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INDUCTION OF REMISSION WITH ADALIMUMAB IN PATIENTS WITH MODERATE CROHN'S DISEASE: SUBANALYSIS OF CLASSIC I
W Sandborn1, J Colombel2, M Castillo3, Q Zhou3, R Thakkar31University of California, San Diego, La Jolla, Califonria, USA; 2Centre Hospitalier Univ de Lille, Lille, France; 3Abbott Laboratories, Abbott Park, Illinois, USA
Aims: CLASSIC I (1) a randomized, double-blind, placebo-controlled, dose-ranging trial, demonstrated that adalimumab (ADA) 160 mg at week 0, followed by 80 mg at week 2 is the optimal induction regimen in anti-TNF-na´ve patients with moderate to severe Crohn's disease (CD). It also showed that patients with baseline C-reactive protein (CRP) concentration >=10mg/L achieved higher rates of clinical remission (CDAI score <150) at week 4.
Methods: This post hoc analysis evaluated efficacy in patients with moderate CD (baseline CDAI =<300) and whether elevated (CRP >=10 mg/L) in this subgroup would similarly improve efficacy, compared with results for patients with severe CD. Clinical remission at week 4 was assessed for patients who received induction with ADA (160 mg/80 mg or 80 mg/40 mg) or placebo in CLASSIC I. Patients with the following characteristics were included in the analysis: baseline CRP >=10 mg/L; moderate CD (baseline CDAI =<300); moderate CD with baseline CRP >=10 mg/L; severe CD (baseline CDAI >300); and severe CD with baseline CRP >=10 mg/L.
Results: A greater proportion of patients treated with ADA induction (160 mg/80 mg) achieved clinical remission compared with patients treated with placebo (Table). The highest efficacy was seen in patients with moderate CD and elevated baseline CRP, with more than half achieving clinical remission after induction with ADA 160 mg/80 mg.
Conclusions: In CLASSIC I, ADA 160 mg/80 mg was effective at inducing remission in all subgroups studied, including the subgroup of patients with moderate CD; in this subgroup, high baseline CRP was associated with substantially higher remission rates. This analysis suggests that patients with moderate disease can be treated effectively with adalimumab, especially when there is evidence of inflammation. Prospective studies are warranted to confirm these findings.
Reference: 1. Hanauer SB, et al. Gastroenterology. 2006;130:323-33.