Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study

Marc Ehrlich, Christian Hentschke, Christian Sieder, Monika Maier-Peuschel, Uwe Reuter, Marc Ehrlich, Christian Hentschke, Christian Sieder, Monika Maier-Peuschel, Uwe Reuter

Abstract

Objective: HER-MES was the first head-to-head, phase 4 trial to assess the tolerability and effectiveness of erenumab against standard of care treatment (topiramate). This post hoc analysis compared the efficacy of erenumab with topiramate in patients who completed the trial on study medication.

Methods: Post hoc sensitivity analysis was performed using the full analysis set. Outcomes assessed included the proportion of patients with a ≥50% reduction in monthly migraine days (MMD) from baseline (50% responder rate), over the last 3 months (months 4, 5, and 6) of the double-blind treatment phase (DBTP), the 50% responder rate during the first month of the DBTP, and change from baseline in MMD during the DBTP. Multiple imputation was done for efficacy values of patients who discontinued study treatment.

Results: Patients (N = 777) were randomly assigned (1:1) to either 70 or 140 mg/month erenumab (N = 389) or 50-100 mg/day topiramate (N = 388). Of these, 334 patients (85.9%) receiving erenumab, and 231 patients (59.5%) receiving topiramate completed the DBTP on study medication. Patients on study medication until the end of the DBTP received a mean dose of 119 mg/month for erenumab and 92 mg/day for topiramate. At month 1, a significantly greater proportion of patients receiving erenumab (39.2%) reported ≥50% reduction in MMD from baseline compared with those receiving topiramate (24.0%; p < 0.001). In the last 3 months, a significantly larger proportion of patients receiving erenumab (60.3%) achieved ≥50% reduction in MMD from baseline compared with those receiving topiramate (43.3%; p < 0.001). Patients receiving erenumab demonstrated significantly greater reductions in MMD during the last 3 months from baseline versus those receiving topiramate (- 6.13 vs - 4.90; 95% CI: - 1.87 to - 0.61; p < 0.001).

Conclusions: This post hoc analysis demonstrated significantly superior efficacy of erenumab versus topiramate in achieving a ≥50% reduction in MMD with an early onset of efficacy.

Trial registration: ClinicalTrials.gov NCT03828539 .

Keywords: Calcitonin gene-related peptide; Efficacy; Erenumab; Migraine; Preventive; Standard of care; Topiramate.

Conflict of interest statement

Uwe Reuter reports grants, personal fees and other from Novartis, and personal fees and other from Amgen during the conduct of the study. He reports personal fees and other from AbbVie; grants, personal fees and other from Allergan; other from Alder; personal fees and other from Eli Lilly; personal fees from Lundbeck; personal fees from Pfizer; personal fees from Medscape and StreaMedUP; grants, personal fees and other from Novartis; and personal fees from Teva Pharmaceuticals outside the submitted work.

Marc Ehrlich, Monika Maier-Peuschel, Christian Sieder, and Christian Hentschke are employees of, and hold stocks in Novartis.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Treatment assignment, reasons for discontinuation and patients included in post hoc analysis
Fig. 2
Fig. 2
Proportion of patients who achieved at least a 50% reduction in MMD (post hoc analysis)
Fig. 3
Fig. 3
Change from baseline in MMD during the 24-week DBTP by month

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