One-year sustained efficacy of erenumab in episodic migraine: Results of the STRIVE study

Abstract

Objective: To assess efficacy and tolerability of 1-year erenumab treatment in patients with episodic migraine.

Methods: Patients were randomized (n = 955; 1:1:1) during the 24-week double-blind treatment phase (DBTP) to monthly subcutaneous placebo or erenumab 70 or 140 mg. At week 24, 845 patients were rerandomized (1:1) to erenumab 70 or 140 mg during the 28-week dose-blinded active-treatment phase (ATP). Monthly migraine days (MMD), achieving ≥50%, ≥75%, and 100% reduction in MMD, and safety/tolerability were assessed.

Results: Mean MMD at DBTP baseline was 8.3. At week 52, mean changes (SE) from pre-DBTP baseline/week 24 (pre-ATP baseline) in MMD were -4.2 (0.2)/-1.1 (0.2) (70 mg) and -4.6 (0.2)/-1.8 (0.2) (140 mg) irrespective of treatment during the DBTP. For patients reducing dose from 140 (DBTP) to 70 mg (ATP), change in MMD from week 24 to 52 was -0.1 (0.3), and for those increasing from 70 (DBTP) to 140 mg (ATP), -1.8 (0.3). At week 52, 61.0%, 38.5%, and 19.8% of patients on erenumab 70 mg, and 64.9%, 40.8%, and 21.2% on erenumab 140 mg, achieved ≥50%, ≥75%, and 100% reduction in MMD from DBTP baseline, respectively. Among erenumab-treated patients in DBTP who showed ≥50% reduction in MMD during the last 3 months of DBTP and completed ATP, 86% showed sustained responses at ≥50% during the last 3 months of ATP. Safety of erenumab in ATP was similar to DBTP; exposure-adjusted incidence rates of adverse events were similar for either dose.

Conclusion: Over 52 weeks, erenumab provided sustained efficacy in episodic migraine; the safety profiles were similar between erenumab dose groups in the presence of dose blinding.

Clinicaltrialsgov identifier: NCT02456740.

Classification of evidence: Class II evidence that 52 weeks of treatment with erenumab 70 and 140 mg subcutaneously monthly results in sustained reductions in monthly migraine days and similar dose tolerability for patients with episodic migraine.

Figure 1. Study design

The active treatment phase (ATP) treatment group was stratified by double-blind treatment phase (DBTP) treatment assignment. All erenumab 70 mg in the ATP comprised patients with the following DBTP treatment assignments: placebo (n = 138), erenumab 70 mg (n = 140), erenumab 140 mg (n = 143). All erenumab 140 mg in the ATP comprised patients with the following DBTP treatment assignments: placebo (n = 140), erenumab 70 mg (n = 140), erenumab 140 mg (n = 144). Pre-DBTP (study) baseline: the monthly measurement obtained before the first dose of erenumab or placebo in the DBTP; pre-ATP baseline: the last monthly measurement obtained at the end of the DBTP (in most cases at week 24 before the first dose of erenumab in the ATP). QM = once monthly; SC = subcutaneous; STRIVE = Study to Evaluate the Efficacy and Safety of Erenumab in Migraine Prevention.

Figure 2. Mean change in monthly migraine days (MMDs) from pre–double-blind treatment phase (DBTP) and pre–active treatment phase (ATP) baselines

Mean change (SE) in MMDs from the (A) pre-DBTP baseline every 4 weeks during weeks 0–52; (B) pre-DBTP (study) baseline at week 52; and (C) pre-ATP baseline at week 52. MMDs = monthly migraine days; PBO = placebo; SE = standard error.

Figure 3. Proportion of patients achieving ≥50%, ≥75%, and 100% reduction in monthly migraine days (MMDs) from pre–double-blind treatment phase (DBTP) baseline

Proportion of patients achieving (A) ≥50%; (B) ≥75%; and (C) 100% reduction in MMDs from the pre-DBTP (study) baseline to week 52.