Long-term Effectiveness and Safety of Erenumab in patients with Migraine: a Systematic Review and Single-Arm Meta-analysis

Abstract text (incl. figure legends and references)

Background: Several studies on use of erenumab for migraine treatment have been published over the last years. This study aims to estimate the safety and effectiveness of erenumab on the long-term basis (established as ≥ 1 year of exposure).
Methods: PubMed, Embase and Cochrane were systematically searched randomized clinical trials (RCTs) phase extensions and real-world studies through June 2022. Risk of bias was assessed using the Newcastle-Ottawa Scale.
Results: 14 studies comprising 3,574 patients met the inclusion criteria. Total follow-up period ranged from 48 up to 268 weeks (i.e., 1 year to 5.6 years). The pooled estimate rates for all adverse events (AEs) were 63% (CI: 46-78% - see Figure 1A); for serious AEs, 3% (95% CI: 1-7% - see Figure 1B); and for AEs leading to discontinuation of erenumab, 3% (95% CI: 2-5% - see Figure 1C). AEs corresponded to the minority (15.8%) of all reasons to discontinuation from reported data. Reduction in monthly migraine days (MMDs) was -6.98 (95% CI: -8,90; -5.05 - see Figure 2A) and in migraine specific medication days (MSMDs), -6.09 (95% CI: -9.43; -2.75 - see Figure 2B). More than half (57%; 95% CI: 51-63% - see Figure 3A) and around one-third (35%; 95% CI: 28-42% - see Figure 3B) of patients presented reductions of ≥ 50% and ≥ 75% in MMDs, respectively. Headache Impact Test-6 (HIT-6) score was decreased in -9.68 points (95% CI: -12.03; -7.34 - see Figure 2C).
Conclusions: Cumulative analysis of data revealed a consistent favorable safety profile and a sustained effectiveness of erenumab with long-term exposure in the treatment of migraine.

Figure 1 – Incidence of AEs
1(A) – All AEs
1(B) - Serious AEs
1(C) - AEs leading to discontinuation

Figure 2 – Change from baseline
2(A) – in MMDs
2 (B) - in MSMDs
2 (C) - in HIT-6

Figure 3 – Percentage reduction in MMDs
3 (A) – ≥50%
3 (B) - ≥75%