The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study

Jian Zhong Zhang, Tsen Fang Tsai, Min Geol Lee, Min Zheng, Gang Wang, Hong Zhong Jin, Jun Gu, Ruo Yu Li, Quan Zhong Liu, Jin Chen, Cai Xia Tu, Chun Mei Qi, Hua Zhu, William C. Ports, Tim Crook

Research output: Contribution to journalArticle

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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 5 mg (N = 88), tofacitinib 10 mg (N = 90), placebo → 5 mg (N = 44), or placebo → 10 mg (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 5 mg (52.3%; 54.6%) and 10 mg (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 5 mg and 10 mg 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]

Original languageEnglish
Pages (from-to)36-45
Number of pages10
JournalJournal of Dermatological Science
Volume88
Issue number1
DOIs
Publication statusPublished - 2017 Oct

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Psoriasis
Placebos
Safety
Physicians
Patient treatment
Janus Kinases
tofacitinib
Korea
Taiwan
China

All Science Journal Classification (ASJC) codes

  • Biochemistry
  • Molecular Biology
  • Dermatology

Cite this

Zhang, Jian Zhong ; Tsai, Tsen Fang ; Lee, Min Geol ; Zheng, Min ; Wang, Gang ; Jin, Hong Zhong ; Gu, Jun ; Li, Ruo Yu ; Liu, Quan Zhong ; Chen, Jin ; Tu, Cai Xia ; Qi, Chun Mei ; Zhu, Hua ; Ports, William C. ; Crook, Tim. / The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis : A Phase 3, randomized, double-blind, placebo-controlled study. In: Journal of Dermatological Science. 2017 ; Vol. 88, No. 1. pp. 36-45.
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title = "The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis: A Phase 3, randomized, double-blind, placebo-controlled study",
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 5 mg (N = 88), tofacitinib 10 mg (N = 90), placebo → 5 mg (N = 44), or placebo → 10 mg (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 5 mg (52.3{\%}; 54.6{\%}) and 10 mg (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 5 mg and 10 mg 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]",
author = "Zhang, {Jian Zhong} and Tsai, {Tsen Fang} and Lee, {Min Geol} and Min Zheng and Gang Wang and Jin, {Hong Zhong} and Jun Gu and Li, {Ruo Yu} and Liu, {Quan Zhong} and Jin Chen and Tu, {Cai Xia} and Qi, {Chun Mei} and Hua Zhu and Ports, {William C.} and Tim Crook",
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The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis : A Phase 3, randomized, double-blind, placebo-controlled study. / Zhang, Jian Zhong; Tsai, Tsen Fang; Lee, Min Geol; Zheng, Min; Wang, Gang; Jin, Hong Zhong; Gu, Jun; Li, Ruo Yu; Liu, Quan Zhong; Chen, Jin; Tu, Cai Xia; Qi, Chun Mei; Zhu, Hua; Ports, William C.; Crook, Tim.

In: Journal of Dermatological Science, Vol. 88, No. 1, 10.2017, p. 36-45.

Research output: Contribution to journalArticle

TY - JOUR

T1 - The efficacy and safety of tofacitinib in Asian patients with moderate to severe chronic plaque psoriasis

T2 - A Phase 3, randomized, double-blind, placebo-controlled study

AU - Zhang, Jian Zhong

AU - Tsai, Tsen Fang

AU - Lee, Min Geol

AU - Zheng, Min

AU - Wang, Gang

AU - Jin, Hong Zhong

AU - Gu, Jun

AU - Li, Ruo Yu

AU - Liu, Quan Zhong

AU - Chen, Jin

AU - Tu, Cai Xia

AU - Qi, Chun Mei

AU - Zhu, Hua

AU - Ports, William C.

AU - Crook, Tim

PY - 2017/10

Y1 - 2017/10

N2 - 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 5 mg (N = 88), tofacitinib 10 mg (N = 90), placebo → 5 mg (N = 44), or placebo → 10 mg (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 5 mg (52.3%; 54.6%) and 10 mg (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 5 mg and 10 mg 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]

AB - 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 5 mg (N = 88), tofacitinib 10 mg (N = 90), placebo → 5 mg (N = 44), or placebo → 10 mg (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 5 mg (52.3%; 54.6%) and 10 mg (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 5 mg and 10 mg 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]

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