title: Efficacy and safety of adalimumab in Chinese patients with moderate-to-severe plaque psoriasis: results from a phase 3, randomized, placebo-controlled, double-blind study.
abstract: BACKGROUND
  This phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF-α inhibitor, adalimumab, for Chinese patients with moderate-to-severe plaque psoriasis.
  
  
  METHODS
  In the 12-week, double-blind, placebo-controlled Period A, patients were randomized 4 : 1 to receive adalimumab 40 mg every-other-week (following a single 80 mg dose), or placebo every-other-week. In the subsequent 12-week, open-label, Period B, all patients received adalimumab 40 mg every-other-week starting at week 13, following a single, blinded dose at week 12 of adalimumab 80 mg or matching placebo (for patients receiving placebo or adalimumab in Period A respectively). In Period A, efficacy was analysed for all randomized patients and safety for all patients receiving ≥1 dose of the study drug.
  
  
  RESULTS
  For the 425 patients in this study (87 placebo; 338 adalimumab), a higher percentage randomized to adalimumab achieved the primary endpoint of ≥75% improvement from baseline in PASI score (PASI 75) at week 12: placebo 11.5% (10/87); adalimumab 77.8% (263/338; P < 0.001). Physician's Global Assessment of clear to minimal was achieved at week 12 by 14.9% placebo (13/87) and 80.5% adalimumab (272/338; P < 0.001). For patients who received adalimumab at any time during the study (All-adalimumab Population), treatment-emergent adverse events (AEs) were reported by 63.4%; the most common was upper respiratory infection (16.1%). Serious AEs were reported by 3.5% of the All-adalimumab Population, and serious infectious AEs by 1.2%, which include lung infection, pneumonia and tuberculosis [2 (0.5%) patients each]. There was one death (chronic heart failure).
  
  
  CONCLUSIONS
  In these Chinese patients with moderate-to-severe psoriasis, a significantly greater percentage treated with adalimumab compared with placebo achieved efficacy endpoints at week 12 and efficacy was sustained to week 24. Safety results were consistent with the known adalimumab safety profile; no new safety signals were identified in the 24 weeks of treatment.
authors: Peking University People's Hospital, Beijing, China.
authors: L
authors: L
authors: Cai
authors: Shanghai Changhai Hospital, Shanghai, China.
authors: J
authors: J
authors: Gu
authors: Ruijin Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China.
authors: J
authors: J
authors: Zheng
authors: Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China.
authors: M
authors: M
authors: Zheng
authors: The first Affiliated Hospital of Fourth Military Medical University, PLA (Xijing Hospital), Xi'an, China.
authors: G
authors: G
authors: Wang
authors: Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
authors: L-Y
authors: LY
authors: Xi
authors: The First Affiliated Hospital of Third Military Medical University, PLA (Southwest Hospital), Chongqing, China.
authors: F
authors: F
authors: Hao
authors: First Affiliated Hospital of Dalian Medical University, Dalian, China.
authors: X-M
authors: XM
authors: Liu
authors: Peking Union Medical College Hospital, Beijing, China.
authors: Q-N
authors: QN
authors: Sun
authors: Peking University First Hospital, Beijing, China.
authors: Y
authors: Y
authors: Wang
authors: The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
authors: W
authors: W
authors: Lai
authors: The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China.
authors: H
authors: H
authors: Fang
authors: Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.
authors: Y-T
authors: YT
authors: Tu
authors: Qilu Hospital of Shandong University, Jinan, China.
authors: Q
authors: Q
authors: Sun
authors: Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.
authors: J
authors: J
authors: Chen
authors: The First Hospital of China Medical University, Shenyang, China.
authors: X-H
authors: XH
authors: Gao
authors: AbbVie Inc., North Chicago, IL, USA.
authors: Y
authors: Y
authors: Gu
authors: AbbVie Inc., North Chicago, IL, USA.
authors: H D
authors: HD
authors: Teixeira
authors: Peking University People's Hospital, Beijing, China.
authors: J-Z
authors: JZ
authors: Zhang
authors: Fort HealthCare, Fort Atkinson, WI, USA.
authors: M M
authors: MM
authors: Okun
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use*; D000328:Adult; D002681:China; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011565:Psoriasis / Q000188:drug therapy*
chemical_list: D010919:Placebos; D000068879:Adalimumab