Objective: To determine if early post-stroke (within 12 weeks) abobotulinumtoxinA (aboBoNT-A;Dysport®) injections delay appearance or progression of upper limb symptomatic spasticity.

Background: Muscle tone changes in affected limb may be apparent within 2-weeks of stroke. AboBoNT-A is an effective focal intervention for reducing upper limb spasticity (ULS), but is usually administered ≥3 months post-stroke. Limited data exist regarding the effect of early treatment with botulinum toxin A on development of symptomatic post-stroke spasticity.

Methods: ONTIME (NCT02321436) was a 28-week, phase IV, randomized (2:1, aboBoNT-A 500U:placebo), double-blind study in patients with MAS (muscle tone) score ≥2 at baseline. ONTIME assessed impact of aboBoNT-A intramuscular injections administered within 2-12 weeks post-stroke on symptomatic spasticity. Primary endpoint: time between first injection and the visit when composite reinjection criteria were met. Reinjection criteria were a novel composite index comprising a MAS score ≥2 and one of the following signs of symptomatic (disabling) spasticity: pain, involuntary movements, impaired active or passive functions.

Results: 42 patients were randomised (28 aboBoNT-A, 14 placebo; 78.6% male; mean [SD] age, 59.8 [12.3] years) from Malaysia, the Philippines, Singapore and Thailand. At baseline, 76.2% of patients had symptomatic spasticity and the median[range] time since stroke was 5.9[2.3–11.7] weeks. Median[95%CI] time to reaching reinjection criteria was 156.0[86.0; 206.0] days for aboBoNT-A and 32.0[29.0; 114.0] days for placebo (p=0.0176, LogRank). In asymptomatic patients, 1^st quartile time to reaching reinjection criteria was 114.0 days for aboBoNT-A and median time 73.0 days for placebo. In symptomatic patients, median time to reach reinjection criteria was 130.0[30.0; 206.0] days for aboBoNT-A and 32.0[28.0; 85.0] days for placebo.

Conclusions: Median time between first injection and reaching reinjection criteria was statistically significantly longer with aboBoNT-A compared with placebo. Time to reinjection was longer in symptomatic patients compared with asymptomatic patients who received aboBoNT-A. In patients receiving placebo, time to reach reinjection criteria was longer in asymptomatic group than the symptomatic group, although the small sample size in the asymptomatic group must be considered.

Study sponsored by Ipsen

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effect-of-early-abobotulinumtoxina-dysport-use-after-stroke-on-the-time-to-reach-reinjection-criteria-asymptomatic-versus-symptomatic-patients/