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Peer-reviewedCC BY 4.0Journal of Rehabilitation Medicine

PROSPECTIVE OBSERVATIONAL STUDY OF STEP-UP DOSE TREATMENT WITH ONABOTULINUMTOXINA IN PATIENTS WITH SPASTICITY

  • Masahiro ABO1
  • Shinichiro KAWAKITA2
  • Naohisa KIKUCHI3
  • Nobuyuki SASAKI4
  • Takashi SHIGEMATSU5
  • Naho OHYANAGI6
  • Yumi YAMAZAKI6
  • Takao MOGI6
  • Yoshiyuki YAMASHITA6
  • Ai HAYASHI6
6 affiliations
  1. 1Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan
  2. 2Department of Rehabilitation Medicine, Keiju Medical Center, Nanao, Japan
  3. 3Department of Rehabilitation Medicine, Chiba Rehabilitation Center, Chiba, Japan
  4. 4Department of Rehabilitation Medicine, St. Marianna University Hospital, Kawasaki, Japan
  5. 5Department of Rehabilitation Medicine, Hamamatsu City Rehabilitation Hospital, Hamamatsu, Japan
  6. 6GlaxoSmithKline K.K., Tokyo, Japan
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Abstract

Objective: To evaluate the safety and effectiveness of “step-up dose” onabotulinumtoxinA (401–600 units per treatment session) in patients with upper and lower limb spasticity.

Design: Multicentre, prospective, observational, single-arm investigation.

Subjects: A convenience sample of 109 patients with upper and lower limb spasticity scheduled to receive their first or second step-up dose onabotulinumtoxinA.

Methods: The study primarily evaluated the safety of step-up dose onabotulinumtoxinA by summarizing adverse events. Effectiveness was evaluated as a secondary objective.

Results: Of the safety population comprising 107 patients, 49 (45.8%) experienced at least 1 adverse event, with coronavirus disease 2019 and nasopharyngitis being the most frequent. Five patients (4.7%) reported adverse events related to onabotulinumtoxinA or injection procedure. These safety findings were generally consistent with those previously reported, while reduction of muscle tone and subsequent clinical benefits were suggested by the Modified Ashworth Scale and patient/physician-reported outcomes.

Conclusion: To the best of our knowledge, this is the first study to prospectively evaluate the safety and effectiveness of onabotulinumtoxinA at doses above 400 units given simultaneously for upper and lower limb spasticity. No new safety concern was identified for this “step-up dose” treatment.

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Cite

BibTeXRIS
BibTeX
@article{masahiro2026prospective,
  title = {{PROSPECTIVE OBSERVATIONAL STUDY OF STEP-UP DOSE TREATMENT WITH ONABOTULINUMTOXINA IN PATIENTS WITH SPASTICITY}},
  author = {Masahiro ABO and Shinichiro KAWAKITA and Naohisa KIKUCHI and Nobuyuki SASAKI and Takashi SHIGEMATSU and Naho OHYANAGI and Yumi YAMAZAKI and Takao MOGI and Yoshiyuki YAMASHITA and Ai HAYASHI},
  journal = {Journal of Rehabilitation Medicine},
  year = {2026},
  month = oct,
  doi = {10.2340/jrm.v58.45826},
  url = {https://doi.org/10.2340/jrm.v58.45826},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - PROSPECTIVE OBSERVATIONAL STUDY OF STEP-UP DOSE TREATMENT WITH ONABOTULINUMTOXINA IN PATIENTS WITH SPASTICITY
AU  - Masahiro ABO
AU  - Shinichiro KAWAKITA
AU  - Naohisa KIKUCHI
AU  - Nobuyuki SASAKI
AU  - Takashi SHIGEMATSU
AU  - Naho OHYANAGI
AU  - Yumi YAMAZAKI
AU  - Takao MOGI
AU  - Yoshiyuki YAMASHITA
AU  - Ai HAYASHI
PY  - 2026
DA  - 2026/10/28
JO  - Journal of Rehabilitation Medicine
DO  - 10.2340/jrm.v58.45826
UR  - https://doi.org/10.2340/jrm.v58.45826
AB  - Objective: To evaluate the safety and effectiveness of “step-up dose” onabotulinumtoxinA (401–600 units per treatment session) in patients with upper and lower limb spasticity.  Design: Multicentre, prospective, observational, single-arm investigation.  Subjects: A convenience sample of 109 patients with upper and lower limb spasticity scheduled to receive their first or second step-up dose onabotulinumtoxinA.  Methods: The study primarily evaluated the safety of step-up dose onabotulinumtoxinA by summarizing adverse events. Effectiveness was evaluated as a secondary objective.  Results: Of the safety population comprising 107 patients, 49 (45.8%) experienced at least 1 adverse event, with coronavirus disease 2019 and nasopharyngitis being the most frequent. Five patients (4.7%) reported adverse events related to onabotulinumtoxinA or injection procedure. These safety findings were generally consistent with those previously reported, while reduction of muscle tone and subsequent clinical benefits were suggested by the Modified Ashworth Scale and patient/physician-reported outcomes.  Conclusion: To the best of our knowledge, this is the first study to prospectively evaluate the safety and effectiveness of onabotulinumtoxinA at doses above 400 units given simultaneously for upper and lower limb spasticity. No new safety concern was identified for this “step-up dose” treatment.
SN  - 1650-1977
SN  - 1651-2081
ER  -