Erenumab in chronic migraine with medication overuse

Subgroup analysis of a randomized trial

Stewart J. Tepper, Hans Christoph Diener, Messoud Ashina, Jan Lewis Brandes, Deborah I Friedman, Uwe Reuter, Sunfa Cheng, Jon Nilsen, Dean K. Leonardi, Robert A. Lenz, Daniel D. Mikol

Research output: Contribution to journalArticle

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Abstract

OBJECTIVE: To determine the effect of erenumab, a human anti-calcitonin gene-related peptide receptor monoclonal antibody, in patients with chronic migraine and medication overuse. METHODS: In this double-blind, placebo-controlled study, 667 adults with chronic migraine were randomized (3:2:2) to placebo or erenumab (70 or 140 mg), stratified by region and medication overuse status. Data from patients with baseline medication overuse at baseline were used to assess changes in monthly migraine days, acute migraine-specific medication treatment days, and proportion of patients achieving ≥50% reduction from baseline in monthly migraine days. RESULTS: Of 667 patients randomized, 41% (n = 274) met medication overuse criteria. In the medication overuse subgroup, erenumab 70 or 140 mg groups had greater reductions than the placebo group at month 3 in monthly migraine days (mean [95% confidence interval] -6.6 [-8.0 to -5.3] and -6.6 [-8.0 to -5.3] vs -3.5 [-4.6 to -2.4]) and acute migraine-specific medication treatment days (-5.4 [-6.5 to -4.4] and -4.9 [-6.0 to -3.8] vs -2.1 [-3.0 to -1.2]). In the placebo and 70 and 140 mg groups, ≥50% reductions in monthly migraine days were achieved by 18%, 36% (odds ratio [95% confidence interval] 2.67 [1.36-5.22]) and 35% (odds ratio 2.51 [1.28-4.94]). These clinical responses paralleled improvements in patient-reported outcomes with a consistent benefit of erenumab across multiple measures of impact, disability, and health-related quality of life. The observed treatment effects were similar in the non-medication overuse subgroup. CONCLUSIONS: Erenumab reduced migraine frequency and acute migraine-specific medication treatment days in patients with chronic migraine and medication overuse, improving disability and quality of life. CLINICALTRIALSGOV IDENTIFIER: NCT02066415. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that erenumab reduces monthly migraine days at 3 months in patients with chronic migraine and medication overuse.

Original languageEnglish (US)
Pages (from-to)e2309-e2320
JournalNeurology
Volume92
Issue number20
DOIs
StatePublished - May 14 2019

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Migraine Disorders
Placebos
Prescription Drug Overuse
Odds Ratio
Quality of Life
Calcitonin Gene-Related Peptide Receptors
Confidence Intervals
Therapeutics
Monoclonal Antibodies

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Tepper, S. J., Diener, H. C., Ashina, M., Brandes, J. L., Friedman, D. I., Reuter, U., ... Mikol, D. D. (2019). Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial. Neurology, 92(20), e2309-e2320. https://doi.org/10.1212/WNL.0000000000007497

Erenumab in chronic migraine with medication overuse : Subgroup analysis of a randomized trial. / Tepper, Stewart J.; Diener, Hans Christoph; Ashina, Messoud; Brandes, Jan Lewis; Friedman, Deborah I; Reuter, Uwe; Cheng, Sunfa; Nilsen, Jon; Leonardi, Dean K.; Lenz, Robert A.; Mikol, Daniel D.

In: Neurology, Vol. 92, No. 20, 14.05.2019, p. e2309-e2320.

Research output: Contribution to journalArticle

Tepper, SJ, Diener, HC, Ashina, M, Brandes, JL, Friedman, DI, Reuter, U, Cheng, S, Nilsen, J, Leonardi, DK, Lenz, RA & Mikol, DD 2019, 'Erenumab in chronic migraine with medication overuse: Subgroup analysis of a randomized trial', Neurology, vol. 92, no. 20, pp. e2309-e2320. https://doi.org/10.1212/WNL.0000000000007497
Tepper, Stewart J. ; Diener, Hans Christoph ; Ashina, Messoud ; Brandes, Jan Lewis ; Friedman, Deborah I ; Reuter, Uwe ; Cheng, Sunfa ; Nilsen, Jon ; Leonardi, Dean K. ; Lenz, Robert A. ; Mikol, Daniel D. / Erenumab in chronic migraine with medication overuse : Subgroup analysis of a randomized trial. In: Neurology. 2019 ; Vol. 92, No. 20. pp. e2309-e2320.
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T2 - Subgroup analysis of a randomized trial

AU - Tepper, Stewart J.

AU - Diener, Hans Christoph

AU - Ashina, Messoud

AU - Brandes, Jan Lewis

AU - Friedman, Deborah I

AU - Reuter, Uwe

AU - Cheng, Sunfa

AU - Nilsen, Jon

AU - Leonardi, Dean K.

AU - Lenz, Robert A.

AU - Mikol, Daniel D.

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N2 - OBJECTIVE: To determine the effect of erenumab, a human anti-calcitonin gene-related peptide receptor monoclonal antibody, in patients with chronic migraine and medication overuse. METHODS: In this double-blind, placebo-controlled study, 667 adults with chronic migraine were randomized (3:2:2) to placebo or erenumab (70 or 140 mg), stratified by region and medication overuse status. Data from patients with baseline medication overuse at baseline were used to assess changes in monthly migraine days, acute migraine-specific medication treatment days, and proportion of patients achieving ≥50% reduction from baseline in monthly migraine days. RESULTS: Of 667 patients randomized, 41% (n = 274) met medication overuse criteria. In the medication overuse subgroup, erenumab 70 or 140 mg groups had greater reductions than the placebo group at month 3 in monthly migraine days (mean [95% confidence interval] -6.6 [-8.0 to -5.3] and -6.6 [-8.0 to -5.3] vs -3.5 [-4.6 to -2.4]) and acute migraine-specific medication treatment days (-5.4 [-6.5 to -4.4] and -4.9 [-6.0 to -3.8] vs -2.1 [-3.0 to -1.2]). In the placebo and 70 and 140 mg groups, ≥50% reductions in monthly migraine days were achieved by 18%, 36% (odds ratio [95% confidence interval] 2.67 [1.36-5.22]) and 35% (odds ratio 2.51 [1.28-4.94]). These clinical responses paralleled improvements in patient-reported outcomes with a consistent benefit of erenumab across multiple measures of impact, disability, and health-related quality of life. The observed treatment effects were similar in the non-medication overuse subgroup. CONCLUSIONS: Erenumab reduced migraine frequency and acute migraine-specific medication treatment days in patients with chronic migraine and medication overuse, improving disability and quality of life. CLINICALTRIALSGOV IDENTIFIER: NCT02066415. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that erenumab reduces monthly migraine days at 3 months in patients with chronic migraine and medication overuse.

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