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https://hdl.handle.net/20.500.14094/90004762
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2024-04-25
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90004762 (fulltext)
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メタデータID
90004762
アクセス権
open access
出版タイプ
Version of Record
タイトル
Tofacitinib for the treatment of moderate to severe chronic plaque psoriasis in Japanese patients: Subgroup analyses from a randomized, placebo-controlled phase 3 trial
著者
Abe, Masatoshi ; Nishigori, Chikako ; Torii, Hideshi ; Ihn, Hironobu ; Ito, Kei ; Nagaoka, Makoto ; Isogawa, Naoki ; Kawaguchi, Isao ; Tomochika, Yukiko ; Kobayashi, Mihoko ; Tallman, Anna M. ; Papp, Kim A.
著者名
Abe, Masatoshi
著者ID
A0395
研究者ID
1000050198454
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=e6f42019bd45236f520e17560c007669
著者名
Nishigori, Chikako
錦織, 千佳子
ニシゴリ, チカコ
所属機関名
医学研究科
著者名
Torii, Hideshi
著者名
Ihn, Hironobu
著者名
Ito, Kei
著者名
Nagaoka, Makoto
著者名
Isogawa, Naoki
著者名
Kawaguchi, Isao
著者名
Tomochika, Yukiko
著者名
Kobayashi, Mihoko
著者名
Tallman, Anna M.
著者名
Papp, Kim A.
収録物名
The Journal of Dermatology
巻(号)
44(11)
ページ
1228-1237
出版者
Wiley
刊行日
2017-11
公開日
2018-04-06
抄録
Tofacitinib is an oral Janus kinase inhibitor. These post-hoc analyses assessed tofacitinib efficacy and safety in Japanese patients with psoriasis enrolled in a 52-week global phase 3 study. Patients received tofacitinib 5 mg, tofacitinib 10 mg or placebo twice daily (b.i.d.); placebo-treated patients advanced to tofacitinib at week 16. Primary efficacy end-points were the proportions of patients with 75% or more reduction from baseline Psoriasis Area and Severity Index (PASI-75) and Physician's Global Assessment (PGA) of "clear" or "almost clear" (PGA response) at week 16. Other end-points included: Itch Severity Item (ISI), Dermatology Life Quality Index (DLQI) score and Nail Psoriasis Severity Index (NAPSI). Adverse events (AEs) were recorded throughout the study. Overall, 58 Japanese patients were included in this analysis (tofacitinib 5 mg b.i.d., n = 22; 10 mg b.i.d., n = 24; placebo, n = 12); 29 completed the study. At week 16, significantly more patients receiving tofacitinib 5 and 10 mg b.i.d. versus placebo achieved PASI-75 (50% and 75% vs 0%, P < 0.01) and PGA response (59% and 75% vs 0%, P < 0.001). Substantial improvements in ISI, DLQI and NAPSI score were observed with both tofacitinib doses. Over 52 weeks, similar rates of AEs were reported across treatment groups; one serious AE occurred with tofacitinib 10 mg b.i.d. Herpes zoster occurred in three patients receiving tofacitinib 10 mg b.i.d. No deaths, serious infections, malignancies or gastrointestinal perforations were reported. Results were generally consistent with global analysis, suggesting sustained efficacy and a manageable safety profile, with increased herpes zoster incidence, of tofacitinib in Japanese patients with psoriasis.
キーワード
Janus kinase inhibitor
Japanese
oral medicine
plaque psoriasis
tofacitinib
カテゴリ
医学研究科
学術雑誌論文
権利
© 2017 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
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資源タイプ
journal article
言語
English (英語)
ISSN
0385-2407
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eISSN
1346-8138
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関連情報
DOI
https://doi.org/10.1111/1346-8138.13956
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