Journal Article

Serious Infection and Mortality in Patients With Crohn's Disease: More Than 5 Years of Follow-Up in the TREAT™ Registry

Price, Samiyeh, Feagan, Brian G, Diamond, Robert H, Cohen, Russell D, Sandborn, William J, Lichtenstein, Gary R, Salzberg, Bruce A, Langholff, Wayne, Londhe, Anil

2012

Overview

The objective of this study was to contribute long-term safety data for infliximab and other therapies in Crohn's disease (CD). We prospectively evaluated CD patients enrolled in the large, observational Crohn's Therapy, Resource, Evaluation, and Assessment Tool registry, established to compare infliximab safety with conventional nonbiological medications in CD. A total of 6,273 patients were enrolled and evaluated on or before 23 February 2010; 3,420 received infliximab (17,712 patient-years; 89.9% received ≥ 2 infusions) and 2,853 received other-treatments-only (13,251 patient-years). Mean length of patient follow-up was 5.2 years. More infliximab- than other-treatments-only-treated patients had moderate-to-severe (30.6% vs. 10.7%) or severe-to-fulminant (2.5% vs. 0.6%) disease severity (P < 0.001). In the year before enrollment, more infliximab- than other-treatments-only-treated patients required surgical intervention (17.4% vs. 13.6%), medical hospitalization (14.2% vs. 8.8%), prednisone (47.8% vs. 31.4%), immunomodulators (52.0% vs. 32.1%), and narcotic analgesics (17.3% vs. 9.1%). Patient mortality was similar for infliximab- and other-treatments-only-treated patients (0.58 vs. 0.59/100 patient-years). In multivariate logistic regression analyses, treatment with prednisone (hazard ratio (HR) = 2.14, 95% confidence interval (CI) = 1.55, 2.95; P < 0.001) or narcotic analgesics (HR = 1.79, 95% CI = 1.29, 2.48; P < 0.001) and age (HR = 1.08, 95% CI = 1.07, 1.09; P < 0.001) were associated with increased mortality risk. Neither infliximab nor immunomodulator treatment was associated with increased mortality risk. Factors independently associated with serious infections included moderate-to-severe disease activity (HR = 2.24, 95% CI = 1.57, 3.19; P < 0.001), narcotic analgesic treatment (HR = 1.98, 95% CI = 1.44, 2.73; P < 0.001), prednisone therapy (HR = 1.57, 95% CI = 1.17, 2.10; P = 0.002), and infliximab treatment (HR = 1.43, 95% CI = 1.11, 1.84; P = 0.006). Mortality was similar between infliximab- and other-treatments-only-treated CD patients. An increased risk of serious infection with infliximab was observed, although CD severity and use of prednisone or narcotic analgesics carried higher risks.

• Publisher: Nature Publishing Group,Wolters Kluwer Health Medical Research, Lippincott Williams & Wilkins
• Subject: Adult / Antibodies, Monoclonal - adverse effects / Antibodies, Monoclonal - therapeutic use / Biological and medical sciences / Crohn Disease - drug therapy / Crohn Disease - mortality / Female / Follow-Up Studies / Gastroenterology / Gastroenterology. Liver. Pancreas. Abdomen / Gastrointestinal Agents - adverse effects / Gastrointestinal Agents - therapeutic use / Humans / Immunosuppressive Agents - adverse effects / Immunosuppressive Agents - therapeutic use / Infection - epidemiology / Inflammatory Bowel Disease / Infliximab / Male / Medical sciences / Middle Aged / Other diseases. Semiology / Prednisone - adverse effects / Prednisone - therapeutic use / Prospective Studies / Registries / Severity of Illness Index / Stomach. Duodenum. Small intestine. Colon. Rectum. Anus / Treatment Outcome