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P368 Risk factors for serious infections in elderly patients receiving infliximab and other Crohn’s disease therapies: TREAT™ registry data

G. Lichtenstein1, W. Langholff2, B. Feagan*3, R. Cohen4, B. Salzberg5, J. Popp6, R. Nissinen7, W. J. Sandborn8

1University of Pennsylvania Perelman School of Medicine, Division of Gastroenterology, Philadelphia, Pennsylvania, United States, 2Janssen R & D, LLC, Spring House, Pennsylvania, United States, 3Robarts Clinical Trials Inc., Robarts Research Institute, University of Western Ontario, London, Ontario, Canada, 4University of Chicago Medical Centre, Department of Gastroenterology, Chicago, Illinois, United States, 5Atlanta Gastroenterology Specialists PC, Atlanta, Georgia, United States, 6Janssen Pharmaceuticals, Horsham, Pennsylvania, United States, 7Janssen Biologics BV, Leiden, Netherlands, 8University of California San Diego, Division of Gastroenterology, La Jolla, California, United States

Background

The aim of the study was to evaluate if age is an independent risk factor for serious infections (SI) in patients with Crohn’s disease (CD) using data from the TREAT registry.

Methods

TREAT, a prospective registry, was established to study the long-term safety of infliximab (IFX) and other therapies in CD. We retrospectively evaluated patient demographics (including age groups), disease characteristics, and medication regimens (IFX, prednisone [PRED], immunomodulators [IMM], and narcotic analgesics [NARC]) associated with the time to first SI using a multivariate Cox proportional hazards regression model and a univariate model just for age.

Results

In total, 6 273 pts were enrolled: 3 440 IFX-treated and 2 833 other treatments-only treated patients. To evaluate age alone as a predictor to time to first SI, patients were stratified into 4 quartiles according to age group (years): age ≤ 30 (Group 1) n = 1 480; 31 to ≤ 41, (Group 2), n = 1 669; 42 to ≤ 52 (Group 3), n = 535; and >52 (Group 4) n = 1 552. Median age from youngest to oldest quartile was 25, 36, 47, and 60, respectively. Baseline demographics and disease characteristics were generally comparable across all 4 age groups; IMM use was lowest in the oldest age group (33.2%) vs the 2 youngest age groups (Group 1 = 46.4% and Group 2 = 43.7%). Fewer patients with moderate-to-severe disease activity were found in the oldest age group (17.2%) vs the youngest age group (24.8%). Duration and severity of disease, PRED use, NARC use, and IFX use were all identified as significant factors in patients developing SI based on the multivariate analysis; age group was not associated. To further explore the effect of age, a univariate model including age group as a factor was run separately for each treatment group (Table 1). A significantly increased risk was observed in time to SI for IFX-treated patients in Group 4 vs Group 1, HR 1.60 (1.15, 2.22, p = 0.005); this observation was not seen in a similar comparison with the non-IFX-treated patients: HR 0.774 (0.39, 1.532, p = 0.462). SI rates were similar in each age group stratified by the number of infusions.

Conclusion

Based on the results of this analysis, age group was not a risk factor in time to first SI when both IFX and non-IFX patients were considered together. However, an increased risk of SI was observed with age when examined in patients on IFX.

Table 1. Serious infections in TREAT registry stratified by age groups

TREAT01