Adalimumab Therapy Achieves Clinical Remission and Response at Week 26 in Chinese Patients with Crohn's Disease

Abstract

Adalimumab (ADA) is approved for treatment of moderate to severe Crohn's disease (CD) in Western and Japanese countries; however, ADA has not been tested in Chinese patients (pts) with CD. This study evaluated the efficacy and safety of ADA treatment from weeks (wks) 8 to 26 in Chinese pts with moderate to severe CD and elevated high-sensitivity (hs)-CRP. Adult Chinese pts (N = 30) with CD [CD Activity Index (CDAI), 220 to 450; hs-CRP, ≥3 mg/L] were randomized 1:1 and stratified by CD severity (CDAI ≤300 or >300) to receive double-blind (DB) ADA-160/80 mg or -80/40 mg at wks 0/2, followed by ADA 40 mg at wks 4 and 6. At wk 8, all pts received open-label (OL) ADA 40 mg every other week (eow) ..