IncobotulinumtoxinA for upper- and lower-limb spasticity in Japanese patients

Hitoshi Kagaya, Yoshihisa Masakado, Eiichi Saitoh, Toshiyuki Fujiwara, Masahiro Abo, Shin ichi Izumi, Hiroyuki Nodera, Andrzej Dekundy, Reinhard Hiersemenzel, Christiane Martina Nalaskowski, Angelika Hanschmann, Ryuji Kaji

研究成果: Article査読

抄録

Introduction: The safety and tolerability of incobotulinumtoxinA 400 U for upper- and lower-limb post-stroke spasticity was assessed in a small cohort of Japanese patients during the open-label lead-in tolerability periods (LITP) of two phase 3 studies (CTI-153029 and CTI-153030; Japan Pharmaceutical Information Centre). Methods: Adult patients received a single incobotulinumtoxinA injection session (total dose of 400 U) in the upper (J-PURE) or lower limb (J-PLUS). Adverse events (AEs) were assessed at 1, 4, 8 and 12 weeks post-injection during the 12 week follow-up. Results: The LITP of J-PURE and J-PLUS included 11 patients each. Mild/moderate AEs were reported by 5/11 (45.5%) and 8/11 (72.7%) patients in J-PURE and J-PLUS, respectively. No serious AEs were reported. Non-serious, transient AEs of special interest reported by two patients in J-PURE comprised muscular weakness and eyelid ptosis. No patient discontinued due to AEs. Conclusion: Preliminary results in this small population suggest that incobotulinumtoxinA 400 U is well tolerated for treating upper- or lower-limb post-stroke spasticity in Japanese patients.

本文言語English
ページ(範囲)827-834
ページ数8
ジャーナルCurrent Medical Research and Opinion
36
5
DOI
出版ステータスPublished - 03-05-2020

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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