Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Abstract

Introduction/Objective: Chronic migraine (CM) is associated with impaired health-related quality of life and substantial socioeconomic burden, but many people with CM are underdiagnosed and do not receive appropriate preventive treatment. OnabotulinumtoxinA and topiramate have demonstrated efficacy (treatment benefit under ideal conditions) for the prevention of headaches in people with CM in clinical trials, but real-world studies suggest markedly different clinical effectiveness (treatment benefit based on a blend of efficacy and tolerability). This study sought to evaluate patient-reported outcomes (PROs) of onabotulinumtoxinA versus topiramate immediate release for people with CM. Methods: FORWARD was a prospective, multicenter, randomized, parallel-group, open-label, phase 4 study comparing onabotulinumtoxinA 155 U every 12 weeks with topiramate 50 to 100 mg/day for ≤36 weeks in people with CM. PROs measured included the Headache Impact Test (HIT-6), 9-item Patient Health Questionnaire Quick Depression Assessment (PHQ-9), Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP), and Functional Impact of Migraine Questionnaire (FIMQ). Results: A total of 282 patients were randomized and treated with onabotulinumtoxinA (n = 140) or topiramate (n = 142). From baseline to week 30, mean HIT-6 test scores improved significantly in patients taking onabotulinumtoxinA compared with topiramate ( P < .001). Improvements in depression over time were observed via larger changes in PHQ-9 scores with onabotulinumtoxinA than topiramate ( P < .001). Work productivity assessed via WPAI:SHP scores revealed significant improvements with onabotulinumtoxinA versus topiramate in Work Productivity Loss ( P = .024) and Activity Impairment ( P < .001) domains. Results from the FIMQ also revealed a larger reduction from baseline with onabotulinumtoxinA vs topiramate ( P < .0001). Conclusion: OnabotulinumtoxinA treatment had more favorable real-world effectiveness than topiramate on depression, headache impact, functioning and daily living, activity, and work productivity. The overall study results suggest that the beneficial effects on a range of PROs are the result of improved effectiveness when onabotulinumtoxinA is used as preventive treatment for CM. Trial Registration: ClinicalTrials.gov: NCT02191579; https://clinicaltrials.gov/ct2/show/NCT02191579

Long‐term adherence, safety, and efficacy of repeated onabotulinumtoxinA over five years in chronic migraine prophylaxis

“…Furthermore, BoNTA demonstrated its efficacy in about 70% of treated patients after three courses of BoNTA on all clinical and quality of life measures and a favorable benefit‐risk ratio in subsequent PREEMPT pooled subgroup analysis of CM patients with or without MOH 13–15 . Real‐world data have also been consistent with the positive benefit‐risk profile of BoNTA ascertained in all PREEMPT‐based publications, in addition to demonstrating improvements on patient‐reported outcomes (PROs), 16 even in the context of direct head‐to‐head comparison with topiramate 17 . Finally, real‐world long‐term experience with BoNTA in CM patients for up to four years of treatment supports its sustained efficacy and adequate safety and tolerability over time 18–20 …”

“…[13][14][15] Real-world data have also been consistent with the positive benefit-risk profile of BoNTA ascertained in all PREEMPT-based publications, in addition to demonstrating improvements on patientreported outcomes (PROs), 16 even in the context of direct head-tohead comparison with topiramate. 17 Finally, real-world long-term experience with BoNTA in CM patients for up to four years of treatment supports its sustained efficacy and adequate safety and tolerability over time. [18][19][20] We have previously reported that a total of 65/81 (80.2%) patients were classified as either 50% or 75% responders after receiving 3 treatment cycles of 155 U-195 U BoNTA with a corresponding significant improvement in all clinical efficacy measures, including reduction of mean headache days/month, days with peak headache intensity >4/10, as well as intake of acute headache medications per month, compared with baseline.…”

OnabotulinumtoxinA: Still the Present for Chronic Migraine

“…Several real-world studies have been published, with findings consistent with PREEMPT studies in CM patients with and without MOH [ 80 , 81 , 82 , 83 , 84 , 85 , 86 , 87 , 88 , 89 , 90 , 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 , 107 , 108 , 109 , 110 , 111 , 112 , 113 , 114 , 115 , 116 , 117 , 118 , 119 , 120 , 121 , 122 , 123 , 124 , 125 , 126 , 127 ]. Real-world studies primarily exploring the effectiveness and safety of BT-A compared to the baseline are summarized in Table 2 .…”

OnabotulinumtoxinA for the treatment of headache: an updated review

“…Well-controlled clinical trials have shown that patients with overuse of headache medication can be treated successfully with onabotulinumtoxinA and topiramate [45]. Comparative studies have shown that onabotulinumtoxinA is an effective and safe alternative for the treatment of chronic migraine in patients who discontinue topiramate treatment and can be started during the tapering of topiramate [46,47]. It should be noted however that combining classic migraine therapy with onabotulinum-toxinA injection should be avoided in order to allow a better understanding of the efficacy of each treatment in the individual patient.…”