Abstract
The efficacy and safety of incobotulinumtoxinA ≤400 U was demonstrated in subjects with post-stroke upper-limb spasticity in a randomized, double-blind Phase 3 study with an open-label extension (OLEX; EudraCT number 2005-003951-11, NCT00432666). We report a post-hoc analysis of the duration of the treatment effect. Subjects completing the placebo-controlled main period (single injection cycle with 12–20-week observation) entered the OLEX and received a maximum of five further treatments (maximum duration 69 weeks) with incobotulinumtoxinA ≤400 U at flexible intervals with a minimum duration of 12 weeks, based on clinical need. Intervals between two consecutive incobotulinumtoxinA injections, excluding treatment intervals prior to the end-of-study visit, were evaluated. Of 437 incobotulinumtoxinA treatment intervals, 415 received by 136 subjects were included in the post-hoc analysis. More than half (52.3%; 217/415) of all incobotulinumtoxinA reinjections were administered at Week ≥14, 31.1% (129/415) at Week ≥16, 19.0% (79/415) at Week ≥18, and 11.6% (48/415) at Week ≥20. The duration of effect may vary and can exceed 20 weeks or more, which was observed in at least one injection cycle in 29.4% (40/136) subjects over the course of their treatment. Data show that incobotulinumtoxinA retreatment for upper-limb spasticity may not be required at 12-week intervals and provides evidence for flexible treatment intervals beyond this time frame.
Highlights
Spasticity is a key feature of functional impairment following a stroke, with prevalence in stroke survivors increasing over time and affecting up to 42.6% of stroke survivors in the chronic phase 3–6 months post-stroke [1, 2]
In subjects with cervical dystonia [20] and blepharospasm [21], repeated incobotulinumtoxinA treatment at flexible intervals of 6–20 weeks based on individual treatment requirement resulted in sustained efficacy with no new or unexpected safety concerns or significant differences in the incidence of adverse events at different treatment intervals
We report the results of a post-hoc analysis of the duration of the incobotulinumtoxinA treatment effect in the study detailed above [15, 16], using treatment interval data across up to five complete incobotulinumtoxinA injection cycles for upper-limb spasticity
Summary
Spasticity is a key feature of functional impairment following a stroke, with prevalence in stroke survivors increasing over time and affecting up to 42.6% of stroke survivors in the chronic phase 3–6 months post-stroke [1, 2]. The efficacy and safety of incobotulinumtoxinA in subjects with upper-limb spasticity have been demonstrated in several clinical trials [13,14,15,16,17,18]. In subjects with cervical dystonia [20] and blepharospasm [21], repeated incobotulinumtoxinA treatment at flexible intervals of 6–20 weeks based on individual treatment requirement resulted in sustained efficacy with no new or unexpected safety concerns or significant differences in the incidence of adverse events at different treatment intervals. We report the results of a post-hoc analysis of the duration of the incobotulinumtoxinA treatment effect in the study detailed above [15, 16], using treatment interval data across up to five complete incobotulinumtoxinA injection cycles for upper-limb spasticity
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