OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program

Lipton, Richard B.; Rosen, Noah; Ailani, Jessica; DeGryse, Ronald; Gillard, Patrick; Varon, Sepideh F.

doi:10.1177/0333102416652092

Cited by 77 publications

(73 citation statements)

References 28 publications

(72 reference statements)

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“…Both CM and HFEM are associated with high disability, impact and reduced quality of life. In our cohort, disability was assessed at each time point using the HIT-6 and MIDAS scales, showing a significant reduction in MIDAS score from baseline to month 24 in CM, as had been previously demonstrated [29]. Our data also reproduce the long-term benefit seen in other cohorts [25,26].…”

Section: Discussionsupporting

confidence: 84%

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

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Background and purpose The aim was to analyse the clinical characteristics of a long‐term follow‐up of patients with chronic and high‐frequency episodic migraine in treatment with onabotulinumtoxinA. Methods Patients diagnosed with high‐frequency episodic migraine (HFEM) or chronic migraine (CM) according to the International Classification of Headache Disorders 3 beta were included. A comparative analysis was carried out at each study time point identifying outcome measures according to initial diagnosis and treatment duration. Results In all, 578 patients were recruited and after 24 months outcome data were collected from 100 patients: 84.0% CM and 16.0% HFEM. After 24 months, headache frequency was significantly reduced by 10.5 days from baseline, 64.0% reported a ≥50% reduction in pain intensity and 70.0% of patients had ≥50% reduction in analgesic use. Comparing baseline diagnoses, at month 6 CM patients presented higher mean reduction in frequency (CM 44.3% ± 32.6% vs. HFEM 34.6% ± 24.8%) and analgesic use (CM 53.6% ± 35.4% vs. HFEM 39.3% ± 33.2%). At month 12, the mean reduction in frequency was similar in CM and HFEM patients (CM 44.7% ± 33.4% vs. HFEM 41.2% ± 28.2%). Improvement in pain intensity, analgesic use and Migraine Disability Assessment were proportional in both diagnoses. Conclusions OnabotulinumtoxinA efficacy is significant at 6 months in frequency and analgesic intake and remains stable during follow‐up, whilst the intensity of pain decreases in a stepwise manner at each time point of the analysis. The improvement in CM and HFEM patients is proportional and significant after 1 year of treatment.

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Section: Discussionsupporting

confidence: 84%

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Alpuente

Gallardo

Torres‐Ferrús

et al. 2019

Euro J of Neurology

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“…Subsequent exploratory and confirmatory factor analysis and patient interviews reduced the number of items to 14, which revealed and confirmed 3 meaningful domains measured by the MSQ: Role Function‐Restrictive (RFR), Role Function‐Preventive (RFP), and Emotional Function (EF) . Overall, the rigorous development and strong psychometric properties of the MSQ have resulted in extensive research, including numerous clinical trials spanning more than 2 decades . The MSQ is recommended as a core instrument for headache studies by the National Institutes of Health…”

Section: Introductionmentioning

confidence: 99%

“…This instrument is widely used, has been shown to correlate highly with the MSQ and other migraine measures of disability, and is a reliable and valid tool for discriminating headache impact across both episodic and chronic migraine . Evidence from migraine prevention trials has demonstrated that HIT‐6 is sensitive to treatment effects …”

Section: Introductionmentioning

confidence: 99%

Measures of Functioning in Patients With Episodic Migraine: Findings From a Double‐Blind, Randomized, Placebo‐Controlled Phase 2b Trial With Galcanezumab

