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ADALIMUMAB MAINTAINS CLINICAL REMISSION AND RESPONSE IN PATIENTS WITH ACTIVE CROHN'S DISEASE: RESULTS OF THE CHARM TRIAL

RA Enns¹, R Panaccione², JF Colombel³, WJ Sandborn⁴, SB Hanauer⁵, PF Pollack⁶
¹University of British Columbia, Vancouver, British Columbia; ²University of Calgary, Calgary, Alberta; ³CHU Lille, Lille, France; ⁴Mayo Clinic, Rochester, Minnesota, ⁵University of Chicago, Illinois, ⁶Abbott Laboratories, Parsippany, New Jersey, USA

AIM: To evaluate the efficacy of adalimumab (ADA), a fully human anti-TNF monoclonal antibody with demonstrated efficacy in the induction of remission in Crohn's disease (CD), in the maintenance of clinical remission and response.
METHODS: In this double-blind (DB), placebo-controlled, multicenter study, pts with moderately to severely active CD (CDAI 220-450) received open-label (OL) induction doses of ADA sc, 80 mg/40 mg at Wk 0 (BL)/Wk 2. All pts were randomized at Wk 4 to receive placebo (PBO) or 40 mg ADA every other wk (EOW) or 40 mg weekly (W), through Wk 56. Clinical response was defined as a decrease from BL CDAI =>70 or 100 (CR-70/100). Co-primary endpoints were remission (CDAI<150) at Wks 26 and 56 in Wk-4 responders (randomized responders [RR], CR-70). Safety was routinely assessed.
RESULTS: Characteristics at BL were similar across treatment arms; mean CDAI=313. Of 854 pts enrolled, 778 pts were randomized at Wk 4. Of these, 499 (58%) were stratified as RR. Significantly higher rates of remission and response were maintained in RR with ADA vs PBO at both Wk 26 and Wk 56 (Table). In the 4-wk OL induction period, serious adverse events (SAE) were reported in 5% of pts. In the 52-wk DB period, significantly lower rates of SAE were reported in the ADA 40 mg EOW/W treatment groups, 9% and 8% respectively, vs.15% in the PBO group (p<0.05).

Adalimumab Efficacy at Weeks 26 and 56, % of Patients

Endpoints Wk PBO (n=170) ADA 40 mg EOW (n=172) ADA 40 mg W (n=157)
Remission 26 17 40 * 47 *
56 12 36 * 41 *
CR-100 26 27 52* 52*
56 17 41 * 48 *
CR-70 26 28 54 * 56 *
56 18 43 * 49 *
* p<0.001 vs. PBO.

CONCLUSIONS: Adalimumab, EOW or W, was more effective than PBO in maintaining ADA-induced clinical remission and response in pts with moderately to severely active CD. Adalimumab was well-tolerated, with significantly lower rates of SAE with ADA maintenance compared with PBO.
Funded by Abbott Laboratories

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Adalimumab Efficacy at Weeks 26 and 56, % of Patients
Endpoints	Wk	PBO (n=170)	ADA 40 mg EOW (n=172)	ADA 40 mg W (n=157)
Remission	26	17	40 *	47 *
	56	12	36 *	41 *
CR-100	26	27	52*	52*
	56	17	41 *	48 *
CR-70	26	28	54 *	56 *
	56	18	43 *	49 *
* p<0.001 vs. PBO.