Adalimumab for Maintenance Treatment of Crohn's Disease: Results of the CLASSIC II Trial

¹ Mayo Clinic, United States
² University of Chicago, United States
³ University Hospital Gasthuisberg, Belgium
⁴ University of Alberta, Canada
⁵ Charles University, Czech Republic
⁶ Dalhousie University, Canada
⁷ University of Calgary, Canada
⁸ Atlanta Gastroenterology Associates, United States
⁹ Abbott Laboratories, United States

^* To whom correspondence should be addressed. E-mail: sandborn.william{at}mayo.edu.

Accepted 29 January 2007

	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.

Keywords: Crohn's disease, adalimumab, gastroenterology, randomised controlled trial, tumour necrosis factor antagonists

Relevant Article

The classics in perspective

Julián Panés and Subrata Ghosh
Gut 2007 56: 1184-1186. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

				A K Akobeng Crohn's disease: current treatment options Arch. Dis. Child., September 1, 2008; 93(9): 787 - 792. [Abstract] [Full Text] [PDF]

				G. R. Lichtenstein, R. Panaccione, and G. Mallarkey Review: Efficacy and safety of adalimumab in Crohn's disease Therapeutic Advances in Gastroenterology, July 1, 2008; 1(1): 43 - 50. [Abstract] [PDF]

				J. Hinojosa, J. Borras-Blasco, N. Maroto, J D. Rosique-Robles, R. Alos, and M. E. Castera Severe Myalgia Associated with Adalimumab Treatment in a Patient with Crohn's Disease Ann. Pharmacother., July 1, 2008; 42(7): 1130 - 1133. [Abstract] [Full Text] [PDF]

				J.-F. Colombel, A. J M Watson, and M. F Neurath The 10 remaining mysteries of inflammatory bowel disease Gut, April 1, 2008; 57(4): 429 - 433. [Full Text] [PDF]

				J. Panes and S. Ghosh The classics in perspective Gut, September 1, 2007; 56(9): 1184 - 1186. [Full Text] [PDF]

				P. Mannon GAIN for Loss: Adalimumab for Infliximab-Refractory Crohn Disease Ann Intern Med, June 19, 2007; 146(12): 888 - 890. [Full Text] [PDF]

				W. J. Sandborn, P. Rutgeerts, R. Enns, S. B. Hanauer, J.-F. Colombel, R. Panaccione, G. D'Haens, J. Li, M. R. Rosenfeld, J. D. Kent, et al. Adalimumab Induction Therapy for Crohn Disease Previously Treated with Infliximab: A Randomized Trial Ann Intern Med, June 19, 2007; 146(12): 829 - 838. [Abstract] [Full Text] [PDF]