Galcanezumab Supports Transition From Chronic to Episodic Migraine

Among patients with chronic migraine, treatment with galcanezumab may be effective for the transition to episodic migraine over a 12-month period, according to study findings published in The Journal of Headache and Pain.

Chronic migraine, defined as 15 or more headache days per month, is a debilitating neurologic condition associated with severe disability, high health care costs, and frequent medication overuse. While preventive treatments exist, many have limited efficacy, poor adherence, and high discontinuation rates. Galcanezumab, a monoclonal antibody targeting calcitonin gene-related peptide, is already approved for migraine prevention. Given that episodic migraine is associated with a lower disease burden, transitioning patients from chronic to episodic migraine represents a valuable clinical outcome.

Researchers conducted a post hoc analysis of a phase 3, double-blind, placebo-controlled study (REGAIN trial; ClinicalTrials.gov Identifier: NCT02614261) to evaluate the proportion of patients who shifted from chronic to episodic migraine when treated with galcanezumab vs placebo. A total of 1113 adult patients (age range, 18-65 years) were randomly assigned 2:1:1 to receive placebo (N=558), galcanezumab 120 mg with a 240-mg loading dose (N=278), or galcanezumab 240 mg (N=277) over a 3-month double-blind period, followed by a 9-month open-label extension (OLE).

In the OLE phase, 1022 patients continued treatment, with 825 (80.7%) completing the full study. Patients were a mean (SD) age of 41.0 (12.1) years, 85.0% were women, and 63.8% had acute headache medication overuse at baseline. During the OLE phase, 64.3% of patients received 2 injections (240 mg) at the first flexible dosing visit, with this proportion increasing to 75.8% by visit 14. Discontinuation rates remained low, with 4.5% withdrawing due to adverse events and 3.9% due to lack of efficacy.

Galcanezumab significantly reduced migraine frequency. At 3 months, 55.9% of patients who received galcanezumab 120 mg and 53.0% of the pooled galcanezumab group transitioned from chronic to episodic migraine, compared with  42.3% of those who received placebo (P <.01). These improvements were sustained for at least 3 months in 31.5% of treated patients vs 19.8% of those who received placebo (P <.001).

Over 12 months, 63.5% to 66.2% of patients achieved a sustained shift to episodic migraine, with 43.7% to 45.0% progressing to low-frequency episodic migraine (LFEM) and 19.4% to 23.4% to very low-frequency episodic migraine (VLFEM). Notably, 86.3% of patients on a consistent 120 mg regimen transitioned to episodic migraine for at least 3 months, further supporting the long-term efficacy of galcanezumab in migraine management.

Limitations of the study include the absence of a placebo control during the OLE phase, potential selection bias in dose adjustments, and the lack of standardized definitions for LFEM and VLFEM in migraine classification.

“Results from this 12-month phase 3 study suggest that galcanezumab for the preventive treatment of CM [chronic migraine] may lead to substantial proportions of patients shifting to EM [episodic migraine] frequency for ≥ 3 consecutive months,” the researchers concluded. They added, “Over a longer term period of 12 months, treatment with galcanezumab may lead to even larger proportions shifting to EM frequency.”

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Clinical Pain Advisor