Abstract
BackgroundOnabotulinumtoxinA is effective in treating chronic migraine (CM), but there are limited data assessing how allodynia affects preventive treatment responses. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia.MethodsPatients (n = 715) were treated with onabotulinumtoxinA 155 U every 12 weeks for 9 treatment cycles. The Allodynia Symptom Checklist was used to identify patients with allodynia (scores ≥3). The primary outcome for this subanalysis was reduction in monthly headache days from baseline for weeks 105 to 108 in groups with and without allodynia. Other outcomes included assessments of moderate to severe headache days, disability (using the Migraine Disability Assessment [MIDAS] questionnaire), and health-related quality of life (Migraine-Specific Quality-of-Life Questionnaire [MSQ] v2). Adverse events and their relation to treatment were recorded.ResultsOnabotulinumtoxinA was associated with a significant mean (SD) reduction in headache day frequency at week 108 relative to baseline in patients with (n = 289) and without (n = 426) allodynia (− 10.8 [7.1] and − 12.5 [7.4], respectively; both P < 0.001) that was significantly greater in patients without allodynia (P = 0.044 between-subgroup comparison). Moderate to severe headache days were significantly reduced at week 108 in patients with and without allodynia (− 9.6 [6.9] and − 10.5 [7.2]; both P < 0.001); reduction was similar between groups. MIDAS scores improved significantly at week 108 (− 53.0 [50.3] and − 37.7 [53.0]; both P < 0.001), with a significant between-group difference in favor of those with allodynia (P = 0.005). Similarly, MSQ subscale scores (Role Function Preventive, Role Function Restrictive, Emotional Function) significantly improved at week 108 for patients with and without allodynia: 20.6 (21.9) and 16.9 (20.7), 28.0 (23.3) and 24.7 (22.7), and 27.6 (26.5) and 24.9 (26.1), respectively (all P < 0.001). OnabotulinumtoxinA was well tolerated in patients with and without allodynia.ConclusionResults indicate that onabotulinumtoxinA is associated with reductions from baseline in multiple efficacy outcomes for up to 108 weeks whether or not allodynia is present. The allodynia group showed a smaller treatment response for reduction in headache days, but a similar or greater treatment response for improvement in other measures. No new safety concerns were identified.
Highlights
Chronic migraine (CM) is a debilitating disease occurring in 1.4% to 2.2% of adults globally [1]
Data from the American Migraine Prevalence and Prevention study demonstrated that individuals with allodynia were significantly more likely to have an inadequate response to triptans, nonsteroidal anti-inflammatory drugs, opioids, and barbiturates than those without allodynia [5]
Chronic migraine in people with allodynia is typically considered difficult to manage [5], with acute treatments; little is known about the effect of allodynia on the response to preventive treatment
Summary
Chronic migraine (CM) is a debilitating disease occurring in 1.4% to 2.2% of adults globally [1]. Data from the American Migraine Prevalence and Prevention study demonstrated that individuals with allodynia (defined as a sum score ≥ 3 on the Allodynia Symptom Checklist [ASC]) were significantly more likely to have an inadequate response to triptans, nonsteroidal anti-inflammatory drugs, opioids, and barbiturates than those without allodynia [5]. It remains unclear whether allodynia influences response to preventive treatment. This subanalysis of the 108-week, multicenter, open-label COMPEL Study assessed the efficacy and safety of onabotulinumtoxinA in people with CM with and without allodynia
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