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220

SUSTAINED STEROID-FREE CLINICAL REMISSION IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE TREATED WITH ADALIMUMAB

R Panaccione¹, RA Enns², MA Kamm³, WJ Sandborn⁴, SB Hanauer⁵, PF Pollack^6
1University of Calgary, Calgary, Alberta; ²University of British Columbia, Vancouver, British Columbia; ³St Mark's Hospital, Harrow, United Kingdom; ⁴Mayo Clinic, Rochester, Minnesota, ⁵University of Chicago, Illinois; ⁶Abbott Laboratories, Parsippany, New Jersey, USA

AIM: To assess the efficacy of adalimumab (ADA) in the long-term maintenance of remission in patients with Crohn's disease (CD) without continued corticosteroid use in CHARM, the largest and longest study of adalimumab for the treatment of moderate to severe CD to date.
METHODS: In CHARM, a Phase III, double-blind, placebo-controlled study of ADA in patients with CD, patients with active CD (CDAI 220-450) received open-label induction with ADA 80 mg at Wk 0 (BL) and 40 mg at Wk 2. At Wk 4, all patients were randomized to receive placebo (PBO) or ADA 40 mg, every other week (EOW) or weekly (W), through Week 56. Randomized responders were classified as those with clinical response, a CDAI decrease =>70 from BL (CR-70). At the discretion of the investigators, patients in clinical remission (CDAI<150) were permitted to have their steroid dosages tapered beginning at/after Wk 8. The proportion of patients in clinical remission at Wks 26 and 56 who had been off steroid therapy for =>90 days was calculated for each treatment arm.
RESULTS: Patient BL characteristics were similar across arms: mean CDAI, 313; corticosteroid use, 44%. Of 854 patients receiving induction therapy, 778 patients were randomized at Wk 4. Of these, 499 (58%) had achieved CR-70 (randomized responders). Substantial percentages of randomized responders who were in clinical remission at Wks 26 and 56 had been able to discontinue steroids for =>90 days (Table).
Randomized Responders with Steroid-Free Remission for => 90 Days                     

Week	PBO  N=66	ADA 40 mg EOW N=58	ADA 40 mg W N=74
26	2 (3%)	11 (19%) *	11 (15%) *
56	3 (5%)	17 (29%) *	15 (20%) *
* p<0.05 vs. PBO.


CONCLUSION: Adalimumab therapy allowed a significant percentage of patients with moderate to severe CD to maintain steroid-free remission at both Wk 26 and Wk 56.
Funded by Abbott Laboratories