Cycling Through Migraine Preventive Treatments: Implications for All-Cause Total Direct Costs and Disease-Specific Costs

Ford, Janet H.; Schroeder, Krista; Nyhuis, Allen W.; Foster, Stephan L.; Aurora, Sheena K.

doi:10.18553/jmcp.2018.18058

Cited by 25 publications

(37 citation statements)

References 24 publications

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“…Adherence with traditional migraine preventive therapies is generally low, with approximately 77% to 85% of patients discontinuing their initial migraine preventive medication within 1 year [7,8]. Patients who discontinue or switch preventive treatments experience a substantial burden in terms of impaired function and quality of life [9], as well as increased healthcare resource utilization and costs [7]. The most common reasons for discontinuation include lack of efficacy and poor tolerability [10].…”

Section: Introductionmentioning

confidence: 99%

Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study

et al. 2020

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Background: The long-term safety and efficacy of fremanezumab were evaluated in a 52-week extension study (NCT02638103). Patient satisfaction with fremanezumab, dosing preferences, and patient-reported outcomes were assessed in a subpopulation who completed the extension study and consented to a follow-up questionnaire. Methods: In the extension study (N = 1842), adults with migraine were randomized to quarterly or monthly fremanezumab. After completing active treatment, patients answered a survey evaluating patient satisfaction, treatment and dosing preferences, and changes in patient-reported outcomes. Results: Of the 557 patients who could have been contacted upon completing the extension study, 302 consented and 253 completed the survey. The mean (standard deviation) satisfaction rating for fremanezumab was 6.1 (1.4; 1 = "extremely dissatisfied" to 7 = "extremely satisfied"). Most patients (175 [69.2%]) preferred quarterly over monthly fremanezumab dosing. Among patients taking antiepileptics (most common class of prior preventive medication; n = 130), 91.5% preferred fremanezumab. Patients reported improvements in anxiety (74 [67.9%]), sleep quality (143 [56.5%]), and quality of time spent with others (210 [83.0%]) with fremanezumab. Conclusion: In this study, treatment satisfaction with fremanezumab was high, most patients preferred quarterly fremanezumab dosing, and fremanezumab was generally preferred to prior preventive medications.

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Section: Introductionmentioning

confidence: 99%

Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study

et al. 2020

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“…8 Oral preventive medications for migraine have been associated with suboptimal efficacy or intolerable side effects that frequently lead to poor adherence, multiple medication switches, or discontinuation; 5,6,9 as a result, many patients rely solely on acute medications for treatment of their migraine attacks. 11 Galcanezumab is a humanized monoclonal antibody that potently and selectively binds to the CGRP ligand 12,13 and is approved for the preventive treatment of migraine in adults. 10 A recent study evaluated cycling of preventive migraine medications from a claims database and found that for patients with episodic and chronic migraine, more than 75% of patients switched or discontinued their initial preventive treatment within 12 months, leading to increased healthcare resource utilization and cost.…”

Section: Introductionmentioning

confidence: 99%

“…10 A recent study evaluated cycling of preventive migraine medications from a claims database and found that for patients with episodic and chronic migraine, more than 75% of patients switched or discontinued their initial preventive treatment within 12 months, leading to increased healthcare resource utilization and cost. 11 Galcanezumab is a humanized monoclonal antibody that potently and selectively binds to the CGRP ligand 12,13 and is approved for the preventive treatment of migraine in adults. 14,15 The efficacy, safety, and tolerability of galcanezumab for migraine prevention have been established in 2 Phase 2 studies 16-18 and 3 Phase 3 studies.…”

