of 28 months (range 3.5-86). 24 patients lost response during the follow up, after a mean of 41wks (range 6-248). Only the prescription of maintenance therapy was predictive factor for favourable response (p < 0.01). 17 infusion reactions were reported (10%of the patients, 1.2%of the infusions; only one case was severe) and were the cause of treatment withdrawal in 7 patients. Co-treatment with immunosuppressive drugs and maintenance infliximab therapy were protective factors for infusion reactions (p < 0.05). Other adverse events occurred in 26%of the patients, and were cause of treatment withdrawal in 7 patients.

lass="h4">Conclusions

Infliximab is effective and safe for CD management but concomitant immunosuppressive drugs and maintenance treatment should be prescribed to obtain the best outcome. That confirms in a real life clinical setting the favourable results obtained in randomized clinical trials.