Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe

Matharu, Manjit; Pascual, Julio; Remahl, Ingela Nilsson; Straube, Andreas; Lum, Arlene; Davar, Gudarz; Odom, Dawn; Bennett, Lee; Proctor, Christina; Gutiérrez, Lia; Andrews, Elizabeth; Johannes, Catherine B.

doi:10.1177/0333102417724150

Cited by 42 publications

(53 citation statements)

References 18 publications

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“…[1][2][3][4][5] In the pivotal phase 3 studies, onabotu-linumtoxinA was well tolerated and few discontinued treatment because of adverse events (AEs). 10 Topiramate "immediate release" (Topamax ® , Janssen Pharmaceuticals, Inc., Titusville, NJ) is approved for prevention of migraine in adults and is commonly prescribed. 10 Topiramate "immediate release" (Topamax ® , Janssen Pharmaceuticals, Inc., Titusville, NJ) is approved for prevention of migraine in adults and is commonly prescribed.…”

Section: Introductionmentioning

confidence: 99%

“…1,[6][7][8] The favorable benefit:risk profile of onabotulinumtoxinA has been confirmed in a large 2-year open-label study 9 and a real-world study. 10 Topiramate "immediate release" (Topamax ® , Janssen Pharmaceuticals, Inc., Titusville, NJ) is approved for prevention of migraine in adults and is commonly prescribed. 11,12 A first-line preventive treatment according to practice guidelines, topiramate is associated with systemic AEs such as paresthesia, anorexia, fatigue, nausea, diarrhea, weight decrease, cognitive issues, and mood problems; AE-associated discontinuation rates can be substantial.…”

Section: Introductionmentioning

confidence: 99%

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FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

et al. 2019

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Objective To compare effectiveness of onabotulinumtoxinA and topiramate for chronic migraine (CM) prevention. Background The efficacy* of onabotulinumtoxinA and topiramate has been established in placebo‐controlled randomized clinical trials (*defined as the benefit of treatment under ideal conditions). The effectiveness* of the 2 preventive treatments, however, has not been established (*the benefit of treatment under real‐world conditions, representing a blend of efficacy and tolerability). Methods In this multicenter, randomized, parallel‐group, post‐authorization, open‐label prospective study (FORWARD; http://ClinicalTrials.gov, NCT02191579), we randomized adults with CM (1:1) to onabotulinumtoxinA 155 U every 12 weeks for 3 cycles or topiramate “immediate release” 50‐100 mg/day to week 36. Primary outcome measure was proportion of patients achieving ≥50% reduction in headache days (weeks 29‐32). Missing values were imputed using baseline observation carried forward (BOCF) methodology. After 12 weeks, patients initially randomized to topiramate could cross over to onabotulinumtoxinA treatment. We monitored and recorded all adverse events (AEs). Results We enrolled 282 patients (onabotulinumtoxinA, n = 140; topiramate, n = 142) and 148 patients completed randomized treatment (onabotulinumtoxinA, n = 120 [86%]; topiramate, n = 28 [20%]). Primary reasons for withdrawal were ineffective treatment (onabotulinumtoxinA, n = 7 [5%]; topiramate, n = 27 [19%]) and AEs (onabotulinumtoxinA, n = 5 [4%]; topiramate, n = 72 [51%]). Eighty topiramate patients crossed over to onabotulinumtoxinA. In the BOCF analysis, a significantly higher proportion of patients randomized to onabotulinumtoxinA experienced ≥50% reduction in headache frequency compared with those randomized to topiramate (40% [56/140] vs 12% [17/142], respectively; adjusted OR, 4.9 [95% CI, 2.7‐9.1]; P < .001). OnabotulinumtoxinA was superior to topiramate in meeting secondary endpoints. In a post hoc analysis using observed data, the 50% responder rates at week 12 were 45.6% for onabotulinumtoxinA (n = 125) and 29.4% for topiramate (n = 109) (P = .015). AEs were reported by 48% (105/220) of onabotulinumtoxinA and 79% (112/142) of topiramate patients. Results were similar in those who crossed over to onabotulinumtoxinA. Conclusions While using imputation methods of accounting for differences in discontinuation rates, we found onabotulinumtoxinA to have greater clinical utility than topiramate, largely because of tolerability issues associated with the latter and a relatively higher number of onabotulinumtoxinA patients remaining on treatment.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

et al. 2019

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“…1,12 The chemical denervation by BoNTA is temporary. 21 Most clinicians that use BoNTA for CM are familiar with a wearing off effect at 10 weeks and either increase the dose to 195 units to increase the duration of effect or perform a nerve block at 10 weeks to transition to the next BoNTA treatment at 12 weeks. The PREEMPT 1 and 2 studies adopted a 12-week injection interval.…”

Section: Introductionmentioning

confidence: 99%

“…The average number of weeks between treatment sessions was 14.3 (SD 3.19) weeks and ranged from 6.0 to 51.4 weeks, with the average time between treatment sessions generally decreasing slightly with each subsequent treatment session. 21 Most clinicians that use BoNTA for CM are familiar with a wearing off effect at 10 weeks and either increase the dose to 195 units to increase the duration of effect or perform a nerve block at 10 weeks to transition to the next BoNTA treatment at 12 weeks. Shortening the treatment interval for clinicians is challenging since insurance companies often do not provide coverage in their benefits to patients when reinjections are sooner than a 12-week interval.…”

