Erenumab Monotherapy Shows Sustained Long-Term Efficacy in Patients With Episodic Migraine

In patients with episodic migraine who did not successfully respond to 2 to 4 prior preventive treatments, erenumab (Aimovig; Amgen, Novartis) was found to have a sustained efficacy as a monotherapy treatment during a period of up to 64 weeks, according to results from the LIBERTY study.

Additionally, the investigators observed that the safety of erenumab was consistent with the safety profile found during previous clinical trials.

During the study, investigators enrolled 240 patients with episodic migraine who had previously completed the double-blind treatment trial phase (DBTP). In DBTP, patients received either a placebo or erenumab at 140 mg as a monotherapy administered through subcutaneous injections every 4 weeks.

In the current open-label extension phase (OLEP) of the LIBERTY study, the investigators assigned patients at random to the once-monthly subcutaneous injections of erenumab monotherapy dosed at 140 mg over a period of 3 years. The investigators also allowed patients who were in the placebo arm of the DBTP to move to erenumab during the OLEP.

In total, the week 52 visit in the OLEP was completed by 85% patients, with 36 patients discontinuing treatment in the OLEP either before or at week 64. The reasons patients discontinued the treatment included lack of efficacy (7.9%), subject or guardian decision (4.6%), and the occurrence of adverse events (1.7%).

Among patients who continued erenumab during the trial, the 50% responder rate increased from 29.9% during weeks 9 through 12 and up to 44.3% during weeks 61 through 64. In patients who initiated erenumab in the OLEP, the 50% responder rate was greater in the OLEP at 50.0% during weeks 61 through 64 than during DBTP at 14.2% during weeks 9 through 12, compared with the results from patients in the continuous erenumab arm.

Among the overall population, the 50% responder rate in the OLEP increased from weeks 13 through 16 up to weeks 37 through 40, and then remained stable during weeks 61 through 64.

Additionally, patients who were treated with erenumab in the DBTP demonstrated sustained efficacy across all measured efficacy outcomes, whereas those who initiated erenumab in the OLEP demonstrated ongoing improvement starting at week 13 and thereafter.

Overall, the investigators found that approximately 80.8% of patients experienced adverse events (AEs), whereas serious AEs occurred in 6.7% of patients; however, no deaths occurred among this patient population.

REFERENCE

Goadsby PJ, Reuter U, Lanteri-Minet M, et al. Long-term Efficacy and Safety of Erenumab: Results From 64 Weeks of the LIBERTY Study. Neurology. April 28, 2021. doi: 10.1212/WNL.0000000000012029.