Abstract
BackgroundThere is a need to establish which are the more relevant headache-related outcomes that have an impact on our patient’s lives to accurately evaluate treatment response in daily clinical practice.ObjectiveThe aim of this study was to evaluate the relevance of clinical trial endpoints in clinical real-life disability improvement in response to migraine preventive treatment with OnabotulinumtoxinA.MethodsThis is an observational prospective study. We included patients with chronic migraine fulfilling ICHD-3beta/3 criteria. We prospectively collected data of 8 headache-related and acute medication use endpoints recommended by the Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine. We evaluated their impact on disability improvement after 6 months of treatment with OnabotulinumtoxinA. We defined as a responder in disability, patients with ≥50% MIDAS score reduction after 2 cycles of treatment following PREEMPT protocol. We performed an analysis to measure the impact of improvement in the evaluated outcome measures according to perceived disability in clinical practice.ResultsWe included 395 patients (85.1% women, mean age 46.7 ± 12.6 years). Mean headache frequency at baseline was 26.5 ± 5.2 headache days/month. After 6 months, 49.1% of patients were headache-related disability responders. From all outcome measures collected, variables independently associated to disability improvement were headache days reduction (p = 0.02) and ≥ 50% pain intensity reduction (p = 0.04). A ≥ 50% reduction in headache frequency or pain intensity showed similar influence on disability improvement after treatment.ConclusionsHeadache pain intensity is as important as frequency when evaluating the clinical response and impact on patient headache-related disability after migraine preventive treatment with OnabotulinumtoxinA.
Highlights
Chronic migraine, is a prevalent and highly disabling neurological disease [1]
Moderate to severe headache days were decreased from 12.7 ± 7.5 to 6.7 ± 6.0 days/month (p < 0.001) and 54.2% (214/395) showed a ≥ 50% reduction in moderate to severe days
We demonstrate in a clinical sample of patients with chronic migraine that, after 6 months of treatment with OnabotulinumtoxinA, headache frequency reduction is not the only outcome independently associated with Migraine Disability Assessment Test (MIDAS) improvement and pain intensity, and should be considered as a major clinical outcome measure
Summary
Chronic migraine, is a prevalent and highly disabling neurological disease [1]. Suffering recurrent migraine attacks produces an abrupt and non-predictable functional disruption of daily life and entails an overwhelming decrease in the patient’s quality of life with a clear negative impact on a personal, family, working, social and economic level. OnabotulinumtoxinA is an effective chronic migraine preventive therapy that improves disability by reducing quantifiable outcome measures, as headache frequency, duration or attack intensity [2, 3]. As with other migraine preventive treatments, the use of OnabotulinumtoxinA may decrease visits to outpatient clinics, emergency departments and neuroimaging tests proving to be cost-effective [5, 6]. All these clinical and economical potential effects should be considered when we evaluate treatment effectiveness. There is a need to establish which are the more relevant headache-related outcomes that have an impact on our patient’s lives to accurately evaluate treatment response in daily clinical practice
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