Abstract

Objective: Adalimumab induced clinical remission after 4 weeks in pateints with active Crohn's disease (CD) in the CLASSIC I trial. A follow-on randomised controlled trial (CLASSIC II) evaluated long-term efficacy and safety of adalimumab maintenance therapy in CD.

Methods: In the preceding CLASSIC I trial, 299 patients with moderate to severe CD naïve to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40mg, or 160 mg/80 mg; or placebo at Weeks 0 and 2. A total of 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label (OL) adalimumab 40 mg at Weeks 0 (Week 4 of CLASSIC I) and 2. Fifty-five patients in remission at both Weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week (eow), 40 mg weekly, or placebo through 56 weeks. Patients not in remission at both Weeks 0 and 4 were enrolled in an OL arm and received adalimumab 40 mg eow. With non-response or flare, these patients were permitted to have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare were able to switch to OL adalimumab 40 mg eow and again to 40 mg weekly. Primary endpoint was maintenance of remission (CDAI<150) in randomised patients through Week 56.

Results: Of 55 patients randomised at Week 4, 79% who received adalimumab 40 mg eow and 83% who received 40 mg weekly were in remission at Week 56, vs. 44% for placebo (p<0.05). A total of 204 patients entered the OL arm. Of these, 93 (46%) were in clinical remission at Week 56. Adalimumab was generally well-tolerated in all patients.

Conclusion: Adalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe CD naïve to anti-TNF therapy.