Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability

Janet H. Ford, David W. Ayer, Qi Zhang, Jeffrey N. Carter, Elizabeth Leroux, Vladimir Skljarevski, Sheena K. Aurora, Antje Tockhorn-Heidenreich, Richard B. Lipton

Research output: Contribution to journalArticle

Abstract

OBJECTIVE: To evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo. METHODS: Patients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only). RESULTS: Differences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = -6.3 (p < 0.001) and -5.2 (p = 0.002); EVOLVE-2 = -9.2 and -8.2 (both p < 0.001). CONCLUSIONS: Patients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

Original languageEnglish (US)
Pages (from-to)e508-e517
JournalNeurology
Volume93
Issue number5
DOIs
StatePublished - Jul 30 2019

Fingerprint

Migraine Disorders
Placebos
Quality of Life
Least-Squares Analysis
Headache

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Two randomized migraine studies of galcanezumab : Effects on patient functioning and disability. / Ford, Janet H.; Ayer, David W.; Zhang, Qi; Carter, Jeffrey N.; Leroux, Elizabeth; Skljarevski, Vladimir; Aurora, Sheena K.; Tockhorn-Heidenreich, Antje; Lipton, Richard B.

In: Neurology, Vol. 93, No. 5, 30.07.2019, p. e508-e517.

Research output: Contribution to journalArticle

Ford, JH, Ayer, DW, Zhang, Q, Carter, JN, Leroux, E, Skljarevski, V, Aurora, SK, Tockhorn-Heidenreich, A & Lipton, RB 2019, 'Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability', Neurology, vol. 93, no. 5, pp. e508-e517. https://doi.org/10.1212/WNL.0000000000007856
Ford JH, Ayer DW, Zhang Q, Carter JN, Leroux E, Skljarevski V et al. Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability. Neurology. 2019 Jul 30;93(5):e508-e517. https://doi.org/10.1212/WNL.0000000000007856
Ford, Janet H. ; Ayer, David W. ; Zhang, Qi ; Carter, Jeffrey N. ; Leroux, Elizabeth ; Skljarevski, Vladimir ; Aurora, Sheena K. ; Tockhorn-Heidenreich, Antje ; Lipton, Richard B. / Two randomized migraine studies of galcanezumab : Effects on patient functioning and disability. In: Neurology. 2019 ; Vol. 93, No. 5. pp. e508-e517.
@article{e9ea3b7b2ab54e8abd9bb910587ed4c8,
title = "Two randomized migraine studies of galcanezumab: Effects on patient functioning and disability",
abstract = "OBJECTIVE: To evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo. METHODS: Patients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only). RESULTS: Differences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = -6.3 (p < 0.001) and -5.2 (p = 0.002); EVOLVE-2 = -9.2 and -8.2 (both p < 0.001). CONCLUSIONS: Patients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.",
author = "Ford, {Janet H.} and Ayer, {David W.} and Qi Zhang and Carter, {Jeffrey N.} and Elizabeth Leroux and Vladimir Skljarevski and Aurora, {Sheena K.} and Antje Tockhorn-Heidenreich and Lipton, {Richard B.}",
year = "2019",
month = "7",
day = "30",
doi = "10.1212/WNL.0000000000007856",
language = "English (US)",
volume = "93",
pages = "e508--e517",
journal = "Neurology",
issn = "0028-3878",
publisher = "Lippincott Williams and Wilkins",
number = "5",

}

TY - JOUR

T1 - Two randomized migraine studies of galcanezumab

T2 - Effects on patient functioning and disability

AU - Ford, Janet H.

AU - Ayer, David W.

AU - Zhang, Qi

AU - Carter, Jeffrey N.

AU - Leroux, Elizabeth

AU - Skljarevski, Vladimir

AU - Aurora, Sheena K.

AU - Tockhorn-Heidenreich, Antje

AU - Lipton, Richard B.

PY - 2019/7/30

Y1 - 2019/7/30

N2 - OBJECTIVE: To evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo. METHODS: Patients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only). RESULTS: Differences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = -6.3 (p < 0.001) and -5.2 (p = 0.002); EVOLVE-2 = -9.2 and -8.2 (both p < 0.001). CONCLUSIONS: Patients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

AB - OBJECTIVE: To evaluate changes from baseline in patient-reported outcomes for measures of functioning and disability among patients with migraine treated with galcanezumab or placebo. METHODS: Patients with episodic migraine (4-14 monthly migraine headache days) were treated with either galcanezumab (Evaluation of LY2951742 in the Prevention of Episodic Migraine [EVOLVE]-1: 120 mg n = 210, 240 mg n = 208; EVOLVE-2: 120 mg n = 226, 240 mg n = 220) or placebo (EVOLVE-1 n = 425; EVOLVE-2 n = 450) during 6 months of treatment. Migraine-Specific Quality of Life Questionnaire v2.1 (MSQv2.1) measured the effect of migraine on patient functioning (physical and emotional) in 3 domains, and the Migraine Disability Assessment (MIDAS) quantified headache-related disability associated with missed or reduced productivity at work or home and social events. Both were collected at baseline and during the treatment period (MSQv2.1 = monthly; MIDAS = months 3 and 6 only). RESULTS: Differences in MSQv2.1 total score least squares (LS) mean change from baseline (month 4-6) for galcanezumab (120 and 240 mg, respectively) were superior to placebo (EVOLVE-1 = 7.3 and 6.7 [both p < 0.001]; EVOLVE-2 = 8.5 and 7.3 [both p < 0.001]). Differences were similar for all domain scores (p < 0.001 for both galcanezumab doses compared with placebo), were observed as early as month 1, and were sustained for 6 months for most domains. Differences of MIDAS LS mean change from baseline (month 6) for galcanezumab (120 and 240 mg, respectively) compared with placebo were: EVOLVE-1 = -6.3 (p < 0.001) and -5.2 (p = 0.002); EVOLVE-2 = -9.2 and -8.2 (both p < 0.001). CONCLUSIONS: Patients with episodic migraine treated with galcanezumab reported significant and clinically meaningful improvements in daily functioning and decreased disability compared with patients who received placebo. CLASSIFICATION OF EVIDENCE: This study provides Class II evidence that for patients with migraine, galcanezumab (120 mg or 240 mg) given once monthly improved functioning and reduced disability.

UR - http://www.scopus.com/inward/record.url?scp=85070789663&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85070789663&partnerID=8YFLogxK

U2 - 10.1212/WNL.0000000000007856

DO - 10.1212/WNL.0000000000007856

M3 - Article

C2 - 31270220

AN - SCOPUS:85070789663

VL - 93

SP - e508-e517

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 5

ER -