Adalimumab Maintains Clinical Remission and Response in Patients with Active Crohnʼs Disease

Abstract

Purpose: To assess the efficacy and safety of adalimumab (ADA), a fully human anti-TNF monoclonal antibody with demonstrated efficacy in the induction of remission in Crohn's disease (CD), in the maintenance of clinical remission and response. Methods: In this double-blind (DB), placebo-controlled, multicenter study in pts with moderately to severely active CD (CDAI 220–450), pts received open-label (OL) induction doses of ADA, 80 mg at Wk 0 (BL) and 40 mg at Wk 2. All pts were randomized at Wk 4 to receive placebo (PBO) or 40 mg ADA sc, every other wk (EOW) or weekly (W), through Wk 56. Clinical response was defined as a decrease in CDAI from BL ≥70 or 100 (CR70/100). Co-primary endpoints were remission (CDAI<150) at Wk 26 and Wk 56 in Wk 4 responders (randomized responders). Pts were routinely assessed for adverse events. Results: Characteristics at BL were similar across treatment arms, with a mean CDAI of 313. Of 854 pts enrolled, 778 pts were randomized at Wk 4. Of these, 499 (58%) pts were stratified as randomized responders (primary endpoint cohort). In this cohort, significantly higher rates of remission and response were maintained with ADA vs. PBO at both Wk 26 and Wk 56 (table).TableIn the 4-wk OL induction period, serious adverse events (SAE) were reported in 5% of pts. In the 52-wk DB period, significantly lower rates of SAE were reported in the ADA 40 mg EOW/W treatment groups, 9% and 8% respectively, vs.15% in the PBO group (p < 0.05). Conclusions: Adalimumab, either 40 mg EOW or W, was more effective than PBO in maintaining ADA-induced clinical remission and response in pts with moderately to severely active CD. Adalimumab was well-tolerated, with significantly lower rates of SAE with ADA maintenance compared with PBO.