Eptinezumab in episodic migraine: A randomized, double-blind, placebo-controlled study (PROMISE-1)

Area of Science:

• Neurology
• Pharmacology

Background:

• Episodic migraine is a debilitating neurological condition.
• Calcitonin gene-related peptide (CGRP) plays a crucial role in migraine pathophysiology.
• Current preventive treatments have limitations, necessitating novel therapeutic approaches.

Purpose of the Study:

• To evaluate the efficacy and safety of eptinezumab, a humanized anti-CGRP monoclonal antibody, for preventing episodic migraine.
• To assess the impact of eptinezumab on monthly migraine days (MMDs) and overall safety in a large patient cohort.

Main Methods:

• The PROMISE-1 study was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial.
• Adults with episodic migraine received intravenous eptinezumab (30mg, 100mg, or 300mg) or placebo every 12 weeks.
• The primary endpoint was the change in MMDs from baseline over the initial 12 weeks.

Main Results:

• Eptinezumab at 100mg and 300mg significantly reduced MMDs compared to placebo (p<0.0182 and p<0.0001, respectively).
• Mean reduction in MMDs from baseline was -3.9 for 100mg and -4.3 for 300mg eptinezumab.
• Adverse events were comparable to placebo, with upper respiratory tract infections and fatigue being the most common reported events.

Conclusions:

• Eptinezumab (100mg and 300mg) is effective in reducing migraine frequency for episodic migraine prevention.
• The drug was well-tolerated, exhibiting an acceptable safety profile in the studied adult population.
• Eptinezumab represents a promising new therapeutic option for the preventive treatment of episodic migraine.