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102

SAFETY OF ADALIMUMAB MAINTENANCE THERAPY IN CROHN’S DISEASE (CD): OPEN-LABEL FOLLOW-UP OF THE GAIN AND CHARM TRIALS

R Panaccione¹, JF Colombel², P Rutgeerts³, WJ Sandborn⁴, W Lau⁵, KG Lomax⁵, PF Pollack^5
1Health Science Centre, Calgary, Alberta; ²Hepatogastroenterology, CHU Lille, Lille, FR; ³University Hospital of Gasthuisberg, Leuven, BE; ⁴Mayo Clinic, Rochester, MN, USA; ⁵Abbott, Parsippany, NJ, USA

AIM: To evaluate adalimumab (ADA) safety in patients (pts) with CD who completed one of two Phase III, double-blind, placebo-controlled trials-CHARM [56-wk induction/maintenance] or GAIN [4-wk induction following infliximab failure]-in an open-label extension (OLE) trial. Indicated for adults with moderately to severely active CD who have failed conventional therapy or lost response/are intolerant to infliximab, ADA has demonstrated efficacy and safety in pts with or without prior anti-TNF use.^1-3
METHODS: Patients had active CD (CDAI 220-450) and were naïve to anti-TNF therapy (approximately 50% of 854 CHARM pts) or had lost response to/were intolerant of prior infliximab. Safety was routinely assessed throughout the CHARM and GAIN trials and the 1-year OLE, and data compiled for 2 years or 1 year since the start of CHARM or GAIN, respectively. Adverse events (AEs) were tabulated per 100-patient-years (E/100-PYs).
RESULTS: In all, 1,169 pts were exposed to ADA in CHARM (N=854) or GAIN (N=315). The table lists AEs of interest. Of 28 opportunistic infections, 27 were non-systemic candidiasis, with 1 case of coccidiodomycosis. Of 21 malignant AEs, 11 were skin cancers and 1 was a lymphoma; the remainder varied in type.
Adverse Events: GAIN/CHARM and OLE Combined (N=1,169; 1,299 PYs)                                                        

Adverse Event (AE)	Patients n (%)	Events (E/100-PYs)
Any AE	1,104 (94.4)	9,979 (768.1)
Any serious AE	288 (24.6)	456 (35.1)
AE leading to discontinuation	224 (19.2)	284 (21.9)
Infectious AE	705 (60.3)	1,793 (138.0)
Serious infectious AE	70 (6.0)	82 (6.3)
Injection site reactions	238 (20.4)	388 (29.9)
Opportunistic infectious AE	24 (2.1)	28 (2.2)
Tuberculosis	3 (0.2)	3 (0.2)
Malignant neoplasms AE	20 (1.7)	21 (1.6)
Fatal AE	2 (0.2)	2 (0.2)

CONCLUSIONS: ADA was well-tolerated in this analysis, with a safety profile consistent with those in previous ADA clinical trials for CD and other indications.
REFERENCES: 1. Sandborn WJ, et al. Ann Intern Med. 2007;146:829-838.
2. Colombel JF, et al. Gastroenterology. 2007;132:52-65.
3. Schiff MA, et al. Ann Rheum Dis. 2006;65:889-894.
Funded by Abbott Laboratories.

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