Evidence map›Paper›PMID 41527032›Full record

ArticleBMC neurology2026

Long-term safety and treatment discontinuation patterns of OnabotulinumtoxinA for post-stroke spasticity: a retrospective study.

Ken Azuma, Michiyuki Kawakami, Naoko Watabe, Takayuki Kamimoto, Osamu Oshima, Yuka Yamada, Ayako Wada, Aiko Ishikawa, Tetsuya Tsuji

Abstract read
In one paragraph

Article in BMC neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Ken AzumaDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Michiyuki KawakamiDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan. michiyukikawakami@keio.jp.
Naoko WatabeDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Takayuki KamimotoDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Osamu OshimaDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Yuka YamadaDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Ayako WadaDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Aiko IshikawaDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Tetsuya TsujiDepartment of Rehabilitation Medicine, Keio University School of Medicine, 35, Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.

Funding

Japan Society for the Promotion of Science 23H00458
6 · The paper itself

Abstract

backgroundPost-stroke spasticity affects a significant proportion of stroke survivors and impairs quality of life. Repeated intramuscular injections of OnabotulinumtoxinA are widely used for spasticity management; however, long-term real-world outcomes remain underreported. This study aimed to evaluate the long-term safety and treatment continuation patterns, and to identify predictors of treatment discontinuation associated with repeated onabotulinumtoxinA treatment.

methodsThis retrospective, single-center study included 224 post-stroke patients treated with OnabotulinumtoxinA between 2012 and 2023. Inclusion criteria were a diagnosis of post-stroke spasticity, initiation of treatment before 2021, and at least three years of follow-up. Outcomes assessed included treatment continuation rates, reasons for discontinuation, dose trends, and predictors of treatment discontinuation. Logistic regression and repeated measures ANOVA were used for statistical analyses.

resultsOf the 224 patients, 94 (42%) continued treatment as of December 2023. Reasons for discontinuation included improvement and completion (n = 59, 45.4%), unknown reason (n = 39, 30.0%), Change of doctor or relocation (n = 13, 10.0%), insufficient efficacy (n = 13, 10.0%), switch to other treatment (n = 4, 3.1%), and adverse events (n = 2, 1.5%). Long-term treatment was associated with progressive dose escalation (p < 0.05).Logistic regression analysis showed that cerebral infarction was significantly associated with treatment completion due to improvement(p = 0.004), while a lower initial dose demonstrated a non-significant trend toward treatment completion (p = 0.051).

conclusionsRepeated onabotulinumtoxinA injections were not associated with unexpected safety concerns over long-term follow-up. Approximately 25% of patients discontinued treatment during the observation period, including cases documented as treatment completion due to clinical improvement. Stroke type was associated with treatment discontinuation patterns, supporting the importance of individualized long-term treatment planning.

Indexed as

Botulinum Toxins, Type AMuscle SpasticityNeuromuscular AgentsStrokeAgedAged, 80 and overFemaleHumansInjections, IntramuscularMaleMiddle AgedRetrospective StudiesTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsonabotulinum toxin ALong-term treatmentOnabotulinumtoxinASafetySpasticityStrokeTreatment discontinuation

Identifiers

PMID41527032
PMCPMC12888325

What Socratic holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.