In patients with episodic migraine, erenumab provided sustained efficacy for the condition over the course of 1 year, according to new results from a study to evaluate the efficacy and safety of erenumab in migraine prevention (STRIVE), published in Neurology.
Historically, adherence to available preventive therapies for episodic migraine has been lacking, as patients commonly report insufficient efficacy or poor tolerability as reasons to discontinue treatment.
Erenumab, which was approved by the FDA in 2018, is a calcitonin gene-related peptide (CGRP) inhibitor. The once-monthly self-injected treatment works by blocking the CGRP receptor, which is believed to play a crucial role in migraine. The treatment can be injected as a 70 mg or 140 mg dose in adults with migraine.
“For any new drug and mechanism of action, it is important to provide longer-term safety data and evidence for sustained efficacy beyond that observed during the relatively short placebo-controlled study period,” authors write.
Following results from the 24-week double-blind treatment phase (DBTP), the 28-week dose-blinded active treatment phase (ATP) assessed the efficacy, tolerability, and safety of 70 mg and 140 mg of erenumab after 1 year. Sustained reduction in monthly migraine days (MMD) and any improvement in patient-reported outcomes were analyzed.
Eight hundred and forty-five patients (88.5% of the original DBTP cohort) were re-randomized to receive either erenumab 70 mg (n = 421) or erenumab 140 mg (n = 424) each month in a dose-blinded fashion. “Re-randomization was stratified as per the treatment groups (placebo, erenumab 70 mg, or erenumab 140 mg) assigned during the DBTP,” authors noted. However, 762 individuals completed the whole ATP.
Researchers reported change from the pre-DBTP baseline and change from the pre-ATP baseline, although change from the pre-ATP baseline was the primary analytical approach for the ATP.
All participants were aged 18 to 65 and had a history of episodic migraine with or without aura for at least 1 year before screening. Episodic migraine was defined as “having 4 to 14 migraine days per month and <15 headache days per month across the 3 months prior to screening and during the 1-month pre-DBTP baseline period.”
Average participant age was around 42 years, and the majority were female (84.4%) and white (90.2%).