Efficacy and safety of galcanezumab for the prevention of episodic migraine: Results of the EVOLVE-2 Phase 3 randomized controlled clinical trial
Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120...
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| Published in | Cephalalgia Vol. 38; no. 8; pp. 1442 - 1454 |
|---|---|
| Main Authors | , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
London, England
SAGE Publications
01.07.2018
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| Subjects | |
| Online Access | Get full text |
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| Abstract | Introduction
Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention.
Methods
A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire.
Results
Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (−2.6, −1.5) and 1.9 (−2.4, −1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo.
Conclusions
Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated.
Study identification
EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196.
Trial Registration
NCT02614196. |
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| AbstractList | Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (-2.6, -1.5) and 1.9 (-2.4, -1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo. Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated. Study identification EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196 . Trial Registration NCT02614196.Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (-2.6, -1.5) and 1.9 (-2.4, -1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo. Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated. Study identification EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196 . Trial Registration NCT02614196. Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (−2.6, −1.5) and 1.9 (−2.4, −1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo. Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated. Study identification EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196. Trial Registration NCT02614196. Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global, double-blind, 6-month study of patients with episodic migraine was undertaken with 915 intent-to-treat patients randomized to monthly galcanezumab 120 mg (n = 231) or 240 mg (n = 223) or placebo (n = 461) subcutaneous injections. Primary endpoint was overall mean change from baseline in monthly migraine headache days. Key secondary endpoints were ≥50%, ≥ 75%, and 100% response rates; monthly migraine headache days with acute migraine medication use; Patient Global Impression of Severity rating; the Role Function-Restrictive score of the Migraine-Specific Quality of Life Questionnaire. Results Mean monthly migraine headache days were reduced by 4.3 and 4.2 days by galcanezumab 120 and 240 mg, respectively, and 2.3 days by placebo. The group differences (95% CIs) versus placebo were 2.0 (-2.6, -1.5) and 1.9 (-2.4, -1.4), respectively. Both doses were superior to placebo for all key secondary endpoints. Injection site pain was the most common treatment-emergent adverse event, reported at similar rates in all treatment groups. Both galcanezumab doses had significantly more injection site reactions and injection site pruritus, and the 240 mg group had significantly more injection site erythema versus placebo. Conclusions Galcanezumab 120 or 240 mg given once monthly was efficacious, safe, and well tolerated. Study identification EVOLVE-2; NCT02614196; https://clinicaltrials.gov/ct2/show/NCT02614196 . Trial Registration NCT02614196. |
| Author | Kim, Byung-Kun Skljarevski, Vladimir Matharu, Manjit Millen, Brian A Ossipov, Michael H Yang, Jyun Yan |
| Author_xml | – sequence: 1 givenname: Vladimir surname: Skljarevski fullname: Skljarevski, Vladimir email: skljarevski_vladimir@lilly.com – sequence: 2 givenname: Manjit surname: Matharu fullname: Matharu, Manjit – sequence: 3 givenname: Brian A surname: Millen fullname: Millen, Brian A – sequence: 4 givenname: Michael H surname: Ossipov fullname: Ossipov, Michael H – sequence: 5 givenname: Byung-Kun surname: Kim fullname: Kim, Byung-Kun – sequence: 6 givenname: Jyun Yan surname: Yang fullname: Yang, Jyun Yan |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/29848108$$D View this record in MEDLINE/PubMed |
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| References | Berger, Bloudek, Varon 2012; 12 Goadsby, Edvinsson, Ekman 1988; 23 Kordzakhia, Dmitrienko 2013; 32 Iyengar, Ossipov, Johnson 2017; 158 Goadsby, Edvinsson, Ekman 1990; 28 GBD 2017; 390 Burstein, Noseda, Borsook 2015; 35 Goadsby, Holland, Martins-Oliveira 2017; 97 Goadsby, Edvinsson 1993; 33 Lassen, Haderslev, Jacobsen 2002; 22 Loder, Rizzoli 2011; 51 Goadsby, Sprenger 2010; 9 Lassen, Jacobsen, Pedersen 1998; 5 Lipton, Bigal, Diamond 2007; 68 Steiner, Stovner, Birbeck 2013; 33 Diamond, Bigal, Silberstein 2007; 47 Silberstein, Holland, Freitag 2012; 78 Lipton, Silberstein 2015; 55 Dodick, Goadsby, Spierings 2014; 13 Stauffer, Dodick, Zhang bibr12-0333102418779543 bibr19-0333102418779543 bibr6-0333102418779543 bibr14-0333102418779543 bibr17-0333102418779543 bibr8-0333102418779543 bibr10-0333102418779543 Lassen LH (bibr15-0333102418779543) 1998; 5 bibr5-0333102418779543 bibr21-0333102418779543 bibr3-0333102418779543 bibr1-0333102418779543 bibr2-0333102418779543 bibr7-0333102418779543 bibr13-0333102418779543 bibr18-0333102418779543 Stauffer VL (bibr23-0333102418779543) bibr9-0333102418779543 bibr16-0333102418779543 bibr4-0333102418779543 bibr11-0333102418779543 bibr20-0333102418779543 bibr22-0333102418779543 |
| References_xml | – volume: 55 start-page: S103 year: 2015 end-page: S122 article-title: Episodic and chronic migraine headache: Breaking down barriers to optimal treatment and prevention publication-title: Headache – volume: 158 start-page: 543 year: 2017 end-page: 559 article-title: The role of calcitonin gene-related peptide in peripheral and central pain mechanisms including migraine publication-title: Pain – article-title: Evaluation of galcanezumab for the prevention of episodic migraine: Results from the EVOLVE-1 study, a randomized phase 3 placebo-controlled clinical trial publication-title: JAMA Neurol – volume: 12 start-page: 541 year: 2012 end-page: 549 article-title: Adherence with migraine prophylaxis in clinical practice publication-title: Pain Pract – volume: 9 start-page: 285 year: 2010 end-page: 298 article-title: Current practice and future directions in the prevention and acute management of migraine publication-title: Lancet Neurol – volume: 47 start-page: 355 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Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention.
Methods
A global,... Introduction Galcanezumab is a humanized monoclonal antibody binding calcitonin gene-related peptide, used for migraine prevention. Methods A global,... |
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