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The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study

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Abstract

Objective

To evaluate the frequency and headache-related impact response to monoclonal antibodies against calcitonin gene-related peptide (CGRP) in a clinical sample of refractory migraine patients.

Methods

We included migraine patients with ≥ 8 headache days/month that had failed at least three preventive medications. Demographic, medical and migraine history were collected. Patients completed an electronic headache diary including headache days/month, migraine days/month, headache pain intensity (0–3 numerical scale), use of analgesics and completed Patient-Reported Outcome questionnaires at baseline and after 12 weeks. Patients were classified into ≥ 50%, ≥ 75% and 100% responders according to the improvement in frequency.

Results

We included 155 patients (109 erenumab and 46 galcanezumab). After 12 weeks, headache frequency decreased − 9.1 headache days/month and − 8.5 migraine days/month from baseline. A 39.5% had a ≥ 50% headache days/month reduction and a 51.6% ≥ 50% migraine days/month reduction. In the ≥ 50% migraine days/month-responders group, frequency reduction was − 13,9 migraine days/month from baseline and showed clear improvements for all patient-reported outcomes. A 14.2% and 26.5% had a ≥ 75% response in headache and migraine days/month, respectively, and 11.0% showed a 100% migraine days/month reduction. Patients who were not on other preventive medications had less severe disability and higher ratio of migraine over headache days/month were more likely of being a ≥ 50% migraine days/month-responder. We did not record any severe adverse events, being the most common constipation (20.0%), fatigue (7.1%) and a transient increase in blood pressure (5.2%).

Conclusions

In real-world clinical practice, monoclonal antibodies against CGRP proved to be effective treatments in resistant migraine patients.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Funding

The authors received no specific funding for this work.

Author information

Authors and Affiliations

  1. Headache Unit, Neurology Department, Hospital Universitari Vall d’Hebron, 119-129 Passeig de la Vall d’Hebron, 08035, Barcelona, Spain

    Marta Torres-Ferrús, Alicia Alpuente, Eulalia Gine-Cipres & Patricia Pozo-Rosich

  2. Headache and Neurological Pain Research Group, Vall d’Hebron Research Institute, Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, Spain

    Marta Torres-Ferrús, Victor J. Gallardo, Alicia Alpuente, Edoardo Caronna, Eulalia Gine-Cipres & Patricia Pozo-Rosich

Authors
  1. Marta Torres-Ferrús
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  2. Victor J. Gallardo
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  3. Alicia Alpuente
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  4. Edoardo Caronna
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  5. Eulalia Gine-Cipres
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  6. Patricia Pozo-Rosich
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Contributions

All authors made substantial contributions to conception and study design and data collection. VJG contributed to analysis and interpretation of data. MTF wrote first draft. AA, EC, PPR critically revised for important intellectual content. All authors finally approved the version to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Patricia Pozo-Rosich.

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Conflicts of interest

Marta Torres-Ferrus has received honoraria as a consultant or speaker for Allergan-Abbvie, Almirall, Chiesi, Eli Lilly, Novartis and Teva. Alpuente A has received honoraria from Allergan plc, Novartis, Chiesi. Cipres-Gine E has received honoraria from Eli Lilly, Novartis and Teva. Victor J and Caronna E reports no diclosures. Pozo-Rosich P has received honoraria as a consultant and speaker for: Allergan-Abbvie, Almirall, Amgen, Biohaven, Chiesi, Eli Lilly, Medscape, Neurodiem, Novartis and Teva. Her research group has received research grants from Allergan, and has received funding for clinical trials from Alder, Allergan-Abbvie, Electrocore, Eli Lilly, Novartis and Teva. She is a trustee member of the board of the International Headache Society, member of the Council of the European Headache Society. She is in the editorial board of Revista de Neurologia, associate editor for Cephalalgia, Headache, Neurologia, Frontiers of Neurology and The Journal of Headache and Pain. She is a member of the Clinical Trials Guidelines Committee of the International Headache Society. She has edited the Guidelines for the Diagnosis and Treatment of Headache of the Spanish Neurological Society. She is the founder of www.midolordecabeza.org. Pozo-Rosich P does not own stocks from any pharmaceutical company.

Ethics approval

Subjects’ consent was obtained according to the Declaration of Helsinki. The study was approved by Vall d’Hebron Ethics Committee.

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Patients gave their consent for participation.

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Patients gave their consent for publication.

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Torres-Ferrús, M., Gallardo, V.J., Alpuente, A. et al. The impact of anti-CGRP monoclonal antibodies in resistant migraine patients: a real-world evidence observational study. J Neurol 268, 3789–3798 (2021). https://doi.org/10.1007/s00415-021-10523-8

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  • DOI: https://doi.org/10.1007/s00415-021-10523-8

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