Dataset Information

Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

ABSTRACT: Background:This study evaluated the safety and efficacy of onabotulinumtoxinA for the treatment of crow's feet lines (CFL) in Chinese subjects. Methods:This 5-month, double-blind, randomized, parallel-group, placebo-controlled phase 3 study was conducted in China. Subjects with moderate-to-severe CFL at maximum smile received a single treatment of onabotulinumtoxinA 24 U (total; n = 316) or placebo (n = 101) on day 1. The primary efficacy measure was the proportion of investigator-assessed responders (achieved CFL severity of none or mild at maximum smile using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30). Additional endpoints included other response definitions (achieving at least 1-grade improvement at maximum smile and at rest using the Facial Wrinkle Scale with Asian Photonumeric Guide at day 30), duration of effect, subject-reported outcomes, and safety. Results:All efficacy endpoints were met. At day 30, the proportion of subjects achieving none or mild severity at maximum smile was significantly greater (P < 0.001) in the onabotulinumtoxinA group (63.9%) versus the placebo group (5.0%). The proportion of subjects assessing the change in CFL appearance as much improved/very much improved was also significantly greater with onabotulinumtoxinA than placebo (P < 0.001). Subjects' self-assessed outcomes were similar to investigator-assessed results. Median duration of effect with onabotulinumtoxinA was ?5 months using all responder definitions. A low occurrence of treatment-related adverse events was reported, with no new safety findings. Conclusions:OnabotulinumtoxinA 24 U was effective and well tolerated for the treatment of CFL in Chinese subjects, with responses maintained over 5 months.

SUBMITTER: Wu Y

PROVIDER: S-EPMC6382241 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

Wu Yan Y Wang Gang G Li Chengxin C Mao Cheri C Lei Xiaofang X Lee Elisabeth E

Plastic and reconstructive surgery. Global open 20190122 1

<h4>Background</h4>This study evaluated the safety and efficacy of onabotulinumtoxinA for the treatment of crow's feet lines (CFL) in Chinese subjects.<h4>Methods</h4>This 5-month, double-blind, randomized, parallel-group, placebo-controlled phase 3 study was conducted in China. Subjects with moderate-to-severe CFL at maximum smile received a single treatment of onabotulinumtoxinA 24 U (total; n = 316) or placebo (n = 101) on day 1. The primary efficacy measure was the proportion of investigator ...[more]

PMID: 30859038

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Project description:ObjectiveChronic migraine (CM) is a prevalent and disabling neurological disorder. Phase III REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program assessed efficacy and safety of onabotulinumtoxinA (BOTOX(®)) for prophylaxis of headaches in adults with CM. This secondary analysis assessed patients who received all five treatment cycles and completed the study.Materials and methodsPREEMPT (two phase III studies: 24-week double-blind, placebo-controlled [DBPC], parallel-group phase, followed by 32-week open-label [OL] phase) evaluated the efficacy and safety of onabotulinumtoxinA in CM (≥15 days/month with headache lasting ≥4 h a day). Patients were randomized (1:1) to onabotulinumtoxinA or placebo every 12 weeks for two cycles, followed by onabotulinumtoxinA for three cycles. Multiple headache symptom measures were evaluated. Results for the completer (five cycles) subgroup of patients are reported.ResultsOf 1384 total PREEMPT patients, 1005 received all five treatment cycles (513 received onabotulinumtoxinA only [onabotulinumtoxinA/onabotulinumtoxinA (O/O)] and 492 received two cycles of placebo then three cycles of onabotulinumtoxinA [placebo/onabotulinumtoxinA (P/O)]). Demographics were similar between treatment groups. At Week 56, after all patients were treated with onabotulinumtoxinA, there continued to be significant between-group differences favoring the O/O vs P/O group for the following headache symptom measures: LS mean change from baseline in frequencies of headache days (-12.0 O/O, -11.1 P/O; P = 0.035), migraine days (-11.6 O/O, -10.7 P/O; P = 0.038), and moderate/severe headache days (-11.0 O/O, -10.1 P/O; P = 0.042). For other measures (cumulative hours of headache on headache days, frequency of headache episodes, and percentage with severe Headache Impact Test (HIT)-6 score, and total HIT-6 and Migraine-Specific Quality of Life Questionnaire scores), there were also large mean improvements from baseline. The percent of patients with a ≥50% reduction from baseline in frequency of headache days was significantly greater for the onabotulinumtoxinA-only group at Week 56 (69.6% O/O, 62.8% P/O; P = 0.023). The treatment-related adverse event rate was 28.5% for onabotulinumtoxinA vs 12.4% for placebo in the DBPC phase and 34.8% for patients treated with onabotulinumtoxinA for all five cycles throughout the 56-week trials.ConclusionsThis subgroup analysis demonstrated improvements with onabotulinumtoxinA treatment (five cycles) vs placebo (two cycles)/onabotulinumtoxinA (three cycles) for multiple headache symptom measures and suggests that at Week 56, patients treated earlier with onabotulinumtoxinA had better outcomes. These findings demonstrate the continued need and cumulative benefit over time with continued prophylaxis, an important and clinically pragmatic observation for clinicians and patients.

Dataset Information

Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

Publications

Safety and Efficacy of OnabotulinumtoxinA for Treatment of Crow's Feet Lines in Chinese Subjects.

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