Section: Introductionmentioning

confidence: 99%

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies

et al. 2019

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Objective.-To evaluate onset of effect of galcanezumab in patients with episodic migraine. Background.-Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide and is indicated for preventive treatment of migraine. Design/Methods.-Data on the primary outcome measure were analyzed from 2 previously published double-blind, Phase 3 studies (EVOLVE-1 [N = 858] and EVOLVE-2 [N = 915]) wherein adult patients with episodic migraine were randomized to receive monthly subcutaneous injections of galcanezumab 120 mg (with 240-mg loading dose) or 240 mg or placebo for up to 6 months. Monthly onset of effect was defined as the earliest month at which galcanezumab achieved and subsequently maintained statistical superiority to placebo on the mean change from baseline in the number of monthly migraine headache days (MHDs). If onset occurred in Month 1, weekly onset was evaluated and defined as the earliest week at which galcanezumab statistically separated from placebo and maintained statistical separation for remaining weeks in that month. Day of onset of effect was also analyzed, as were monthly and weekly onset, for occurrence of ≥50% reduction from baseline in number of MHDs. Results.-For both studies, change from baseline in monthly MHDs showed a statistically significant separation of galcanezumab from placebo at Month 1 and each subsequent month (each P < .001). Analysis of the first month for both studies indicated onset of effect in the first week, with galcanezumab-treated patients having significantly higher odds of having fewer MHDs in the first week (odds ratio [95% confidence interval] for EVOLVE-1, 2.71 [2.00, 3.66], and for EVOLVE-2, 2.88 [2.16, 3.86]; both P < .001) and each subsequent week compared with placebo-treated patients (P ≤ .004). Daily analysis showed onset of effect at Day 1 (first day after injection day). Galcanezumab also demonstrated superiority to placebo on occurrence of ≥50% reduction in MHDs starting at Week 1 (percentage of patients with 50% response in galcanezumab group vs placebo group for EVOLVE-1, 54.3% vs 32.4% [P < .001], and for EVOLVE-2, 59.4% vs 38.0% [P < .001]). Conclusion.-Rapid onset of preventive effect on the first day after injection of galcanezumab was confirmed in both studies of episodic migraine.This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

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“…Lack of effectiveness and intolerability often result in multiple medication switches, poor adherence or discontinuation . A recent study in patients with episodic or chronic migraine reported that >75% of patients switched or discontinued their initial preventive treatment .…”

Section: Introductionmentioning

confidence: 99%

Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double‐blind studies

Ailani

Pearlman

Zhang

et al. 2019

Euro J of Neurology

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Background and purpose Humanized monoclonal antibody galcanezumab, which binds to calcitonin‐gene‐related peptide, has shown efficacy for episodic and chronic migraine prevention. These analyses evaluated galcanezumab response for migraine headache prevention in patients who previously failed onabotulinumtoxinA (‘nonresponse’ or ‘inadequate response’ or safety reasons). Methods Post hoc analyses included data from three double‐blind, placebo‐controlled, phase 3 episodic or chronic migraine studies; 2886 patients randomly received 120 or 240 mg galcanezumab or placebo. During double‐blind periods the study drug was administered subcutaneously once a month for 6 months in EVOLVE‐1 and ‐2 and for 3 months in REGAIN. The 120 mg groups received a 240 mg loading dose at month 1. Pooled analyses included 129 patients who failed onabotulinumtoxinA. Using mixed effect model repeat measurements, the least squares mean change from baseline in the number of migraine headache days (MHDs) was calculated for the first 3 months of treatment. Results For pooled analyses, significant decreases from baseline in the number of MHDs were observed for 120 mg (−3.91) and 240 mg (−5.27) galcanezumab overall versus placebo (−0.88) across 3‐month time points for patients who failed onabotulinumtoxinA. Corresponding data for patients with chronic migraine showed significant decreases: 120 mg (−3.18) and 240 mg (−4.26) galcanezumab versus placebo (0.16). Significant reductions in the number of MHDs per month with acute medication use included 120 mg galcanezumab (−4.35) and 240 mg galcanezumab (−4.55) versus placebo (−0.83). Estimates of ≥50% response during months 1–3 were 9.4% for placebo, 41.3% for 120 mg galcanezumab and 47.5% for 240 mg galcanezumab. Conclusion Galcanezumab is an option for prevention of migraine in patients who have previously failed onabotulinumtoxinA preventive therapy.

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Cycling Through Migraine Preventive Treatments: Implications for All-Cause Total Direct Costs and Disease-Specific Costs

Cited by 25 publications

References 24 publications

Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study

Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study

Rapid Onset of Effect of Galcanezumab for the Prevention of Episodic Migraine: Analysis of the EVOLVE Studies

Positive response to galcanezumab following treatment failure to onabotulinumtoxinA in patients with migraine: post hoc analyses of three randomized double‐blind studies

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