Author information

1 Department of Medicine, Division of Gastroenterology, Hospital of the University of Pennsylvania, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania.

2 Robarts Clinical Trials, Robarts Research Institute and University of Western Ontario, London, Ontario, Canada.

3 Department of Medicine, Section of Gastroenterology, University of Chicago Medical Center, Chicago, Illinois.

4 Atlanta Gastroenterology Specialists, Atlanta, Georgia.

5 Janssen Scientific Affairs, LLC., Horsham, Pennsylvania.

6 Janssen Pharmaceutical Research & Development, LLC., Spring House, Pennsylvania.

7 Division of Gastroenterology, University of California San Diego, La Jolla, California.

Abstract

BACKGROUND: The purpose of this study was to compare the long-term safety of infliximab and nonbiologic agents as Crohn's disease (CD) therapy.

METHODS: Patients with CD were prospectively evaluated in this large, observational registry.

RESULTS: Patients (n = 6273) participated in this observational registry from July 1999 through March 2012; 3440 (54.8%) received infliximab (20,971 patient-years), and 2833 (45.2%) received other treatments only (14,806 patient-years). Overall, 59,875 infliximab infusions were administered (80%, 5 mg/kg); 3006 (89.9%) patients received ≥2 infusions. Adverse events (AEs), most commonly those related to CD (eg, abdominal pain, diarrhea), and serious AEs occurred at a higher rate among infliximab-treated patients. Mortality (0.57/100 patient-years, 0.67/100 patient-years) and malignancy rates (0.69/100 patient-years, 0.71/100 patient-years) for infliximab-treated and other-treatments-only patients, respectively, were generally similar. Serious infection rates were higher for infliximab-treated (2.15/100 patient-years) than other-treatments-only patients (0.86/100 patient-years). Infliximab dose was not associated with mortality or serious infection. An increased risk of serious infection was observed with age (>52 years vs ≤30 years) when examined in infliximab-treated patients. Nonserious cerebrovascular accidents (13 events, 0.06/100 patient-years; 5 events, 0.03/100 patient-years) and pulmonary embolisms (11 events, 0.05/100 patient-years; 4 events 0.03/100 patient-years) also occurred at higher rates among infliximab-treated patients than other-treatments-only patients.

CONCLUSIONS: Through more than 13 years of registry experience and an overall median duration of patient follow-up >6 years, mortality was similar between the infliximab-treated and other-treatments-only groups. These final cumulative results are representative of real-world experience among infliximab-treated patients with CD and are consistent with the known risks of disease activity and tumor necrosis factor antagonist therapy.