Work

Adalimumab Therapy reduces the presence of Extraintestinal Manifestations in patients with Crohnʼs Disease: The CARE Trial

Year: 2009

Type: article

Abstract: Adalimumab, a fully human anti-tumor necrosis factor (anti-TNF) monoclonal antibody, is approved for the treatment of Crohn's disease (CD) and has been shown to induce and maintain remission in patients with CD. CD is associated with extraintestinal manifestations (EIMs) in approximately 25% of patients.1 The effect of adalimumab on EIMs in a large clinical trial of patients with moderate to severe CD has not been reported previously. In CARE (Crohn's Patients Treated With Adalimumab: Results of a Safety and Efficacy Study), we evaluated efficacy and safety of adalimumab in a large population of patients whose treatment approximated usual clinical practice. Patients with Harvey-Bradshaw Index (HBI) scores ≥7 enrolled in this multicenter, open-label, European, Phase IIIb trial. Patients received induction therapy of 160-mg/80-mg adalimumab at Weeks 0/2, followed by adalimumab 40-mg every-other-week maintenance therapy through at least Week 20 (patients with flares/nonresponse could receive 40 mg weekly at/after Week 12). The presence of EIMs at baseline was evaluated clinically as part of the physical examination, and healing or development of new EIMs was evaluated at each study visit through Week 20. Data were analyzed using last-observation-carried-forward (LOCF) methodology. The sign test was used to compare incidences of EIMs at baseline and Week 20. Of the 945 patients enrolled in CARE, 60% were women, 98% were white, and median age was 34 years. At least 1 EIM was reported in 53% of patients at baseline, with arthralgia (47%), arthritis (9%), and oral aphthous ulcers (5%) being the most common (table). The overall incidence of EIMs was 30% at Week 20, and 51% of patients with at least 1 EIM at baseline were completely EIM-free at Week 20. Adalimumab therapy was effective in reducing the presence of many EIMs in patients with CD.

Source: Inflammatory Bowel Diseases

DOI: 10.1097/00054725-200912002-00126