PTU-108 Induction of remission with adalimumab in patients with moderate Crohn's disease: subanalysis of CLASSIC I: Abstract PTU-108 Table 1 (2012)

Introduction CLASSIC I, 1 a randomised, 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-naïve patients with moderate to severe Crohn's disease (CD). It also showed that patients with baseline C reactive protein (CRP) concentration ≥10 mg/l achieved higher rates of clinical remission (CDAI score &lt;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 &gt;300); and severe CD with baseline CRP≥10 mg/l. Results 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. Conclusion 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. Abstract PTU-108 Table 1 Per cent of patients in clinical remission at week 4 Placebo ADA80/40 ADA160/80 All patients 12% (9/74) 24% (18/75) 36% (27/76)† CRP ≥10 mg/l, % (n/N) 4% (1/28) 27% (9/33)* 43% (12/28)† CDAI ≤300, % (n/N) 17% (8/46) 29% (13/45) 46% (19/41)† CRP ≥10 mg/l, CDAI ≤300, % (n/N) 7% (1/15) 26% (6/23) 57% (8/14)† CDAI &gt;300, % (n/N) 4% (1/28) 17% (5/30) 23% (8/35)* CRP ≥10 mg/l, CDAI &gt;300, % (n/N) 0% (0/13) 30% (3/10) 29% (4/14) *p&lt;0.05 vs placebo. †p&lt;0.005 vs placebo. Competing interests W Sandborn: Grant/Research Support from: Centocor Ortho Biotech, Abbott Laboratories, and UCB Pharma., Consultant for: Centocor Ortho Biotech, Abbott Laboratories, UCB Pharma, and Merck (previously Schering Plough), J-F Colombel: Shareholder with: Intestinal Biotech Development, Grant/Research Support from: Astra-Zeneca, Danisco, Danone, Dysphar, Ferring, Giuliani, Lesaffre, Mapi Naxis, Ocerra Therapeutics, Roquette, Schering-Plough and UCB, Consultant for: Abbott Laboratories, ActoGeniX NV, Albireo Pharma, Astra Zeneca, Bayer Schering Pharma, Biogen Idec, Boehringer-Ingelheim, Bristol-Myers Squibb, Cellerix, Centocor, Chemocentryx, Cosmo Technologies, Danone France, Elan, Genentech, Giuliani, Given Imaging, GlaxoSmithKline, Merck, Millennium, NeoVacs, Ocerra, Otsuka American, PDL Biopharma, Pfizer, Ribo Vacs Biotech, Schering-Plough, Shire, Synta, Teva and Petah Tikva, Therakos, UCB, and Wyeth, Speaker bureau with: Abbott Laboratories, Astra Zeneca, Centocor, Elan, Falk, Ferring, Given Imaging, Otsuka American, PDL, Schering-Plough, Shire and UCB, M Castillo Shareholder with: Abbott, Employee of: Abbott, Q Zhou Employee of: Abbott, R Thakkar Shareholder with: Abbott, Employee of: Abbott. Reference 1. Hanauer SB . Gastroenterology 2006; 130 :323.