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Background <p>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.</p> Methods <p>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.</p> Results <p>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 and HIT-6 response was 68.6% with kappa 0.36. When MMD was compared with any PROM response, PROM-only response occurred in 111/417 (26.6%) patients and frequency-only response in 18/417 (4.3%). Correlations between continuous improvements in frequency-based and patient-reported outcomes were moderate rather than strong.</p> Conclusions <p>After CGRP-pathway monoclonal antibody treatment, responder classification depended on whether response was defined by migraine frequency, disability, or headache impact. PROM-only response was more frequent than frequency-only response, suggesting that some patients may report meaningful improvement in disability or impact even when they do not cross diary-based frequency thresholds. These findings do not establish a new responder definition or show that one endpoint is superior; they support complementary reporting of headache frequency and patient-reported burden.</p> Trial registration <p>Not applicable.</p>

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Responder discordance between migraine frequency and patient-reported outcomes after CGRP-pathway monoclonal antibody treatment: a secondary analysis of public patient-level data

  • 期刊论文

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  • 发表日期：

    2026年6月15日

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  • Chuntao Wu,
  • Junwei Wang,
  • Shuai Zhao,
  • Yinxin Wang,
  • Tong Wu

摘要

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 and HIT-6 response was 68.6% with kappa 0.36. When MMD was compared with any PROM response, PROM-only response occurred in 111/417 (26.6%) patients and frequency-only response in 18/417 (4.3%). Correlations between continuous improvements in frequency-based and patient-reported outcomes were moderate rather than strong.

Conclusions

After CGRP-pathway monoclonal antibody treatment, responder classification depended on whether response was defined by migraine frequency, disability, or headache impact. PROM-only response was more frequent than frequency-only response, suggesting that some patients may report meaningful improvement in disability or impact even when they do not cross diary-based frequency thresholds. These findings do not establish a new responder definition or show that one endpoint is superior; they support complementary reporting of headache frequency and patient-reported burden.

Trial registration

Not applicable.