Prospective real‐world analysis of OnabotulinumtoxinA in chronic migraine post‐National Institute for Health and Care Excellence UK technology appraisal

Andreou, Anna P.; Trimboli, Michele; Al‐Kaisy, Adnan; Murphy, M Stephen; Palmisani, Stefano; Fenech, Cherilyn; Smith, Thomas J.; Lambru, Giorgio

doi:10.1111/ene.13657

Cited by 41 publications

(42 citation statements)

References 20 publications

(22 reference statements)

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“…Although headache intensity is also considered a secondary outcome measure to evaluate preventive treatment response in clinical trials as well as clinical practice [ 7 , 19 ], the vast majority of clinical real-life published studies that evaluate OnabotulinumtoxinA treatment response in different conditions, do not include the evaluation of headache pain intensity [ 20 ]. Besides, current clinical treatment guidelines for migraine prevention, define response to treatment based only in headache frequency reduction [ 21 – 23 ], even recommending to stop treatment if the frequency does not decrease in patients.…”

Section: Discussionmentioning

confidence: 99%

Influence of headache pain intensity and frequency on migraine-related disability in chronic migraine patients treated with OnabotulinumtoxinA

et al. 2020

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Background: 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. Objective: The 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. Methods: This 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. Results: We 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. Conclusions: Headache 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.

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Section: Discussionmentioning

confidence: 99%

Influence of headache pain intensity and frequency on migraine-related disability in chronic migraine patients treated with OnabotulinumtoxinA

et al. 2020

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“…Andreou et al analyzed the effects of BoNTA discontinuation in clinical practice [7]. Sixty-eight of 200 patients reverted to an episodic migraine pattern after two treatment cycles and were willing to stop treatment.…”

Section: Discussionmentioning

confidence: 99%

“…In clinical practice, patients often suffer from a rebound phenomenon, i.e. a renewed increase of migraine frequency after the termination of prophylactic therapy [5, 7].…”

Section: Introductionmentioning

confidence: 99%

Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination

et al. 2019

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BackgroundMonoclonal antibodies (mAbs) targeting the CGRP pathway are safe and efficacious therapies for the prevention of migraine. In this study we assessed the effects of discontinuation of preventive erenumab and galcanezumab treatment in patients with chronic migraine.MethodsThis retrospective pooled analysis included completers of the open-label extension study phase for the preventive treatment of chronic migraine with galcanezumab (NCT02614261; 9 months) and erenumab (NCT02174861; 12 months) in a single headache center. We compare migraine data until week 12 after open-label treatment completion, when patients did not have any pharmacological preventive medication, to study baseline values of the double-blind trial period, and to the last 4 weeks of the open-label extension. The assessment included changes in monthly migraine days, headache hours, days with severe headache and acute headache medication use.ResultsData from 16 patients after galcanezumab (n = 9) and erenumab (n = 7) open-label treatment completion were analyzed. The mean number of monthly migraine days was 18.38 ± 3.74 at baseline, and 12.19 ± 4.53 in the last 4 weeks of the open-label extension (p < 0.001). Monthly migraine days remained significantly reduced compared to baseline during the entire 12-week observation period after open-label termination (p = 0.002), with a reduction of 5.38 ± 4.92 in weeks 1–4 (p = 0.001), 4.75 ± 4.15 in weeks 5–8 (p = 0.001), and 3.93 ± 5.45 in weeks 9–12 (p = 0.014). There was no significant difference in monthly migraine days between the 12 weeks after open-label termination and the last 4 weeks of the open-label phase (p = 0.228). All other analyses revealed numerical improvement through week 12 in comparison to baseline.ConclusionsIn this small, self-selected cohort, the results indicate a therapeutic effect of monoclonal antibodies targeting the CRGP pathway in chronic migraine prevention after treatment termination up to 12 weeks.

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“…Patients in these trials did not receive formal explanation about withdrawal as part of the study protocol. After the approval of OBT‐A for chronic migraine, smaller open‐label, prospective studies advocated for the use of OBT‐A for chronic migraine with medication overuse because of good tolerability, and good outcomes on QoL and headache frequency with reduction of acute medication intake 134‐137 . The results of the aforementioned negative blinded Dutch trial challenges these results 121 …”

Section: Managing the Headache Patient With Medication Overusementioning

confidence: 99%

The Many Faces of Medication‐Overuse Headache in Clinical Practice

2020

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The management of medication-overuse headache (MOH) is multifaceted and headache experts have different views on the optimal strategy to tackle this type of secondary headache. The purpose of this review is to provide an overview of the literature on the management of MOH, and to highlight important considerations in the clinical evaluation of the MOH patient.Managing MOH in clinical practice starts by evaluating the headache patient with medication overuse, determining the overused drug(s), assessing the impact of headaches on the patient and assessing comorbid conditions and disorders. Withdrawal of the overused medication is the cornerstone of treatment. An inpatient or outpatient setting is chosen based on the clinical profile of the patient. There is evidence for abrupt withdrawal combined with headache preventive treatment.Bridging therapy to bring relief to withdrawal headaches and/or symptoms should be offered. Education and motivational work through multidisciplinary assessment show benefits in sustaining withdrawal and preventing relapse.Although the reversal of chronic headache after cessation of overused acute medication has been noticed worldwide, different aspects of the management of MOH, such as complete or gradual withdrawal, or preventive treatment with or without withdrawal are still debated.

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Prospective real‐world analysis of OnabotulinumtoxinA in chronic migraine post‐National Institute for Health and Care Excellence UK technology appraisal

Cited by 41 publications

References 20 publications

Influence of headache pain intensity and frequency on migraine-related disability in chronic migraine patients treated with OnabotulinumtoxinA

Influence of headache pain intensity and frequency on migraine-related disability in chronic migraine patients treated with OnabotulinumtoxinA

Erenumab and galcanezumab in chronic migraine prevention: effects after treatment termination

The Many Faces of Medication‐Overuse Headache in Clinical Practice

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