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

Abstract

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.

Keywords:

• Botulinum neurotoxin
• incobotulinumtoxinA
• lower limb
• spasticity
• upper limb

Notes

Transparency

Declaration of funding

This study was funded by Merz Pharmaceuticals GmbH.

Declaration of financial/other relationships

No potential conflict of interest was reported by H.K., Y.M., E.S., T.F., M.A., S.I. or H.N. A.D., C.M.N., A.H. and R.H. have disclosed that they are employees of Merz Pharmaceuticals GmbH. R.K. has disclosed that he has received consultancy fees from Merz Pharmaceuticals GmbH. CMRO peer reviewers on this manuscript have received an honorarium from CMRO for their review work but have no relevant financial or other relationships to disclose.

Author contributions

H.K., Y.M., E.S., T.F., M.A., S.I., H.N. and R.K. were involved in the acquisition and interpretation of study data and in the critical revision of the manuscript for important intellectual content. A.D., R.H., C.M.N. and A.H. were involved in the study concept and design, and the acquisition, analysis and interpretation of study data. They were also involved in the critical revision of the manuscript for important intellectual content.

Acknowledgements

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.

Notes

i Xeomin is a registered trade name of Merz Pharmaceuticals GmbH.