Adalimumab for maintenance treatment of Crohn’s disease: results of the CLASSIC II trial
- W J Sandborn1,
- S B Hanauer2,
- P Rutgeerts3,
- R N Fedorak4,
- M Lukas5,
- D G MacIntosh6,
- R Panaccione7,
- D Wolf8,
- J D Kent9,
- B Bittle10,
- J Li10,
- P F Pollack10
- 1Mayo Clinic, Rochester, MN, USA
- 2University of Chicago, Chicago, IL, USA
- 3Universitaire Ziekenhuizen Leuven, UZ Gasthuisberg, Leuven, Belgium
- 4University of Alberta, Edmonton, Alberta, Canada
- 5Charles University, Prague, Czech Republic
- 6Dalhousie University, Halifax, Nova Scotia, Canada
- 7University of Calgary, Calgary, Alberta, Canada
- 8Atlanta Gastroenterology Associates, Atlanta, GA, USA
- 9Abbott Laboratories, Abbott Park, Illinois, USA
- 10Abbott Laboratories, Parsippany, New Jersey, USA
- Correspondence to:
Dr William J Sandborn
Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA;
- Accepted 29 January 2007
- Revised 25 January 2007
- Published Online First 13 February 2007
Background: Adalimumab induced clinical remission after four weeks in patients with active Crohn’s disease in the CLASSIC I trial.
Objective: To evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn’s disease in a follow-on randomised controlled trial (CLASSIC II).
Methods: In the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn’s disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week, 40 mg weekly, or placebo for 56 weeks. Patients not in remission at both weeks 0 and 4 were enrolled in an open-label arm and received adalimumab 40 mg every other week. With non-response or flare, these patients could have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare could switch to open-label adalimumab 40 mg every other week and again to 40 mg weekly. The primary end point 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 every other week and 83% who received 40 mg weekly were in remission at week 56, v 44% for placebo (p<0.05). In all, 204 patients entered the open-label arm. Of these, 93 (46%) were in clinical remission at week 56. Adalimumab was generally well-tolerated in all patients.
Conclusions: Adalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe Crohn’s disease naive to anti-TNF treatment.
- ANA, antinuclear antibodies
- CDAI, clinical disease activity index
- CLASSIC: Clinical Assessment of Adalimumab Safety and Efficacy Studied as Induction Therapy in Crohn’s Disease trial
- IBDQ, inflammatory bowel disease questionnaire
- LOCF, last observation carried forward
- Crohn’s disease
- tumour necrosis factor antagonists
- randomised controlled trial
Published online first 13 February 2007
Funding: This study was funded by a research grant from Abbott Laboratories, Abbott Park, Illinois, USA. It was designed by two of the investigators who are authors of this manuscript (WJS, SBH), as well as Abbott Laboratories staff members. Selected investigators and Abbott staff members, including those who designed the study, analysed, and interpreted the data, wrote this manuscript, and agreed to submit this manuscript for publication. All authors, including the principal investigator (WJS), approved the content of the manuscript prior to submission.