Concomitant Use of Adalimumab and Immunomodulators or Corticosteroids Compared with Adalimumab Alone: Pooled Safety Analysis: 2010 Presidential Poster

Abstract

Purpose: To assess the incidence of serious infections in patients with Crohn's disease (CD) using adalimumab in combination with immunomodulators and/or corticosteroids. Methods: The proportion of patients with treatment-emergent serious infections was determined from the cumulative adverse event data in lead-in and long-term studies of adalimumab in CD (CLASSIC I and II, CHARM, GAIN, and ADHERE) among patients who received at least 1 dose. Proportions and rates of serious infection were assessed across treatment groups according to receipt of immunomodulators (IMM, i.e., 6-MP, AZA, and methotrexate) and/or corticosteroids at lead-in study baseline. Proportions were compared using Fisher's exact test. Results: In the pooled analysis, serious infection occurred in 10.0% (64/638) of patients using IMM in combination with adalimumab compared with 7.2% (59/821) of patients using adalimumab without IMM (p=0.058). In both groups, baseline use of corticosteroid was associated with increased serious infections (see Table). Within the subgroup receiving adalimumab without IMM, corticosteroid use was associated with a significantly increased proportion of patients with serious infections compared with adalimumab alone (p=0.034). Serious infections were observed most commonly in patients receiving adalimumab plus both IMM and corticosteroids (p=0.005, compared with adalimumab alone). Conclusion: Patients with Crohn's disease treated with corticosteroids and IMMs in combination with adalimumab are at the highest risk of experiencing treatment-emergent serious infections. Disclosure: Dr Sandborn - Consultant, research support: Abbott Dr Colombel - Consultant: Abbott Dr Lewis - Consultant: Abbott Dr Osterman - Consultant: Abbott Dr Robinson - Employee, Abbott Dr Huang - Employee, Abbott Dr Pollack - Employee, Abbott Dr Thakkar - Employee, Abbott.Table: Treatment-emergent serious infections by baseline concomitant therapy