Erenumab effective for migraine regardless of aura status

In a post hoc analysis, use of the anti-CGRP* receptor monoclonal antibody erenumab led to reduced migraine frequency and AMSM** days in individuals with migraine with and without a history of aura.

Individuals with migraine with aura may respond differently to acute migraine treatments compared with those with migraine without aura. [J Headache Pain 2019;20:96] Also, CGRP apparently provokes migraine attacks without aura in patients with a history of aura. [Cephalalgia 2010;30:1179-1186] “Thus, it [is] not known whether erenumab [is] efficacious in patients with migraine with a history of aura,” said the researchers.

“Individuals with migraine with aura have an elevated vascular risk, necessitating a safety assessment of migraine preventive treatments in this patient subgroup,” they added.

This secondary analysis of four randomized trials comprised individuals who had episodic*** or chronic^# migraine (n=2,682; mean age 41.7 years, 84 percent female, mean disease duration 20.7 years). Participants were randomized to receive either ≥1 SC dose of erenumab 70 or 140 mg Q4W or placebo during the 12- or 24-week double-blind treatment phase, and erenumab 70 or 140 mg during the extension phase (open-label or dose-blinded active treatment phase) spanning 28 weeks to 5 years. [JAMA Neurol 2021;doi:10.1001/jamaneurol.2021.4678]

 

With history of aura

At week 12, among those with episodic migraine, erenumab fared better than placebo in terms of reductions in MMDs^## (least-squares mean [LSM] differences, –1.1 [70 mg] and –0.9 [140 mg]) and monthly AMSM days (LSM differences, –0.9 and −1.3), as well as the proportions of patients achieving ≥50-percent MMD reduction from baseline (44 percent and 46 percent vs 32 percent). 

A similar trend favouring erenumab 70 and 140 mg over placebo was seen among those with chronic migraine (LSM differences, –2.1 and –3.1 [MMDs] and –2.4 and −3.7 [AMSM days], and 42 percent and 46 percent vs 24 percent [≥50 percent response rates]).

 

Without history of aura

In this subset, results across all parameters evaluated were similar, be it among those with episodic (LSM differences, –1.2 and –2.5 [MMD] and –1.3 and −2.4 [AMSM days] and 37 percent and 51 percent vs 25 percent [≥50-percent response rates]) or chronic migraine (LSM differences, –2.7 and –2.1 [MMD] and –2.3 and −3.0 [AMSM days], and 38 percent and 38 percent vs 23 percent [≥50-percent response rates]). 

These findings suggest that reductions from baseline MMDs and AMSM days were greater in patients who received erenumab than those who received placebo, and more erenumab vs placebo recipients achieved ≥50-percent MMD reduction from baseline in both history of aura subgroups, the researchers noted. “[These reductions were seen] during the double-blind treatment phase and … were maintained throughout the extension phases.”

 

Safety

“Overall safety profiles were similar across treatment arms regardless of aura history,” the researchers said. These were evident in the similar incidences of adverse events (AEs) among erenumab and placebo recipients with (48 percent in both arms) and without history of aura (46 percent vs 50 percent). 

Most AEs were mild or moderate in severity. Discontinuation rates owing to an AE among erenumab recipients with vs without history of aura were low (2.3 percent vs 1.4 percent).

 

Class II evidence

However, the results may not be generalizable to ethnic minorities and individuals aged >65 years given the limited samples representing these subgroups, the researchers noted. Furthermore, there were some disparities in baseline characteristics (eg, time of erenumab exposure, higher incidence of previous medication use in patients without history of aura) and patients with history of aura were overrepresented.

“[Nonetheless,] we believe this analysis provides Class II evidence^### … as the evidence showed a reduction in MMDs and a reduction in AMSM use,” said the researchers. “Findings from this post hoc secondary analysis support the safety and efficacy of erenumab in patients with migraine with or without a history of aura.”