Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines

Joshua M. Cohen, David William Dodick, Ronghua Yang, Lawrence C. Newman, Thomas Li, Ernesto Aycardi, Marcelo E. Bigal

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy. In two previous phase 2 studies, fremanezumab administered once every 28 days for 12 weeks was found to be effective and safe as a preventive treatment for patients suffering from episodic migraine (EM) and chronic migraine (CM). Objective: To evaluate the efficacy and safety of fremanezumab as an add-on preventive therapy in individuals with EM and CM who are on stable doses of preventive migraine medications. Methods: Two randomized placebo-controlled studies tested once-monthly subcutaneous injections of various dosing regimens of fremanezumab versus placebo in EM and CM. Headache information was captured daily using an electronic headache diary. For these post hoc analyses, data were pooled from patients who were on stable preventive medications and taking fremanezumab doses of 225 mg or 675/225 mg, or placebo. Results: The sample consisted of 133 patients, (67 fremanezumab and 66 placebo). Total reduction in migraine days for the duration of the study was 12.4 for fremanezumab and 7.4 for placebo (P=.0321). There were also decreases in moderate/severe headache days (12.5 vs 7.1, P=.0058), and days using acute medication for headaches relative to placebo (11.6 vs 7.5, P=.0414). Treatment emergent adverse events were generally mild and transient, and no serious adverse events were considered to be treatment-related by the site investigators. Conclusions: The findings from these post hoc analyses suggest that fremanezumab is a safe and effective add-on treatment for migraine patients being concomitantly treated with other migraine preventive medications. Trials are registered at Clinicaltrials.gov NCT02025556 and NCT02021773.

Original languageEnglish (US)
JournalHeadache
DOIs
StateAccepted/In press - 2017

Fingerprint

Preventive Medicine
Migraine Disorders
Placebos
Headache
Therapeutics
Calcitonin Gene-Related Peptide
Subcutaneous Injections
Monoclonal Antibodies
Research Personnel

Keywords

  • Calcitonin-gene-related peptide
  • Fremanezumab
  • Migraine
  • Migraine preventive medication
  • TEV-48125

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. / Cohen, Joshua M.; Dodick, David William; Yang, Ronghua; Newman, Lawrence C.; Li, Thomas; Aycardi, Ernesto; Bigal, Marcelo E.

In: Headache, 2017.

Research output: Contribution to journalArticle

Cohen, Joshua M. ; Dodick, David William ; Yang, Ronghua ; Newman, Lawrence C. ; Li, Thomas ; Aycardi, Ernesto ; Bigal, Marcelo E. / Fremanezumab as Add-On Treatment for Patients Treated With Other Migraine Preventive Medicines. In: Headache. 2017.
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abstract = "Background: Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy. In two previous phase 2 studies, fremanezumab administered once every 28 days for 12 weeks was found to be effective and safe as a preventive treatment for patients suffering from episodic migraine (EM) and chronic migraine (CM). Objective: To evaluate the efficacy and safety of fremanezumab as an add-on preventive therapy in individuals with EM and CM who are on stable doses of preventive migraine medications. Methods: Two randomized placebo-controlled studies tested once-monthly subcutaneous injections of various dosing regimens of fremanezumab versus placebo in EM and CM. Headache information was captured daily using an electronic headache diary. For these post hoc analyses, data were pooled from patients who were on stable preventive medications and taking fremanezumab doses of 225 mg or 675/225 mg, or placebo. Results: The sample consisted of 133 patients, (67 fremanezumab and 66 placebo). Total reduction in migraine days for the duration of the study was 12.4 for fremanezumab and 7.4 for placebo (P=.0321). There were also decreases in moderate/severe headache days (12.5 vs 7.1, P=.0058), and days using acute medication for headaches relative to placebo (11.6 vs 7.5, P=.0414). Treatment emergent adverse events were generally mild and transient, and no serious adverse events were considered to be treatment-related by the site investigators. Conclusions: The findings from these post hoc analyses suggest that fremanezumab is a safe and effective add-on treatment for migraine patients being concomitantly treated with other migraine preventive medications. Trials are registered at Clinicaltrials.gov NCT02025556 and NCT02021773.",
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