A long-term open-label safety study of galcanezumab in Japanese patients with migraine. Issue 6 (3rd June 2021)

• Record Type: Journal Article
• Authors: Hirata, Koichi; Takeshima, Takao; Sakai, Fumihiko; Tatsuoka, Yoshihisa; Suzuki, Norihiro; Igarashi, Hisaka; Nakamura, Tomomi; Ozeki, Akichika; Yamazaki, Hiroyoshi; Skljarevski, Vladimir
• Is Part Of: Expert opinion on drug safety. Volume 20:Issue 6(2021)
• Page Start: 721
• Page End: 733
• Publication Date: 2021-06-03
• Subjects: MeSH: Calcitonin gene-related peptide -- galcanezumab -- japan -- migraine -- safety -- non-MeSH: Open-label study; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2021.1866536
• Languages: English
• ISSNs: 1474-0338

Abstract

ABSTRACT: Background: Because of the burden of migraine in Japan, there is a need for safe and effective preventive treatments. This study assessed the long-term safety and tolerability of galcanezumab in Japanese patients with episodic (EM) or chronic (CM) migraine. Research design and methods: In this 12-month open-label study, adult patients with EM who previously completed a 6-month, double-blind, placebo-controlled trial were newly randomized to either galcanezumab dose from placebo or continued their assigned galcanezumab doses (all: 120 mg, n = 120; 240 mg, n = 126). Newly enrolled patients with CM were randomized to 120-mg (n = 32) or 240-mg (n = 33) galcanezumab. The primary outcome was long-term safety and tolerability. Results: The incidence of TEAEs was similar between treatment groups. Nasopharyngitis was the most common TEAE, followed by injection site reactions. The discontinuation rate was low (EM = 9.3%; CM = 15.4%) and no deaths were reported. Patients with EM who received galcanezumab in the placebo-controlled trial had sustained efficacy. Both doses reduced the number of migraine headache days in patients with CM. Conclusions: Long-term treatment with 120-mg or 240-mg galcanezumab was safe and effective in Japanese patients with EM or CM. Trial registration: https://clinicaltrials.gov, identifier: NCT02959190.