MIDAS and HIT-6 Questionnaires Versus Headache Diaries for Monitoring Treatment Response to Erenumab in Migraine: A REFORM Study.

BACKGROUND

Headache diaries are the gold standard for assessing preventive migraine treatments but can be burdensome. The Migraine Disability Assessment (MIDAS) and the six-item Headache Impact Test (HIT-6) offer alternatives for monitoring treatment response, though their effectiveness in identifying treatment responders is unclear relative to diary-based measures. This study evaluated how well MIDAS and HIT-6 distinguish responders from non-responders to erenumab, and aimed to determine cut-off scores that best align with a ≥ 50% reduction in monthly migraine days (MMDs).

METHODS

This prospective, open-label study enrolled adults with migraine who received 140 mg erenumab for 24 weeks. Treatment response was a ≥ 50% reduction in MMDs based on diary data. MIDAS and HIT-6 were completed at baseline, Week 12, and Week 24. Discriminative ability and optimal cut-offs were determined using receiver operating characteristic curve analysis.

RESULTS

Among 582 participants, 300 individuals (52%) achieved a ≥ 50% reduction in MMDs. MIDAS and HIT-6 demonstrated fair discriminative ability in identifying treatment responders, with area under the curve values ranging from 0.71 to 0.77. The optimal MIDAS cut-offs were either a 16-point absolute reduction (78% sensitivity, 60% specificity) or a 49% relative reduction (82% sensitivity, 64% specificity). For HIT-6, optimal thresholds included an 8-point reduction (53% sensitivity, 84% specificity) or a 12% relative reduction (54% sensitivity, 84% specificity). Sensitivity analyses using alternative response definitions confirmed the primary findings.

CONCLUSIONS

Although MIDAS and HIT-6 contribute meaningful information on treatment-related disability reduction, these retrospective tools lack sufficient precision to replace prospective headache diaries in assessing response to erenumab.

TRIAL REGISTRATION: NCT04603976.