OnabotulinumtoxinA treatment among diverse racial groups: Post hoc analysis of the phase 4 Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) trial
Abstract
OBJECTIVE: Examine treatment responses to and safety of onabotulinumtoxinA for the preventive treatment of chronic migraine (CM) among diverse racial groups.
BACKGROUND: Evidence suggests there are differences in headache treatment patterns, symptom profiles, and burden based on race. However, limited data are available describing the response to preventive migraine treatments among these groups.
METHODS: The Chronic Migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) trial was a single-arm, open-label, multicenter, prospective study (January 23, 2012-November 16, 2015) that enrolled adults of various races with CM to receive onabotulinumtoxinA 155 U every 12 weeks over 108 weeks. These analyses assessed White, Asian (primarily Republic of Korea residents), and Black/African American subgroups based on self-report. Pacific Islander/American Indian/Alaska Native and Hispanic/Latinx subgroups were not analyzed separately because of the small sample sizes and potential overlap with predefined racial categories (e.g., Hispanic/Latinx White) for the latter. Analyses of baseline demographics and clinical characteristics, including headache features, across the subgroups were performed. Change from baseline in the number of monthly headache days (MHDs), including proportions with ≥50% reduction in MHDs, and change from baseline scores on the 6-item Headache Impact Test (HIT-6), Migraine Disability Assessment (MIDAS) absenteeism, presenteeism, and total scores, and…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 716 participants or records.
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