Long-term efficacy and safety of erenumab

Over 52 weeks, erenumab provided sustained efficacy in prevention of episodic migraine in patients enrolled in the phase 3 STRIVE study [1]. The safety profile was comparable to that observed in prior studies, with no new relevant safety findings.

In the 24-week double-blind treatment phase of the STRIVE study, 955 participants were randomised to placebo, erenumab 70 mg, or erenumab 140 mg monthly. In the dose-blinded active treatment phase, the 845 patients who remained in the study were rerandomised to erenumab 70 mg or 140 mg from week 24 to 52. At week 52, the change in number of monthly migraine days in the erenumab 70 mg and 140 mg groups during active treatment phase was –4.2 and –4.6, respectively, compared to study baseline; and –1.1 and –1.8 compared to active treatment phase baseline. Improvements were also seen in monthly acute migraine-specific medication treatment days. After 52 weeks, 61% of patients on 70 mg and 65% of patients on 140 mg achieved a ≥50% reduction in monthly migraine days; 38.5% and 40.8% achieved a ≥75% reduction; and 20% and 21% achieved 100% reduction.

Another study showed efficacy of erenumab in chronic migraine patients with medication overuse who had previously failed preventive treatment [2]. This was a post-hoc analysis for the medication overuse subgroup (n=349/667, 52.3%) of a pivotal placebo-controlled, double-blind, randomised study of erenumab in chronic migraine patients [3]. Changes in monthly migraine days were significantly greater for this group compared with placebo: -5.5 (70 mg) and -7.4 (140 mg) vs -2.9 days (P<0.001). The proportion of medication overuse patients with at least a 50% reduction in monthly migraine days was also greater for erenumab: 31.9% and 41.7% vs 15.2%.

In the 52-week, open-label extension of the same parent study [3], two-thirds of 469 patients converted and/or sustained conversion from chronic migraine to episodic migraine, with higher conversion rates at 140 mg [4]. Conversion to episodic migraine is clinically meaningful, which can be deduced by greater monthly migraine days reductions and higher ≥50% response rates. Most conversions had already taken place at 12 weeks. The overall proportion of converters was 64% at 12 weeks, and 72% at 52 weeks.

1. Chou DE, et al. AA2019, S38.005
2. Dodick D, et al. AAN 2019, S38.002.
3. Tepper S, et al. Lancet Neurol. 2017;16(6):425-34.
4. Lipton R, et al. AAN 2019, S17.008.



Posted on 30 July 201915 March 2021