Remission and Clinical Response Induced and Maintained in Patients with Active Crohnʼs Disease Treated for 1-Year Open-Label with Adalimumab

Abstract

Purpose: To assess the long-term efficacy and safety of open-label (OL) therapy with fully human anti-TNF monoclonal antibody adalimumab (ADA), approved for the treatment of rheumatoid arthritis (RA), in patients (pts) with active Crohn's disease (CD). Methods: Patients with moderate to severely active CD who completed CLASSIC, a 4-week, placebo-controlled, multi-center study of ADA, were eligible to enter a long-term ADA study (CLASSIC II). All pts in CLASSIC II received ADA 40 mg sc at Week 0 and Week 2. Patients in remission (CDAI < 150) at both Week 0 (Week 4 of CLASSIC) and Week 4 were randomized to a blinded, placebo-controlled cohort (results reported elsewhere). Patients with CDAI ≥150 received OL ADA 40 mg eow for up to 1 year. CDAI and adverse events (AE) were assessed at each study visit. Rates of remission and clinical response, reductions from baseline CDAI of ≥70 (Δ70) or ≥100 (Δ100) points, were calculated. Dose escalation to 40 mg/wk was allowed for flare or persistent non-response. Results: Of 275 pts entering CLASSIC II, 220 were treated in the OL cohort. At Week 56, 44% of pts were in remission and 68%/59% achieved Δ70/Δ100 clinical response, respectively (Table). After 1 year, 134 pts (61%) remained on ADA therapy with 54% receiving ADA 40 mg eow and 46% receiving ADA 40 mg/wk. AE were mild to moderate in severity and similar to those previously reported in studies of ADA in pts with RA. Serious AE included infection (11) and CD exacerbation (10).Table: Long-Term Remission and Clinical Response (% of pts)Conclusions: Remission was induced in 44% of pts treated with OL ADA, and 69% achieved clinical response within 1 year. Improvements were long-lasting. Adalimumab was safe and well-tolerated.