PMID- 27504914 OWN - NLM STAT- MEDLINE DCOM- 20170501 LR - 20181113 IS - 1468-3083 (Electronic) IS - 0926-9959 (Print) IS - 0926-9959 (Linking) VI - 31 IP - 1 DP - 2017 Jan TI - 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. PG - 89-95 LID - 10.1111/jdv.13746 [doi] AB - BACKGROUND: This phase 3 trial is the first to evaluate the efficacy and safety of treatment with the systemic TNF-alpha 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). CONCLUSION: 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. CI - (c) 2016 The Authors. Journal of European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venerology. FAU - Cai, L AU - Cai L AD - Peking University People's Hospital, Beijing, China. FAU - Gu, J AU - Gu J AD - Shanghai Changhai Hospital, Shanghai, China. FAU - Zheng, J AU - Zheng J AD - Ruijin Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Zheng, M AU - Zheng M AD - Second Affiliated Hospital Zhejiang University College of Medicine, Hangzhou, China. FAU - Wang, G AU - Wang G AD - The first Affiliated Hospital of Fourth Military Medical University, PLA (Xijing Hospital), Xi'an, China. FAU - Xi, L-Y AU - Xi LY AD - Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China. FAU - Hao, F AU - Hao F AD - The First Affiliated Hospital of Third Military Medical University, PLA (Southwest Hospital), Chongqing, China. FAU - Liu, X-M AU - Liu XM AD - First Affiliated Hospital of Dalian Medical University, Dalian, China. FAU - Sun, Q-N AU - Sun QN AD - Peking Union Medical College Hospital, Beijing, China. FAU - Wang, Y AU - Wang Y AD - Peking University First Hospital, Beijing, China. FAU - Lai, W AU - Lai W AD - The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. FAU - Fang, H AU - Fang H AD - The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, China. FAU - Tu, Y-T AU - Tu YT AD - Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China. FAU - Sun, Q AU - Sun Q AD - Qilu Hospital of Shandong University, Jinan, China. FAU - Chen, J AU - Chen J AD - Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China. FAU - Gao, X-H AU - Gao XH AD - The First Hospital of China Medical University, Shenyang, China. FAU - Gu, Y AU - Gu Y AD - AbbVie Inc., North Chicago, IL, USA. FAU - Teixeira, H D AU - Teixeira HD AD - AbbVie Inc., North Chicago, IL, USA. FAU - Zhang, J-Z AU - Zhang JZ AD - Peking University People's Hospital, Beijing, China. FAU - Okun, M M AU - Okun MM AD - Fort HealthCare, Fort Atkinson, WI, USA. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20160809 PL - England TA - J Eur Acad Dermatol Venereol JT - Journal of the European Academy of Dermatology and Venereology : JEADV JID - 9216037 RN - 0 (Placebos) RN - FYS6T7F842 (Adalimumab) SB - IM MH - Adalimumab/*therapeutic use MH - Adult MH - China MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Placebos MH - Psoriasis/*drug therapy PMC - PMC5215651 EDAT- 2016/08/10 06:00 MHDA- 2017/05/02 06:00 PMCR- 2017/01/05 CRDT- 2016/08/10 06:00 PHST- 2016/01/05 00:00 [received] PHST- 2016/03/30 00:00 [accepted] PHST- 2016/08/10 06:00 [pubmed] PHST- 2017/05/02 06:00 [medline] PHST- 2016/08/10 06:00 [entrez] PHST- 2017/01/05 00:00 [pmc-release] AID - JDV13746 [pii] AID - 10.1111/jdv.13746 [doi] PST - ppublish SO - J Eur Acad Dermatol Venereol. 2017 Jan;31(1):89-95. doi: 10.1111/jdv.13746. Epub 2016 Aug 9.