TY - JOUR
T1 - IncobotulinumtoxinA for upper- and lower-limb spasticity in Japanese patients
AU - Kagaya, Hitoshi
AU - Masakado, Yoshihisa
AU - Saitoh, Eiichi
AU - Fujiwara, Toshiyuki
AU - Abo, Masahiro
AU - Izumi, Shin ichi
AU - Nodera, Hiroyuki
AU - Dekundy, Andrzej
AU - Hiersemenzel, Reinhard
AU - Nalaskowski, Christiane Martina
AU - Hanschmann, Angelika
AU - Kaji, Ryuji
N1 - Funding Information:
The authors wish to thank the patients, study investigators, members of the Data Monitoring Committee (Takahiro Mezaki, Takashi Sakamoto, and Takashi Sozu) and EPS International for their contributions to the study. This study was supported by Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany. Medical writing support, under the direction of the authors, was provided by Claire Cairney PhD, CMC Connect, McCann Health Medical Communications, and Kirsteen Munn PhD, on behalf of CMC Connect, in accordance with Good Publication Practice (GPP3) guidelines.
Publisher Copyright:
© 2020, © 2020 Informa UK Limited, trading as Taylor & Francis Group.
PY - 2020/5/3
Y1 - 2020/5/3
N2 - 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.
AB - 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.
KW - Botulinum neurotoxin
KW - incobotulinumtoxinA
KW - lower limb
KW - spasticity
KW - upper limb
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U2 - 10.1080/03007995.2020.1740187
DO - 10.1080/03007995.2020.1740187
M3 - Article
C2 - 32141787
AN - SCOPUS:85083369251
VL - 36
SP - 827
EP - 834
JO - Current Medical Research and Opinion
JF - Current Medical Research and Opinion
SN - 0300-7995
IS - 5
ER -