High completion rates and sustained safety and tolerability were reported from an open access programme for galcanezumab in patients who completed the 3-month double-blind and 9-month open-label phases of the Phase III REGAIN trial (NCT02614261).
Patients entered the three year continuous access programme for galcanezumab approximately five to 13 months after their last study dose. Of 29 patients who entered the programme, 25 (86.2%) patients completed treatment, with a maximum exposure duration to galcanezumab of approximately 41 months. Eighteen (62.1%) reported ≥1 treatment emergent adverse event, most frequently (n=2, 7% each) COVID-19, cough, gastritis, headache, nausea, oropharyngeal pain, pruritus, and urticaria. Six (20.7%) participants reported serious adverse events, though none were considered related to treatment by the investigator. There were no discontinuations due to adverse events.
Reference
Mosek A, Li LQ, Hsu H-A et al. Long-term Treatment with Galcanezumab in 29 Patients with Chronic Migraine: Results from the 3-year Continued Access Program of the REGAIN Study. Presented at AAN2022 Annual Meeting, Seattle, USA, 2-7 April 2022
