JianZhong Zhang1, Tsen-Fang Tsai2, Min-Geol Lee3, Min Zheng4, Gang Wang5, HongZhong Jin6, Jun Gu7, RuoYu Li8, QuanZhong Liu9, Jin Chen10, CaiXia Tu11, ChunMei Qi12, Hua Zhu13, William C Ports14, Tim Crook15. 1. Peking University People's Hospital, Department of Dermatology, Beijing, China. Electronic address: rmzjz@126.com. 2. National Taiwan University Hospital, Department of Dermatology, Taipei, Taiwan. Electronic address: tftsai@yahoo.com. 3. Yonsei University College of Medicine, Department of Dermatology, Seoul, Republic of Korea. Electronic address: mglee@yuhs.ac. 4. Second Affiliated Hospital School of Medicine, Zhejiang University, Department of Dermatology, Hangzhou, Zhejiang, China. Electronic address: minz@zju.edu.cn. 5. Xijing Hospital, The Fourth Military Medical University, Department of Dermatology, Xi'an, Shaanxi, China. Electronic address: xjpfwanggang@163.com. 6. Peking Union Medical College Hospital, Department of Dermatology, Beijing, China. Electronic address: jinhongzhong@263.net. 7. Changhai Hospital, The Second Military Medical University, Department of Dermatology, Shanghai, China. Electronic address: gujun79@163.com. 8. Peking University First Hospital, Department of Dermatology, Beijing, China. Electronic address: mycolab@126.com. 9. Tianjin Medical University General Hospital, Department of Dermatology, Tianjin, China. Electronic address: liuquanzhong@medmail.com.cn. 10. Sichuan Provincial People's Hospital, Institute of Dermatology, Chengdu, Sichuan, China. Electronic address: chenjin99114@sina.com. 11. The Second Affiliated Hospital of Dalian Medical University, Department of Dermatology, Dalian, Liaoning, China. Electronic address: tucx2003@163.com. 12. Development China, GPD, Pfizer Investment Co. Ltd., Beijing, China. Electronic address: ChunMei.Qi@Pfizer.com. 13. Pfizer Development China, Shanghai, China. Electronic address: hua.zhu@pfizer.com. 14. Pfizer Inc., Groton, CT, USA. Electronic address: william.c.ports@pfizer.com. 15. Pfizer Ltd., Tadworth, United Kingdom. Electronic address: Tim.Crook@pfizer.com.
Abstract
BACKGROUND:Tofacitinib is an oral Janus kinase inhibitor. OBJECTIVE: This study assessed tofacitinib efficacy and safety vs placebo in Asian patients with moderate to severe chronic plaque psoriasis. METHODS:Patients from China mainland, Taiwan, and Korea were randomized 2:2:1:1 to tofacitinib 5mg (N=88), tofacitinib 10mg (N=90), placebo→5mg (N=44), or placebo→10mg (N=44), twice daily (BID) for 52 weeks. Placebo-treated patients advanced to tofacitinib at Week 16. Co-primary efficacy endpoints: proportions of patients achieving Physician's Global Assessment (PGA) response ('clear' or 'almost clear') and proportion achieving ≥75% reduction from baseline Psoriasis Area and Severity Index (PASI75) at Week 16. RESULTS: At Week 16, more patients achieved PGA and PASI75 responses with tofacitinib 5mg (52.3%; 54.6%) and 10mg (75.6%; 81.1%) BID vs placebo (19.3%; 12.5%; all p<0.0001). Of patients with a Week 16 response, 73.6% and 75.0% maintained PGA response, and 76.8% and 84.9% maintained PASI75 to Week 52 with tofacitinib 5mg and 10mg BID, respectively. Over 52 weeks, 2.2-4.5% of patients across treatment groups experienced serious adverse events, and 1.1-6.8% discontinued due to adverse events. CONCLUSION:Tofacitinib demonstrated efficacy vs placebo at Week 16 in Asian patients with moderate to severe plaque psoriasis; efficacy was maintained through Week 52. No unexpected safety findings were observed. [NCT01815424].
RCT Entities:
BACKGROUND:Tofacitinib is an oral Janus kinase inhibitor. OBJECTIVE: This study assessed tofacitinib efficacy and safety vs placebo in Asian patients with moderate to severe chronic plaque psoriasis. METHODS:Patients from China mainland, Taiwan, and Korea were randomized 2:2:1:1 to tofacitinib 5mg (N=88), tofacitinib 10mg (N=90), placebo→5mg (N=44), or placebo→10mg (N=44), twice daily (BID) for 52 weeks. Placebo-treated patients advanced to tofacitinib at Week 16. Co-primary efficacy endpoints: proportions of patients achieving Physician's Global Assessment (PGA) response ('clear' or 'almost clear') and proportion achieving ≥75% reduction from baseline Psoriasis Area and Severity Index (PASI75) at Week 16. RESULTS: At Week 16, more patients achieved PGA and PASI75 responses with tofacitinib 5mg (52.3%; 54.6%) and 10mg (75.6%; 81.1%) BID vs placebo (19.3%; 12.5%; all p<0.0001). Of patients with a Week 16 response, 73.6% and 75.0% maintained PGA response, and 76.8% and 84.9% maintained PASI75 to Week 52 with tofacitinib 5mg and 10mg BID, respectively. Over 52 weeks, 2.2-4.5% of patients across treatment groups experienced serious adverse events, and 1.1-6.8% discontinued due to adverse events. CONCLUSION:Tofacitinib demonstrated efficacy vs placebo at Week 16 in Asian patients with moderate to severe plaque psoriasis; efficacy was maintained through Week 52. No unexpected safety findings were observed. [NCT01815424].
Authors: El-Bdaoui Haddad; Sonya L Cyr; Kazuhiko Arima; Robert A McDonald; Noah A Levit; Frank O Nestle Journal: Dermatol Ther (Heidelb) Date: 2022-05-21