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Observational Study
. 2025 Oct 9;272(10):683.
doi: 10.1007/s00415-025-13419-z.

Super- and absolute responders to anti-cgrp monoclonal antibodies in migraine: A one-year multicenter, prospective, observational study

Piero Barbanti  1   2 , Cinzia Aurilia  3 , Giulia Fiorentini  3   4 , Gabriella Egeo  3 , Davide Mascarella  5 , Stefania Proietti  6 , Roberta Messina  7   8 , Massimo Filippi  7   8 , Stefano Bonassi  4   9 , Paola Torelli  10 , Sabina Cevoli  5 ; Italian Migraine Registry study group
Affiliations
Observational Study

Super- and absolute responders to anti-cgrp monoclonal antibodies in migraine: A one-year multicenter, prospective, observational study

Piero Barbanti et al. J Neurol. .

Abstract

Aim: To assess the frequency of super-responders (≥ 75% reduction in migraine frequency) and absolute responders (100% reduction) to monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) after one year of treatment in individuals with high frequency (HFEM) or chronic migraine (CM).

Methods: This multicenter (n = 16), prospective, real-life study, involved consecutive adults with HFEM or CM and ≥ 3 prior preventive failures, receiving subcutaneous anti-CGRP mAbs for ≥ 12 months. Co-primary endpoints were the 12-month rates of super- and absolute responders. Secondary endpoints included subgroup analyses by migraine type and timing of response, categorized as early (≤ 3 months), late (> 3-6 month), or ultra-late (> 6-12 month).

Results: 572 patients completed 12 months of treatment: 70.0% achieved super-response (HFEM: 64.9%; CM: 71.8%) and 23.4% absolute response (HFEM: 29.9%; CM: 21.0%). Both outcomes exhibited a time-dependent progression. Among super-responders (n = 400), 29.4% were early, 22.6% late, and 18.0% ultra-late. Among absolute responders (n = 134), 3.1% responded early, 3.7% late, and 16.6% ultra-late.

Conclusion: One year of anti-CGRP mAbs therapy yields a ≥ 75% response in over two-thirds and a 100% response in nearly one-quarter of patients with HFEM or CM and prior treatment failures. Most super- and absolute responses emerge after six months, supporting long-term continuation treatment.

Keywords: Absolute response; Anti-CGRP mAbs; Migraine; Real-life; Super-response.

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Conflict of interest statement

Declarations. Conflicts of interest: Piero Barbanti received travel grants, honoraria for advisory boards, speaker panels or clinical investigation studies from Abbvie, Alder, Angelini, Assosalute, Biohaven, DOC Pharma, Eli-Lilly, Fondazione Ricerca e Salute, GSK, Lundbeck, Noema Pharma, Organon, Orion Pharma, Pfizer, Teva, Viatris, Visufarma, and serves as President with Italian Association of Headache Sufferers. Cinzia Aurilia received travel grants from Eli-Lilly, Teva and Pfizer, honoraria from Teva; Giulia Fiorentini have no disclosures to declare, Gabriella Egeo received travel grants and honoraria from Eli-Lilly, TEVA and Lundbeck. Davide Mascarella received travel grants Abbvie, Organon, Teva and educational grant from Eli Lilly and Organon; Stefania Proietti have no disclosures to declare; Roberta Messina received honoraria for speaker activities and participating in advisory boards from Abbvie, Biomedia, Eli Lilly, Lundbeck, Organon, Pfizer and Teva; Massimo Filippi is Editor-in-Chief of the Journal of Neurology; received compensation for consulting services and/or speaking activities from Bayer, Biogen Idec, Merck-Serono, Novartis, Roche, Sanofi Genzyme, Takeda, and Teva; and receives research support from Biogen Idec, Merck-Serono, Novartis, Roche, Teva, Italian Ministry of Health, Fondazione Italiana Sclerosi Multipla, and ARiSLA (Fondazione Italiana di Ricerca per la SLA); Stefano Bonassi have no disclosures to declare; Paola Torelli received travel grant, honoraria as a speaker, or for participating in advisory boards from Teva, Eli Lilly, Allergan, Organon, Pfizer, Lundbeck and Abbvie; Sabina Cevoli received honoraria for speaker panels from Teva, Abbvie and Organon.

Figures

Fig. 1
Fig. 1
Patients' disposition
Fig. 2
Fig. 2
Proportion of all migraine patients achieving a ≥ 75% reduction in monthly migraine/headache days from baseline during treatment with anti-CGRP mAbs. Light grey bars represent early super-responders (≥ 75% reduction within 3 months), red bars late super-responders (> 3 to ≤ 6 months), and blue bars ultra-late super-responders (> 6 to ≤ 12 months). White bars represent individuals who had not yet achieved a ≥ 75% reduction at the corresponding time point
Fig. 3
Fig. 3
Proportion of all migraine patients achieving a 100% reduction in monthly migraine/headache days from baseline during treatment with anti-CGRP mAbs. Light grey bars represent early absolute responders (100% reduction within 3 months), red bars late absolute responders (> 3 to ≤ 6 months), and blue bars ultra-late absolute responders (> 6 to ≤ 12 months). White bars represent individuals who had not yet achieved a 100% reduction at the corresponding time point
Fig. 4
Fig. 4
Proportion of patients with high-frequency episodic migraine (HFEM, panel A) or chronic migraine (CM, panel B) achieving a ≥ 75% reduction in monthly migraine/headache days from baseline during treatment with anti-CGRP mAbs. Light grey bars represent early super-responders (≥ 75% reduction within 3 months), red bars late super-responders (> 3 to ≤ 6 months), and blue bars ultra-late super-responders (> 6 to ≤ 12 months). White bars represent individuals who had not yet achieved a ≥ 75% reduction at the corresponding time point
Fig. 5
Fig. 5
Proportion of patients with high-frequency episodic migraine (HFEM, panel A) or chronic migraine (CM, panel B) achieving a 100% reduction in monthly migraine/headache days from baseline during treatment with anti-CGRP mAbs. Light grey bars represent early absolute responders (100% reduction within 3 months), red bars late absolute responders (> 3 to ≤ 6 months), and blue bars ultra-late absolute responders (> 6 to ≤ 12 months). White bars represent individuals who had not yet achieved a 100% reduction at the corresponding time point
See this image and copyright information in PMC

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