Responder discordance between migraine frequency and patient-reported outcomes after CGRP-pathway monoclonal antibody treatment: a secondary analysis of public patient-level data
Abstract
Background: Monoclonal antibodies targeting the calcitonin gene-related peptide (CGRP) pathway are established preventive treatments for migraine. Although treatment response is often summarized by reduction in monthly migraine days (MMD), patients and clinicians also judge benefit by changes in disability and headache impact. We examined how often frequency-based and patient-reported outcome measure (PROM) responder definitions classify the same individuals after CGRP-pathway monoclonal antibody treatment and characterized the direction of discordant response patterns.
Methods: We performed a secondary analysis of a public patient-level dataset including 417 patients treated with a first CGRP-pathway monoclonal antibody. Response was defined using source-study criteria: subtype-specific MMD response, Migraine Disability Assessment (MIDAS) response, and Headache Impact Test-6 (HIT-6) response. We quantified response rates, pairwise agreement, directional discordance, and continuous-change correlations. Exploratory logistic regression examined baseline features associated with discordant classification.
Results: MMD, MIDAS, and HIT-6 response occurred in 227/417 (54.4%), 243/417 (58.3%), and 254/417 (60.9%) patients, respectively. Only 131/417 (31.4%) met all three response definitions, and 207/417 (49.6%) had discordant classification across the three endpoints. Observed agreement between MMD and MIDAS response was 66.4% with kappa 0.32, and observed agreement between MMD…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 417 participants or records.
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