Background: Aim was to assess the long-term clinical efficacy of infliximab therapy in patients with Crohn’s disease treated in a cohort of 2 tertiary referral centers in the Netherlands.
Methods: All consecutive patients with Crohn’s disease treated with infliximab were assessed. Endpoints were primary clinical efficacy, sustained benefit, efficacy of retreatment, surgical intervention rates, and safety. Sustained benefit was determined by Kaplan–Meier analysis. The estimated 5-year benefit was calculated.
Results: A total of 469 patients were included. Median follow-up length was 4.5 years (interquartile range, 2.7–6.8). Seventy patients (15%) had unsuccessful remission induction, and 316 patients received maintenance therapy. Scheduled maintenance regimen was successful in 169 of 276 (61%). Episodic maintenance therapy was successful in 19 of 40 patients (48%). Estimated 5-year sustained benefit was 55.7% (95% confidence interval, 48.8–62.6). Concomitant thiopurines were associated with improved sustained benefit. A second course of infliximab after previous discontinuation was prescribed in 131 patients with similar efficacy rates. Abdominal surgical intervention rate per 100 patient-years was significantly reduced after infliximab initiation in patients with a scheduled maintenance regime (reduction, 2.70; 95% confidence interval, −4.82 to −0.35; P = 0.018). Mortality and malignancy rates were 1.9% (0.39/100 patient-years) and 3.4% (0.70/100 patient-years), respectively.
Conclusions: The present study shows an estimated 5-year sustained benefit of 55.7% in patients with Crohn’s disease treated with infliximab maintenance therapy. Remission induction and maintenance were equally successful in patients starting infliximab and patients who temporarily stopped and were retreated. Long-term use of infliximab was safe and reduced the need for surgery in patients on scheduled maintenance therapy.
Article first published online 2 April 2013
*Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam, The Netherlands;
†Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands;
‡Department of Gastroenterology and Hepatology, Free University Medical Centre, Amsterdam, The Netherlands; and
§Department of Gastroenterology and Hepatology, St Lucas Andreas Hospital, Amsterdam, The Netherlands.
Reprints: Cyriel Y. Ponsioen, MD, PhD, Department of Gastroenterology and Hepatology, Academic Medical Center, PO Box 22660, 1100 DD Amsterdam, The Netherlands (e-mail: firstname.lastname@example.org).
C.P. Peters received speaking honoraria from Abbott Inc. A.A. van Bodegraven received speaking honoraria and consultancy fees from Schering Plough, and Abbott Inc., as well as an unrestricted research grant from Schering Plough. G.R.A.M. D’Haens received consultancy fees from Abbott Laboratories, Actogenix, Centocor, Cosmo, Engene, Ferring Pharmaceuticals, GlaxoSmithKline, Jansen Biologics, Millenium Pharmaceuticals, MSD, Novonordisk, PDL Biopharma, Pfizer, SetPoint, Shire, Takeda, Teva, UCB; Research grants from Abbott Laboratories, Jansen Biologics, Given Imaging, MSD, DrFalk Pharma, Photopill; and speaking honoraria from Abbott Laboratories, Tillotts, Tramedico, Ferring, MSD, UCB, Norgine, and Shire. C.Y. Ponsioen received speakers, and consultancy honoraria, and unrestricted research grants from Schering Plough, Falk Pharma, Tramedico, Abbott Inc., and GlaxoSmithKline. The authors have no conflicts of interest to disclose.
Received October 18, 2012
Accepted November 13, 2012