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034

SUSTAINED CLINICAL REMISSION IN PATIENTS WITH MODERATE TO SEVERE CROHN'S DISEASE WITH ADALIMUMAB, REGARDLESS OF ANTI-TNF HISTORY OR CONCOMITANT IMMUNOSUPPRESSANT THERAPY

R Panaccione¹, RA Enns², JF Colombel³, WJ Sandborn⁴, SB Hanauer⁵, PF Pollack^6
1University of Calgary, Calgary, Alberta; ²University of British Columbia, Vancouver, British Columbia; ³CHU Lille, Lille, France; ⁴Mayo Clinic, Rochester, Minnesota; ⁵University of Chicago, Chicago, Illinois; ⁶Abbott Laboratories, Parsippany, New Jersey, USA

AIM: To evaluate the efficacy of adalimumab (ADA) in sustaining clinical remission in pts with CD with concomitant immunosuppressant (IMM) therapy or a history of anti-TNF treatment.
METHODS: In CHARM, a Phase III, double-blind, placebo-controlled study of the maintenance of clinical remission (CDAI<150) and safety of ADA, pts with active CD (CDAI 220-450) received open-label induction ADA 80 mg at Wk 0 (BL) and 40 mg at Wk 2. At Wk 4, all pts were randomized to placebo (PBO) or 40 mg ADA, every other week (EOW) or weekly (W), through Wk 56. Pts with clinical response (decrease from BL CDAI=>70 [CR-70]) at Wk 4 were classified as randomized responders (RR). The % of pts with CDAI<150, stratified by concomitant IMM use and anti-TNF history, were calculated at Wks 26 and 56.
RESULTS: Of 854 pts receiving induction therapy, 778 were randomized. Of these, 499 (58%) were RR. BL characteristics were similar across the 3 arms: mean CDAI=313; concomitant IMM use (such as AZA, 6-MP, or MTX), 47%; history of anti-TNF therapy, 50%. The table shows the proportion of RR achieving CDAI<150 at Wks 26 and 56 by history of prior anti-TNF or concomitant IMM therapy.
                                                                 

Randomized Responders in Remission by Concomitant/Prior Therapy, n/N (%)
Week	Therapy	PBO	ADA, EOW	ADA, W
26	IMM	21/131 (16)	53/136 (39) *	53/121 (44) *
	No IMM	8/39 (21)	15/36 (42)**	20/36 (56)***
	Prior anti-TNF	13/81 (16)	28/86 (33)**	30/71 (42)*
	No prior anti-TNF	16/89 (18)	40/86 (47)*	43/86 (50)*
56	IMM	15/131 (12)	50/136 (37)*	47/121 (39)*
	No IMM	5/39 (13)	12/36 (33)**	18/36 (50)*
	Prior anti-TNF	8/81 (10)	26/86 (30)***	24/71 (34)*
	No prior anti-TNF	12/89 (14)	36/86 (42)*	41/86 (48)*
*p<0.001, **p<0.05, ***p<0.01, all vs. PBO


CONCLUSIONS: Adalimumab was significantly superior to PBO for the long-term treatment of CD irrespective of concomitant IMM therapies. Prior anti-TNF therapy resulted in slightly lower remission rates, but ADA significance vs. PBO was maintained.
Funded by Abbott Laboratories