Neurol Clin Pract. 2026 Apr;16(2):e200565. doi: 10.1212/CPJ.0000000000200565. Epub 2026 Feb 2.
ABSTRACT
BACKGROUND AND OBJECTIVES: Migraine is a significant disabling neurologic headache disorder globally. Evaluating patient-related outcomes (PROs) is necessary to assess the impact of therapeutic interventions in preventive therapy. An exploratory analysis of data from the EMPOwER study examined the effect of erenumab on PROs in patients with episodic migraine (EM) in regions underrepresented in the pivotal Phase 3 trials of erenumab, specifically Asia, the Middle East, and Latin America.
METHODS: Patients (N = 900) were randomized (2:3:3) to receive monthly subcutaneous injections of erenumab 140 mg, erenumab 70 mg, or placebo. Adjusted mean changes from baseline in the Headache Impact Test (HIT-6), Migraine Physical Function Impact Diary (MPFID), modified Migraine Disability Assessment (mMIDAS), and EuroQoL 5-dimension 5-level scale (EQ-5D-5L) scores were assessed during the double-blind treatment phase of 3 months.
RESULTS: A statistically significant reduction from baseline in the HIT-6 total score was observed for erenumab 140 mg (-9.34, p < 0.001) and 70 mg (-8.39, p = 0.004) vs placebo (-6.62) at Month 3. Improvement in MPFID scores was also greater in the erenumab groups vs the placebo group (Everyday Activity: 140 mg, -5.61 [p = 0.002]; 70 mg, -4.94 [p = 0.011]; placebo, -3.19; Physical Impairment: 140 mg, -4.27 [p = 0.014]; 70 mg, -3.95 [p = 0.021]; placebo, -2.31) at Month 3. Similar findings were observed for mMIDAS scores (140 mg -8.99 [p < 0.001], 70 mg -8.11 [p = 0.011] vs placebo [-6.59]) and the EQ-5D-5L quality-of-life visual analog scale scores (140 mg 8.13 [p = 0.017], 70 mg 7.08 [p = 0.088] vs placebo [5.22]), although no meaningful between-group difference was noted for index values.
DISCUSSION: Erenumab showed favorable effects on PROs when compared with placebo in patients with EM. These results enhance the evidence for erenumab as an effective preventive therapy for patients with EM.
TRIAL REGISTRATION INFORMATION: Clinicaltrials.gov/study/NCT03333109.
PMID:41641373 | PMC:PMC12867334 | DOI:10.1212/CPJ.0000000000200565