et al. 2018

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Objective - To evaluate 12-week changes from baseline of 2 disease-specific patient-reported outcome (PRO) measures in adults with migraine treated with galcanezumab, an investigational humanized antibody binding calcitonin gene-related peptide (CGRP), or placebo. Background - Preventing headache-related functional impairment is an important goal of migraine preventive treatment and a measurement target for PROs. Understanding which drugs have the potential to improve patient functioning in addition to preventing migraine headaches is vital to lessening patient burden. Design/Methods - This Phase 2b double-blind, randomized, placebo-controlled study enrolled adults with episodic migraine. Galcanezumab (120 mg subcutaneous injection; n = 60) or placebo (n = 127) was administered every 28 days for 12 weeks. Post hoc secondary analyses were conducted for those who completed 12 weeks of treatment on 2 PROs: The Migraine-Specific Quality of Life Questionnaire (MSQ) v2.1 and the Headache Impact Test™ (HIT-6). Results - Analysis of covariance revealed significant differences in least square mean changes from baseline between galcanezumab and placebo for all MSQ domains including total mean change placebo of 18.63, galcanezumab of 27.36 (95% CI 2.449, 15.008; P-value of .0067); Role Function-Restrictive mean change placebo of 22.40, galcanezumab of 31.92 (95% CI 2.636, 16.518; P-value of .0071); Role Function-Preventive mean change placebo of 13.43, galcanezumab of 19.76 (95% CI 0.476, 12.185; P-value of .0342); and Emotional Function mean change placebo of 16.88, galcanezumab of 26.61 (95% CI 2.789, 16.674; P-value of .0063). At baseline, mean number of migraine headache days (MHDs) did not correlate with MSQ total scores or HIT-6. At 12 weeks post-treatment, MHD correlated with MSQ and HIT-6 scores (all P < .0001). Change in MHD was associated with change in MSQ domains and change in HIT-6 scores (all P < .0001). Conclusions - In comparison with placebo, treatment with galcanezumab was associated with significant functional improvements as reflected by changes in MSQ scores. Change in MHD was associated with improvements in MSQ and reductions in HIT-6 scores, indicating the clinical importance of these changes in relation to PROs that measure function.

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“…In the United States, chronic migraine prevalence is nearly 1% and results in enormous impact on headache-related disability, including higher Migraine Disability Assessment Test (MIDAS), reduced health-related quality of life (HRQoL), increased depression and anxiety (PHQ-4 and GAD-7 respectively), compared to episodic migraine [1–6]. Chronic migraine has also been shown to result in greater economic burden and health care resource utilization [1, 3, 7–9]. Annually, the total economic cost of chronic migraine is over three time that of episodic migraine, when consider direct medical costs and loss from decreased productivity [8].…”

Section: Introductionmentioning

confidence: 99%

Intravenous ketamine for subacute treatment of refractory chronic migraine: a case series

et al. 2016

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BackgroundRefractory migraine is a challenging condition with great impact on health related quality of life. Intravenous (IV) ketamine has been previously used to treat various refractory pain conditions. We present a series of patients with refractory migraine treated with intravenous ketamine in the hospital setting.MethodsBased on retrospective chart review, we identified six patients with refractory migraine admitted from 2010 through 2014 for treatment with intravenous ketamine. Ketamine was administered using a standard protocol starting with a dose of 0.1 mg/kg/hr and increased by 0.1 mg/kg/hr every 3 to 4 h as tolerated until the target pain score of 3/10 was achieved and maintained for at least 8 h. Visual Analogue Scale (VAS) scores at time of hospital admission were obtained as well as average baseline VAS scores prior to ketamine infusion. A phone interview was conducted for follow-up of migraine response in the 3 to 6 months following ketamine infusion.ResultsThe study sample had a median age of 36.5 years (range 29–54) and 83% were women. Pre-treatment pain scores ranged from 9 to 10. All patients achieved a target pain level of 3 or less for 8 h; the average ketamine infusion rate at target was 0.34 mg/kg/hour (range 0.12–0.42 mg/kg/hr). One patient reported a transient out-of-body hallucination following an increase in the infusion rate, which resolved after decreasing the rate. There were no other significant side effects.ConclusionIV ketamine was safely administered in the hospital setting to patients with refractory chronic migraine. Treatment was associated with short term improvement in pain severity in 6 of 6 patients with refractory chronic migraine. Prospective placebo-controlled trials are needed to assess short term and long-term efficacy of IV ketamine in refractory chronic migraine.Electronic supplementary materialThe online version of this article (doi:10.1186/s10194-016-0700-3) contains supplementary material, which is available to authorized users.

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OnabotulinumtoxinA improves quality of life and reduces impact of chronic migraine over one year of treatment: Pooled results from the PREEMPT randomized clinical trial program

Cited by 77 publications

References 28 publications

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Early efficacy and late gain in chronic and high‐frequency episodic migraine with onabotulinumtoxinA

Measures of Functioning in Patients With Episodic Migraine: Findings From a Double‐Blind, Randomized, Placebo‐Controlled Phase 2b Trial With Galcanezumab

Intravenous ketamine for subacute treatment of refractory chronic migraine: a case series

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