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.
- Crohn's disease
- randomised controlled trial
- tumour necrosis factor antagonists
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William Sandborn, Paul Rutgeerts, Douglas Wolf, and Remo Panaccione have served as consultants for Abbott Laboratories. William Sandborn, Stephen Hanauer, Paul Rutgeerts, and Remo Panaccione have participated in continuing medical education events supported by unrestricted educational grants from Abbott Laboratories. Jeffrey Kent, Barry Bittle, Ju Li, and Paul Pollack are Abbott employees.