Abstract Details

Title Long-term Treatment with Galcanezumab in 29 Patients with Chronic Migraine: Results from the 3-year Continued Access Program of the REGAIN Study

Topic Headache

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 197

Objective To evaluate the long-term safety of galcanezumab, a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide, for the treatment of chronic migraine as part of a continuous access program in Israel.

Background Results from the 3-month double-blind and 9-month open-label phases of the Phase III REGAIN (NCT02614261) clinical trial demonstrated that galcanezumab was efficacious, safe, and well-tolerated for the preventive treatment of chronic migraine.

Design/Methods Eligible patients were 18-65 years of age with chronic migraine who completed the REGAIN study, including the 9-month open-label treatment period and 4-month post-treatment washout. Patients had a gap of approximately 5 to 13 months from their last study dose before starting the 3-year continuous access program. All patients received open-label galcanezumab at 120 mg/month (one injection) or 240 mg/month (two 120-mg injections), at the investigator’s discretion. Investigators were permitted to reinitiate treatment with a 240-mg loading dose, if warranted. Site personnel and patients remained blinded to previous treatment assignments. Outcomes measured for this long-term safety evaluation were the incidence of treatment-emergent adverse events (TEAEs), serious AEs (SAEs), and discontinuation due to AEs (DCAEs).

Results

Twenty-nine participants (83 patient-years) who completed the REGAIN trial were included in this analysis; 25 (86.2%) patients completed the continuous access program. Maximum exposure duration to galcanezumab was approximately 41 months. A total of 18 (62.1%) participants reported ≥1 TEAE. The most frequently reported TEAEs during the continuous access program (n=2, 7% each) were COVID-19, cough, gastritis, headache, nausea, oropharyngeal pain, pruritus, and urticaria. Six (20.7%) participants reported SAEs; none were considered related to treatment by the investigator. No DCAEs occurred during the program.

Conclusions There was a high completion rate after up to 3 years of treatment. In this small continuous access program, galcanezumab demonstrated a favorable safety and tolerability profile consistent with other long-term, preventive treatment studies of migraine.

Authors/Disclosures
Lily Li PRESENTER	Lily Li has received personal compensation for serving as an employee of Eli Lilly and Company. Lily Li has stock in Eli Lilly and Company.
Amnon Mosek	No disclosure on file
	No disclosure on file
	No disclosure on file
Gabriel Vainstein, MD (Maccabi Healthcare Services)	No disclosure on file

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