Data Highlight Long-Term Efficacy of Erenumab for Episodic Migraine

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%).

Analyses revealed:

• Average (standard error) MMD at DBTP baseline was 8.3
• At week 52, average changes from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were —4.2 (0.2)/–1.1(0.2) (70 mg) and −4.6 (0.2)/−1.8 (0.2) (140mg), irrespective of treatment during the DBTP
• For patients reducing dosage from 140 mg (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was −0.1 (0.3), and for those increasing from 70 mg (DBTP) to 140 mg (ATP) was change was measured as −1.8 (0.3)
• At week 52, 61.0%, 38.5% and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8% and 21.2% on erenumab 140 mg, achieved at least 50%, at least 75% and 100% reduction in MMD from DBTP baseline, respectively
• Among erenumab-treated patients in DBTP who showed at least 50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses of at least 50% during the last 3 months of ATP
• Treatment-emergent adverse events (TEAEs) during the ATP were reported in 241 (57.2%) and 233 (55.0%) patients in the erenumab 70 mg and the erenumab 140 mg groups, respectively

According to authors, the “findings were lower than the exposure-adjusted subject incidence rates for TEAEs for patients receiving either placebo (256.2 per 100 subject-years) or erenumab 70 mg (215.0 per 100 subject-years) or 140 mg (208.5 per 100 subject-years) during the DBTP.”

The most common adverse events reported during the ATP were viral upper respiratory tract infection and upper respiratory tract infection. Both infections were also observed in the DBTP.

Overall, safety of erenumab in the ATP was similar to the DBTP. In addition, 86% of patients who responded at the end of the DBTP continued to respond during the ATP, whereas 36% of patients who did not respond during the DBTP did respond in the ATP.

Future studies can confirm whether sustained treatment benefits and good tolerability observed with erenumab lead to improved long-term treatment adherence and outcomes in individuals with episodic migraine.

“These data show that the efficacy of erenumab in both dose groups in patients with episodic migraine is sustained through 1 year of treatment, with a favorable safety and tolerability profile,” authors conclude.

Reference

Goadsby PJ, Reuter U, Y Hallström, et al. One-year sustained efficacy of erenumab in episodic migraine: results of the STRIVE study. Neurology. Published online July 7, 2020. doi:10.1212/WNL.0000000000010019