Abstract
Background: Despite numerous studies that have investigated clinical, radiological, and biochemical response predictors, the clinical profile of those patients who might benefit from OnabotulinumtoxinA is still missing. The aim of the present study was to identify potential OnabotulinumtoxinA response predictors among several clinical characteristics and confirm OnabotulinumtoxinA efficacy and safety in chronic migraine (CM) prevention.Methods: The study was conducted at the Headache Center—Neurology Clinic—Spedali Civili Hospital of Brescia. Eighty-four consecutive CM patients were enrolled, with a mean age of 48 years (SD 9.7) and a mean disease duration of 10.1 years (SD 6.6). The mean reported headache-days frequency was 22.5 (SD 5.9) per month, while the mean number of severe headache-days was 15.2 (SD 8.9) with a mean monthly medication intake of 33.2 (SD 5.6). The clinical characteristics analyzed as potential response predictors were: gender, disease duration, migraine characteristics (location, side constancy, unilateral autonomic and neurovegetative symptoms), previous prophylactic treatments, add-on therapies, withdrawal therapies, psychiatric (anxiety and depression symptoms) comorbidities and medication overuse.Results: A significant reduction from baseline to 3, 6, 9, and 12 month treatment cycles in total headache days, high intensity headache days and triptans consumption per month was found. Depressive symptoms and medication overuse negatively predicted OnabotulinumtoxinA outcome.Conclusions: Our results confirm the efficacy and safety of OnabotulinumtoxinA in CM. Depressive comorbidity and medication overuse, among all clinical variables, were the only significant response predictors. Such findings provide interesting insights regarding patients selection for OnabotulinumtoxinA treatment as, with the introduction of anti calcitonin gene-related (CGRP) monoclonal antibodies, clinicians will have to thoroughly judge and tailor among the many available therapeutic options now available. Future research might be needed to confirm our findings, in particular for its therapeutic implications.
Highlights
Despite numerous studies that have investigated clinical, radiological, and biochemical response predictors, the clinical profile of those patients who might benefit from OnabotulinumtoxinA is still missing
Chronic migraine (CM), a headache occurring on ≥15 days/month for at least 3 months [1], affects ∼1.4–2.2% of adults and untold millions worldwide [2], causing greater disability compared to episodic migraine (EM) and significantly impacting quality of life [3]
Major depression, anxiety and post-traumatic stress disorder were found to be more frequent in CM than in patients with EM, as well as being significant risk factors for migraine chronification [9]
Summary
Despite numerous studies that have investigated clinical, radiological, and biochemical response predictors, the clinical profile of those patients who might benefit from OnabotulinumtoxinA is still missing. Safety and efficacy were based on the results of the Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) studies [10, 11]—two large, randomized double-blind, placebo-controlled trials—and the recent Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open Label (COMPEL) study [12]—a multicenter, openlabel long-term prospective study. These studies demonstrated that OnabotulinumtoxinA treatment significantly reduced the frequency of headache days and showed highly significant improvements in multiple headache symptom measures and in patients’ self-perceived quality of life. OnabotulinumtoxinA efficacy has been proven even in the context of CM associated with medication overuse, a frequent complication found in chronic migraneurs, encumbered by enormous treatments failure rates [18, 19]
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