Section: Introductionmentioning

confidence: 99%

Wearing Off Effect of OnabotulinumtoxinA Near the End of Treatment Cycle for Chronic Migraine: A 4‐Year Clinical Experience

et al. 2019

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Introduction.-The injection interval for onabotulinumtoxinA (BoNTA) in the management of chronic migraine (CM) is 12 weeks (78-84 days). The aim of this study was to review patient-reported wearing off effect (WOE) of the therapeutic benefit of BoNTA near the end of the treatment cycle. We intended to describe the demographics of patients at baseline and compare groups of patients with multiple episodes of WOE.Methods.-We conducted a retrospective review of patients with CM who . The data from patient-reported WOE (worsening headache variables and neck pain) that occurred during the 4 weeks (28 days) prior to the scheduled re-injection of BoNTA for treatment cycles with injection interval ≤13 weeks and without obvious confounding factors were reviewed.Results.-We identified 98 eligible patients and analyzed 471 treatment cycles. Forty-three unique patients reported at least 1 occurrence of WOE. About 24/43 patients reported 1 WOE event and 19/43 patients reported ≥2 WOE events. Between the 2 groups, anxiety disorder and opioid use for headache were statistically significantly different. In the former group, the median interquartile range (IQR) dose of BoNTA was 165 (155, 175) units and the median IQR duration of the antinociceptive effect of BoNTA was 66.5 (63, 71.5) days. In the latter group, the median IQR dose of BoNTA was 167 (155, 173.3) units and the median IQR duration of the antinociceptive effect of BoNTA was 65.3 (62.5, 68.8) days. Up to 32% of these patients reported an increase in the use of abortive therapies to manage the symptoms of WOE. Discussion.-The primary goal of BoNTA in the treatment of CM is to mitigate the development of central sensitization. Since the 12-week injection paradigm may not provide sustained antinociceptive effect in all patients, it may account for the failure of response to BoNTA. Repeated occurrences of the WOE can potentially lead to medication overuse and impact quality of life.

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“…Some results have been obtained with oral medications, as part of a post hoc analysis 9 . Considering that the majority of headache experts also prescribe BTX‐A, 10 they would definitely take a look whether it makes sense to combine BTX‐A with anti‐CGRP antibodies. As such, we find it timely to provide a Narrative Review, in which we discuss the pathophysiological rationale for dual therapy with anti‐CGRP mAbs and BTX‐A in the prevention of migraine.…”

Section: Introductionmentioning

confidence: 99%

Dual Therapy With Anti‐CGRP Monoclonal Antibodies and Botulinum Toxin for Migraine Prevention: Is There a Rationale?

et al. 2020

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Objective.-To narratively review the pathophysiological rationale of dual therapy with anti-calcitonin gene-related peptide monoclonal antibodies and botulinum toxin type A in treatment-resistant chronic migraine prevention.Background.-For the prevention of chronic migraine, several pharmacological therapies are available, including oral medications, botulinum toxin type A, and the newly approved monoclonal antibodies targeting calcitonin gene-related peptide or its receptor. However, monotherapy does not yield benefits in some affected individuals, which raises the question of whether dual therapy with monoclonal antibodies and botulinum toxin type A hold promise in patients with treatment-resistant chronic migraine.Method.-We searched MEDLINE for articles published from database inception to December 31st, 2019. Publications were largely selected from the past 10 years but commonly referenced and highly regarded older publications were not excluded.Results.-Preclinical data suggest that anti-calcitonin gene-related peptide monoclonal antibodies and botulinum toxin type A have synergistic effects within the trigeminovascular system. Of note, findings indicate that fremanezumab -an antibody targeting the calcitonin gene-related peptide -mainly prevents the activation of Aδ-fibers, whereas botulinum toxin type A prevents the activation of C-fibers.Conclusion.-There is currently only indirect preclinical evidence to support a rationale for dual therapy with anti-calcitonin gene-related peptide monoclonal antibodies and botulinum toxin type A for chronic migraine prevention. Rigorous studies evaluating clinical efficacy, safety, and cost-effectiveness are needed. Abbreviations: BBB blood-brain barrier, BTX-A botulinum toxin typeA, CGRP calcitonin gene-related peptide, CM chronic migraine, CNS central nervous system, HT high-threshold, mAb monoclonal antibody, SNARE soluble N-ethylmaleimide-sensitive factor attachment protein receptor, TG trigeminal ganglion, TNC trigeminal nucleus caudalis, TRPA1 transient receptor potential ankyrin 1, TRPV1 transient receptor potential cation channel subfamily V member 1, WDR wide-dynamic range (

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Utilization and safety of onabotulinumtoxinA for the prophylactic treatment of chronic migraine from an observational study in Europe

Cited by 42 publications

References 18 publications

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine

Wearing Off Effect of OnabotulinumtoxinA Near the End of Treatment Cycle for Chronic Migraine: A 4‐Year Clinical Experience

Dual Therapy With Anti‐CGRP Monoclonal Antibodies and Botulinum Toxin for Migraine Prevention: Is There a Rationale?

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