Adalimumab Induced and Maintained Clinical Remission in Patients with Crohnʼs Disease Independent of Baseline CRP Concentration

Abstract

Purpose: To evaluate the association of baseline CRP concentrations with induction and maintenance of clinical remission with anti-TNF adalimumab (ADA) therapy in patients with active Crohn's disease (CD) in the CHARM study. Methods: In CHARM, a Phase III, double-blind, placebo-controlled study of remission and safety of ADA therapy in patients with active moderate to severe CD (CDAI 220–450), all patients received open-label induction dosages of ADA, 80 mg at Wk 0 (BL) and 40 mg at Wk 2. At Wk 4, all patients were randomized to receive placebo (PBO) or 40 mg ADA sc, every other week (EOW) or weekly (W), through Week 56. Those randomized with a clinical response of ≥70 decrease from BL CDAI (CR70) at Wk 4 were classified as randomized responders. Patients in clinical remission (CDAI < 150) at Wks 26 and 56 were stratified by baseline CRP concentrations (< 1 mg/dL vs. ≥1 mg/dL). Results: Baseline characteristics were similar across treatment arms, with mean CDAI = 313 and median CRP = 0.9 mg/dL. Of 854 patients who received induction therapy, 778 were randomized. Of these, 449 (58%) had achieved CR70 at Wk 4. Clinical remission in randomized responders by baseline CRP concentration is presented in the table.Table: Remission Rates by Baseline CRP, n/N (%).Conclusions: Adalimumab induced and maintained remission over 1 year in patients with CD independent of CRP concentrations, with clear separation of adalimumab-treated groups from placebo. The small, nominal differences in absolute remission rates for adalimumab between the CRP-elevated and CRP-normal groups are without clinical significance.