Separate analyses for each DAS domain were performed using pooled data from patients with each limb position abnormality, dressing-, and hygiene-related disability at baseline (DAS score ≥1 for that domain). Patients with more than one domain score ≥ 1 could be included in multiple analyses.
DAS response rates over time for all injection cycles relative to baseline were recorded at injection visit 1 (baseline), at each subsequent injection visit if applicable, and at control visits 4 weeks (±3 days) after each injection. Response rates for incobotulinumtoxinA versus placebo were compared 4 weeks after the first injection using Wald tests (95% CI) and evaluated 4 weeks after each injection visit of the subsequent three cycles for incobotulinumtoxinA without placebo control. For the placebo-controlled studies, after the placebo injection cycle (first cycle only), data from patients who subsequently received incobotulinumtoxinA in an open-label extension phase were included with data from the original incobotulinumtoxinA groups (data assigned to first, second, and third incobotulinumtoxinA doses).
Data for limb position abnormality, dressing-, and hygiene-related disability at week 4 following incobotulinumtoxinA injection were analyzed in terms of the proportion of incobotulinumtoxinA- and placebo-treated patients who responded to treatment and the likelihood of response to incobotulinumtoxinA versus placebo (logistic regression analysis, presented as an OR analyzed using the chi-square test and 95% Wald CI). Furthermore, several subgroup analyses were performed using data from the first injection cycle. The difference in overall response rates to incobotulinumtoxinA versus placebo according to baseline severity of the respective DAS domain (mild, moderate, severe) was assessed, as well as the difference in overall response rates to incobotulinumtoxinA versus placebo according to time since stroke (0–2 years, 3–5 years, 6–10 years, >10 years). The proportion of incobotulinumtoxinA- and placebo-treated patients who responded to treatment according to PTT (any of the four DAS domains) was also evaluated after all injection cycles.
Analyses were based on observed cases; there was no strategy for missing postbaseline data in participants with a domain DAS score ≥1 at baseline, as few data were missing (limb position abnormality, 2.5% (n = 23), dressing disability, 2.4% (n = 22), hygiene-related disability, 2.4% (n = 21)). Analyses were performed using Statistical Analysis Software (SAS) 9.4 (SAS Institute Inc., Cary, NC, USA). Logistic regression was used to calculate ORs and associated p-values. For response differences, Wald tests and 95% CIs were computed.
DAS response rates over time for all injection cycles relative to baseline were recorded at injection visit 1 (baseline), at each subsequent injection visit if applicable, and at control visits 4 weeks (±3 days) after each injection. Response rates for incobotulinumtoxinA versus placebo were compared 4 weeks after the first injection using Wald tests (95% CI) and evaluated 4 weeks after each injection visit of the subsequent three cycles for incobotulinumtoxinA without placebo control. For the placebo-controlled studies, after the placebo injection cycle (first cycle only), data from patients who subsequently received incobotulinumtoxinA in an open-label extension phase were included with data from the original incobotulinumtoxinA groups (data assigned to first, second, and third incobotulinumtoxinA doses).
Data for limb position abnormality, dressing-, and hygiene-related disability at week 4 following incobotulinumtoxinA injection were analyzed in terms of the proportion of incobotulinumtoxinA- and placebo-treated patients who responded to treatment and the likelihood of response to incobotulinumtoxinA versus placebo (logistic regression analysis, presented as an OR analyzed using the chi-square test and 95% Wald CI). Furthermore, several subgroup analyses were performed using data from the first injection cycle. The difference in overall response rates to incobotulinumtoxinA versus placebo according to baseline severity of the respective DAS domain (mild, moderate, severe) was assessed, as well as the difference in overall response rates to incobotulinumtoxinA versus placebo according to time since stroke (0–2 years, 3–5 years, 6–10 years, >10 years). The proportion of incobotulinumtoxinA- and placebo-treated patients who responded to treatment according to PTT (any of the four DAS domains) was also evaluated after all injection cycles.
Analyses were based on observed cases; there was no strategy for missing postbaseline data in participants with a domain DAS score ≥1 at baseline, as few data were missing (limb position abnormality, 2.5% (n = 23), dressing disability, 2.4% (n = 22), hygiene-related disability, 2.4% (n = 21)). Analyses were performed using Statistical Analysis Software (SAS) 9.4 (SAS Institute Inc., Cary, NC, USA). Logistic regression was used to calculate ORs and associated p-values. For response differences, Wald tests and 95% CIs were computed.
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