Is There a Gender Difference in the Response to onabotulinumtoxinA in Chronic Migraine? Insights from a Real-Life European Multicenter Study on 2879 Patients

Ornello, Raffaele; Ahmed, Fayyaz; Negro, Andrea; Miscio, Anna Maria; Santoro, Antonio; Alpuente, Alicia; Russo, Antonio; Silvestro, Marcello; Cevoli, Sabina; Brunelli, Nicoletta; Vernieri, Fabrizio; Grazzi, Licia; Baraldi, Carlo; Guerzoni, Simona; Andreou, Anna P.; Lambru, Giorgio; Kamm, Katharina; Ruscheweyh, Ruth; Russo, Marco; Torelli, Paola; Филатова, Е. Г.; Latysheva, N. V.; Gryglas-Dworak, Anna; Straburzyński, Marcin; Butera, Calogera; Colombo, Bruno; Filippi, Massimo; Pozo‐Rosich, Patricia; Martelletti, Paolo; Sacco, Simona

doi:10.1007/s40122-021-00328-y

Cited by 9 publications

(9 citation statements)

References 55 publications

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“…The gender difference in BT-A response has been studied, but with conflicting results. In particular, a previous study failed to find a clear gender difference in the clinical response towards BT-A [ 27 ]. Despite its statistical significance, sex difference in the response towards BT-A is gravated by the great difference between men and women numerosity as well as a higher number of drop-outs among men; thus, the exact magnitude of this difference is difficultly detectable but, at least, questionable.…”

Section: Discussionmentioning

confidence: 99%

“…The methods of this study have been previously published, since two more articles were derived from the analysis of the present dataset [ 26 , 27 ]; this is a pooled patient-level analysis of data from real-life studies on patients with CM treated with BT-A at 16 European headache centers. The centers potentially participating in the study were first identified through a MEDLINE search of the most recent publications on BT-A treatment for CM in Europe.…”

Section: Methodsmentioning

confidence: 99%

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Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

Ornello

Baraldi

Ahmed

et al. 2022

IJERPH

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The identification of patients who can benefit the most from the available preventive treatments is important in chronic migraine. We explored the rate of excellent responders to onabotulinumtoxinA in a multicenter European study and explored the predictors of such response, according to different definitions. A pooled analysis on chronic migraineurs treated with onabotulinumtoxinA and followed-up for, at least, 9 months was performed. Excellent responders were defined either as patients with a ≥75% decrease in monthly headache days (percent-based excellent responders) or as patients with <4 monthly headache days (frequency-based excellent responders). The characteristics of excellent responders at the baseline were compared with the ones of patients with a <30% decrease in monthly headache days. Percent-based excellent responders represented about 10% of the sample, whilst frequency-based excellent responders were about 5% of the sample. Compared with non-responders, percent-based excellent responders had a higher prevalence of medication overuse and a higher excellent response rate even after the 1st and the 2nd injection. Females were less like to be frequency-based excellent responders. Chronic migraine sufferers without medication overuse and of female sex may find fewer benefits with onabotulinumtoxinA. Additionally, the excellent response status is identifiable after the first cycle.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

Ornello

Baraldi

Ahmed

et al. 2022

IJERPH

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“…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 .…”

Section: Clinical Use Of Bt-a In the Treatment Of Chronic Migrainementioning

confidence: 99%

“…Firstly, this group determined that two BT-A cycles are usually enough to establish if a patient is a responder or a non-responder to the BT-A. Indeed, patients who do not respond to the first two cycles of BT-A are unlikely to respond to the third cycle [ 125 ]. This indicates that, as BT-A effects spread rapidly, the first 6 months of treatment should be enough to establish if BT-A should be continued or not.…”

Section: Clinical Use Of Bt-a In the Treatment Of Chronic Migrainementioning

confidence: 99%

“…Adverse events (AEs) associated with BT-A are mainly local and transitory [ 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 ]. Muscular weakness, especially in the trapezius muscle, is one of the most common [ 116 ].…”

Section: Clinical Use Of Bt-a In the Treatment Of Chronic Migrainementioning

confidence: 99%

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OnabotulinumtoxinA: Still the Present for Chronic Migraine

Baraldi

Castro

Ornello

et al. 2023

Toxins

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OnabotulinumtoxinA (BT-A) is one of the few drugs approved for the preventive treatment of chronic migraine (CM). Despite this, some aspects of its mechanism of action are still a matter of debate, and the precise magnitude of BT-A effects needs to be completely elucidated. BT-A acts primarily upon trigeminal and cervical nerve endings, by inhibiting the release of inflammatory mediators such as calcitonin gene-related peptide, as well as reducing the insertion of ionotropic and metabotropic receptors into the neuronal membrane. These actions increase the depolarization threshold of trigeminal and cervical nerve fibers, thus reducing their activation. The central actions of BT-A are still a matter of debate: a retrograde axonal transport has been postulated, but not clearly assessed in humans. Clinically, the efficacy of BT-A in CM has been assessed by large, randomized placebo-controlled trials, such as the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials. Those results were also confirmed in a wide range of open-label studies, even for long-term periods. Recently, novel findings have led to a better understanding of its pharmacological actions and clinical usefulness in migraine prevention. This narrative review summarizes, updates and critically revises the available data on BT-A and its possible implementation in chronic migraine. Moreover, the current role of BT-A in CM treatment has been discussed.

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OnabotulinumtoxinA in elderly patients with chronic migraine: insights from a real-life European multicenter study

et al. 2022

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Is There a Gender Difference in the Response to onabotulinumtoxinA in Chronic Migraine? Insights from a Real-Life European Multicenter Study on 2879 Patients

Cited by 9 publications

References 55 publications

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

Excellent Response to OnabotulinumtoxinA: Different Definitions, Different Predictors

OnabotulinumtoxinA: Still the Present for Chronic Migraine

OnabotulinumtoxinA in elderly patients with chronic migraine: insights from a real-life European multicenter study

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