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. 2026 Feb;15(1):401-420.
doi: 10.1007/s40120-025-00872-1. Epub 2025 Dec 17.

Real-World Experience with Anti-CGRP Pathway Monoclonal Antibodies in a Large United States Healthcare Plan: Results of the Migraine Signature Study

Dawn C Buse  1 , Richard B Lipton  1   2 , Robert Urman  3 , Shruti J Vaidya  4 , Sarah C Robinson  4 , Alice S Jacobson  4 , Alexandra B Scott  4 , Mark E Bensink  5 , Alice R Pressman  6   7
Affiliations

Real-World Experience with Anti-CGRP Pathway Monoclonal Antibodies in a Large United States Healthcare Plan: Results of the Migraine Signature Study

Dawn C Buse et al. Neurol Ther. 2026 Feb.

Abstract

Introduction: Calcitonin gene-related peptide (CGRP) pathway-targeted monoclonal antibodies (mAbs) are first-line treatment options for migraine prevention. Data on persistence and patient-reported outcomes including satisfaction are limited. This real-world study aimed to report the experience of patients prescribed ≥ 1 self-injectable anti-CGRP mAb in a large United States healthcare network.

Methods: The Migraine Signature Study, an observational study, conducted at Sutter Health, utilized electronic health records (EHRs) to identify adult patients with migraine who were prescribed ≥ 1 self-injectable anti-CGRP mAb. These patients were invited to participate in a survey (October-December 2020) on sociodemographics, migraine attack characteristics, treatment patterns, and patient-reported outcomes, including the Migraine Disability Assessment Scale (MIDAS) and 4-item Migraine Interictal Burden Scale (MIBS-4). EHRs were used to assess persistence/discontinuation.

Results: Of 4683 eligible patients with migraine, 484 (10.3%) completed the survey. More than half (51%) were 30-54 years old, female (89.1%), and non-Hispanic white (79.1%). Most (53.5%) reported 1-10 headache days in the previous month; 58.2% had moderate or severe migraine-related disability. A total of 430 respondents reported having used ≥ 1 anti-CGRP mAbs, comprising 547 reports of anti-CGRP-mAb experience, 319 (58.3%) current use, and 228 (41.7%) past use. Among participants with prescription-dispensing data (n = 338), ongoing refills were documented for ≥ 2 months in 90.2%, ≥ 6 months in 73.7%, and ≥ 12 months in 54.7%. Greater reduction in number of headache/migraine attacks (62.1% vs. 17.5%), improved ability to function (62.1% vs. 18.0%), and better quality of life (62.4% vs. 17.5%) was reported for current use versus past.

Conclusion: Among patients who dispensed ≥ 1 anti-CGRP mAb for migraine, rates of sustained treatment over the course of a year were higher than expected; ~ 75% continued their index mAb at 6 months and > 50% at 12 months. Patients using anti-CGRP mAbs at the time of the survey reported higher satisfaction than patients who had discontinued anti-CGRP mAb.

Keywords: Anti-CGRP mAbs; Migraine; Patient-reported outcomes; Real-world; Satisfaction.

Plain language summary

In clinical trials, calcitonin gene-related peptide (CGRP) pathway-targeted monoclonal antibodies (mAbs) have been shown to be effective in preventing migraine and have few side effects. Therefore, they are recommended as a first-line treatment option for migraine prevention. Data on persistence and patient-reported outcomes in real-world clinical practice are limited. In this study, we included patients with migraine who received treatment in a large United States healthcare network. We conducted a web-based survey of patients, identified from electronic health records, who were prescribed ≥ 1 of the 3 injectable anti-CGRP-targeted mAbs. Combining the survey data with prescription dispensing data, we assessed persistence, patient satisfaction with perceived effectiveness, tolerability and access, additional treatment use, migraine-related disability, quality of life, and other outcomes. Approximately three-quarters of patients who started an anti-CGRP- mAb continued to use that medication at 6 months and half of them continued at 1 year. Satisfaction levels were higher for current use of anti-CGRP mAb medications on treatment effectiveness, tolerability and side effects, improved ability to function, and quality of life compared to past use of mAbs. Among patients who discontinued an anti-CGRP mAb, approximately half reported a lack of effectiveness as the main reason for discontinuation, followed by side effects.

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Conflict of interest statement

Declarations. Conflict of Interest: Dawn C. Buse: research support from the US Food and Drug Administration (FDA) and the National Headache Foundation; consultant, advisory board member, or honoraria or research support from AbbVie/Allergan, Amgen, Biohaven, Eli Lilly and Company, Lundbeck, Novartis, Teva, and Theranica. Richard B. Lipton: research support from the National Institutes of Health, US FDA, and the National Headache Foundation; consultant, advisory board member, or honoraria or research support from AbbVie/Allergan, Amgen, Axsome, Biohaven, Eli Lilly and Company, GlaxoSmithKline, Lundbeck, Merck, Novartis, Pfizer, Teva, Vector, and Vedanta Research; royalties from Wolff’s Headache, 8th edition (Oxford University Press, 2009) and Informa; stock/options in Axon, Biohaven, Cooltech, and Manistee. Robert Urman: employee and stockholder of Amgen Inc. Mark E. Bensink: was an employee of Amgen Inc. during study design and initiation and subsequently the Managing Director of Benofit Consulting, which received consulting fees from Amgen Inc. to support the interpretation of study results. Sarah C. Robinson, Shruti J. Vaidya, Alice S. Jacobson, Alexandra B. Scott, Alice R. Pressman: No conflicts of interest to declare. Ethical Approval: The study was approved by the Sutter Health Institutional Review Board. Informed consent was collected from the survey participants. Additional Information: Erenumab was codeveloped in partnership with Amgen Inc. and Novartis.

Figures

Fig. 1
Fig. 1
Participant flow diagram. All reports are limited to the reported use of erenumab, galcanezumab, and fremanezumab. Of the 484 patients, 22 reported “no” to have taken an anti-CGRP mAb and the remaining 32 either did not answer or did not know. Of the 430 respondents who reported the use of anti-CGRP mAb, 105 reported using more than one type of mAb medication. CGRP calcitonin gene-related peptide, EHR electronic health record, mAb monoclonal antibody
Fig. 2
Fig. 2
Migraine-related disability, ictal, interictal and family burden, psychological symptomology, and quality of life among all survey respondents. *MIDAS was asked among patients who reported a headache in the past 90 days. GAD-7 Generalized Anxiety Disorder 7-item instrument, IMPACS Impact of Migraine on Partners and Children Scale, MIBS-4 4-item Migraine Interictal Burden Scale, MIDAS Migraine Disability Assessment Scale, PHQ-8 Patient Health Questionnaire 8-item instrument (depression), MSQOL Migraine-Specific Quality of Life
Fig. 3
Fig. 3
Persistence to index anti-CGRP mAb over one year. The Kaplan–Meier curve represents the sample of patients with ≥ 1 dispensed order for the index anti-CGRP mAb within 60 days of an order identified through EHR data (n = 338). Persistence is presented in 1-month intervals. CGRP calcitonin gene-related peptide, EHR electronic health record, mAb monoclonal antibody
Fig. 4
Fig. 4
Ratings of satisfaction and side effects by current and past anti-CGRP mAb use reports. Data were categorized into four categories using a 101-point sliding numerical rating scale where 0 = worst or lowest and 100 = best or highest. *Respondents provided data on all of the anti-CGRP mAb(s) that they had previously used. CGRP calcitonin gene-related peptide, mAb monoclonal antibody
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