The Management of High-Frequency Episodic and Chronic Migraines with Calcitonin Gene-Related Peptide Monoclonal Antibody

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Abstract

Introduction. High prevalence of migraine and its impact on quality of life requires the development of original agents. In 2020, fremanezumab, a new calcitonin gene-related peptide monoclonal antibody was authorized in Russia.

Objective: to evaluate safety and effectiveness of fremanezumab in patients with high-frequency episodic migraine (HF EM) and chronic migraine (CM).

Materials and methods. We assessed 60 patients at the age of 35.5 ± 8.96 years (85%, females) with HFEM and CM with and without aura who were either receiving preventive treatment or not. Fremanezumab was administered subcutaneously at a single dose of 675 mg. The study participants were followed-up for efficacy in 3 months. The investigators assessed change in the number of days with headache per month as well as headache intensity, its impact on the daily activities, anxiety, and depression.

Results. By the end of month 3 post dosing, the number of days with headache decreased by >50% in 76.7% of participants where 77.8% of individuals suffered from HF EM and 72.7% of individuals had CM while headache intensity decreased in all the patients equally. No response (decrease in the number of days with headache by < 30%) was reported in 15% of participants including 14.8% of individuals with HF EM and 15.2% of individuals with CM. By the end of study month 3, 81% of participants demonstrated no anxiety symptoms and 79% of participants showed no depression with significant MIDAS and HIT-6 score decline in both groups. Only 3 (5%) patients noted adverse events (redness, itching at the administration site).

Conclusion. We documented higher fremanezumab safety and effectiveness in patients with EM and CM in real-world practice as compared to fremanezumab safety and efficacy in randomized clinical trials. A single dose of fremanezumab (675 mg) resulted in effective migraine prevention, decline in comorbid anxiety and depression, and improved quality of life during 3-month follow-up.

About the authors

Larisa A. Dobrynina

Research Center of Neurology

Author for correspondence.
Email: dobrla@mail.ru
ORCID iD: 0000-0001-9929-2725

D. Sci. (Med.), chief researcher, Head, 3rd Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Maksim A. Afanasev

Research Center of Neurology

Email: m.afan.doc@gmail.com
ORCID iD: 0000-0001-5552-3704

postgraduate student, neurologist, 3rd Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Anastasia V. Belopasova

Research Center of Neurology

Email: mastusha@yandex.ru
ORCID iD: 0000-0003-3124-2443

Cand. Sci. (Med.), researcher, 3rd Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Maria V. Gubanova

Research Center of Neurology

Email: m.v.gubanova@yandex.ru
ORCID iD: 0000-0002-9893-712X

Cand. Sci. (Med.), researcher, 3rd Neurological department, Institute of Clinical and Preventive Neurology

Russian Federation, Moscow

Ekaterina V. Baydina

Research Center of Neurology

Email: glavvrach@neurology.ru
ORCID iD: 0000-0001-5911-5855

Cand. Sci. (Med.), chief physician

Russian Federation, Moscow

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Supplementary files

Supplementary Files
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1. JATS XML
2. Fig. 1. Decrease in the number of days with headache by the end of month 3 post fremanezumab dosing.

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3. Fig. 2. Migraine impact on daily activities, MIDAS score.

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4. Fig. 3. Migraine impact on daily activities, HIT-6 score.

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Copyright (c) 2023 Dobrynina L.A., Afanasev M.A., Belopasova A.V., Gubanova M.V., Baydina E.V.

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This work is licensed under a Creative Commons Attribution 4.0 International License.

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