ArticleEuropean journal of neurology2026
MIDAS and HIT-6 Questionnaires Versus Headache Diaries for Monitoring Treatment Response to Erenumab in Migraine: A REFORM Study.
Article in European journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04603976 (Registry for Migraine - Clinical Core), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Registry for Migraine - Clinical Core
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Authors and funding
6 authors.
Funding
Abstract
backgroundHeadache 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).
methodsThis 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.
resultsAmong 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.
conclusionsAlthough 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 registrationNCT04603976.
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