Dataset Information

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

ABSTRACT:

Background

OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at rest; however, less is known regarding the effect of repeat treatment on more severe lines at rest.

Objective

To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest.

Methods

Subjects 18 to 75 years old with at least mild glabellar lines at rest, as assessed by the validated Facial Wrinkle Scale (FWS) with photonumeric guide (score ? 1), received 3 treatments of 20 U onabotulinumtoxinA 4 months apart (N = 225). "Response" was defined as elimination of glabellar lines at rest (FWS score = 0) at any time point (Days 7, 30, 60, 90, and 120). Effect of treatment cycle on response was analyzed using repeated measures logistic regressions (p < .05).

Results

Most subjects were female (85%) and white (88%) (age range: 35-54 years). The likelihood of significant response was as follows: for all subjects combined (odds ratio [OR]: 1.31), for subjects with mild resting lines at baseline (OR: 1.49), and for older women (?55 years) with mild resting lines at baseline (OR: 2.22). Of all subjects, 76% responded after 1 treatment, and 45% responded in all 3 cycles.

Conclusion

Subjects repeatedly treated with onabotulinumtoxinA showed progressive improvement in glabellar lines at rest.

SUBMITTER: Carruthers A

PROVIDER: S-EPMC5414762 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

Carruthers Alastair A Carruthers Jean J Fagien Steven S Lei Xiaofang X Kolodziejczyk Julia J Brin Mitchell F MF

Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.] 20160901 9

<h4>Background</h4>OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at rest; however, less is known regarding the effect of repeat treatment on more severe lines at rest.<h4>Objective</h4>To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest.<h4>Methods</h4>Subjects 18 to 75 years old with at least mild glabellar lines at rest, as assessed by the validated Facial Wrinkle Scale (FWS) with photonumeric guide (score ≥ ...[more]

PMID: 27427996

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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

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

Background

Objective

Methods

Results

Conclusion

Publications

Repeated OnabotulinumtoxinA Treatment of Glabellar Lines at Rest Over Three Treatment Cycles.

Similar Datasets

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