Real-Word Evidence Outlines Efficacy of Erenumab for Highly Therapy-Refractory Migraine

A study based on real-world data collected from the West German Headache Center at the University Hospital Essen, Germany, concluded erenumab appears to be a promising treatment option for patients with highly therapy-refractory migraine.

Erenumab, which was approved by the FDA in 2018, is a calcitonin gene-related peptide (CGRP) inhibitor administered via self-injection once a month. The treatment works by blocking the CGRP receptor, which is believed to play a crucial role in migraine. Erenumab can be injected as a 70- or 140 mg dose in adults with migraine.

In the past, clinical trials on CGRP inhibitors were only performed in migraineurs who had failed up to 4 prophylactic medications. “Although there are indications of good effectiveness under real-world conditions, data on highly therapy-refractory patients that had failed more than 4 prophylactic treatments are missing, yet,” the authors said.

They analyzed routine clinical data of patients with episodic (EM) and chronic migraine (CM) between November 2018 and December 2019 who received 70 mg of erenumab for 3 months (n = 100). The majority of patients included were female (82%), 26% suffered from EM, and 74% suffered from CM. Forty-nine patients with CM also reported additional medication overuse headache (MOH).

All participants completed a paper-based headache diary, and most patients answered questionnaires regarding different aspects of migraine attacks including intensity, duration, effect of acute therapy, effect on aura, need for rest, dizziness, nausea, phono-and photophobia, and therapy satisfaction.

At the time of the study, “all treated patients had tried at least 5 (when EM) and 6 (when CM) approved prophylactic drugs previously without sufficient treatment effects, had discontinued those due to side effects, or were not eligible for intake due to contraindication,” the researchers said.

Analyses revealed that after 3 months of erenumab therapy:

• 57.7% (n = 15) of patients with EM and 41.9% (n = 31) with CM had at least a 50% reduction in monthly migraine days (MMD)
• 53% (n = 39) of patients with CM returned from chronic to episodic course of migraine
• 46.9% (n = 23) of patients with MOH were no longer suffering from MOH
• Subjective improvement of migraine intensity and duration was reported by 70.5% (n = 67) and 58.9% (n = 53) of the patients, respectively
• Subjective treatment effects on migraine-associated vegetative symptoms were small while the efficacy of acute medication was largely unchanged with therapy
• Self-reported general satisfaction with therapy was high (very satisfactory/satisfactory, 61.3% [n = 57]; moderately satisfactory, 20.4% [n = 19]; unsatisfactory/very unsatisfactory, 18.3% [n = 17])
• 42% of patients reported adverse effects, mainly digestive problems or constipation (23.8%, n = 10), injection-site skin symptoms or itching (23.8%, n = 10), fatigue or a feeling of exhaustion (16.7%, n = 7), and insomnia (9.5%, n = 4)

“Efficacy of erenumab in highly therapy-refractory patients is comparable to results from clinical trials of patients that had failed fewer prophylactic medications prior treatment,” the authors write. However, further data will show the extent to which the effect remains stable during long-term treatment.

Data included in the study are mainly based on subjective reports from patients, marking a limitation in the study.

Reference

Scheffler A, Messel O, Wurthmann S, et al. Erenumab in highly therapy-refractory migraine patients: first German real-world evidence. J Headache Pain. 2020;21(1):84. doi:10.1186/s10194-020-01151-0