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Objective: To describe the pattern of anti-calcitonin gene-related peptide monoclonal antibodies (anti-CGRP mAbs) utilization in the Tuscany region, Italy, and the variation of triptan consumption after treatment initiation.
Background: Given the recent commercialization of anti-CGRP mAbs as migraine preventive medications, real-world evidence on their patterns of utilization and their impact on migraine abortive medication use is still limited.
Methods: A retrospective, descriptive, cohort study on the real-world utilization of anti-CGRP mAbs was performed using the population-based regional administrative database of Tuscany. Patients with ≥1 anti-CGRP mAb dispensing (namely erenumab, galcanezumab, fremanezumab) between April 1, 2019, and September 30, 2021, were identified. The first dispensing was the cohort entry (CE). New users (NUs) were patients with no anti-CGRP mAb dispensing before CE. Kaplan-Meier (KM) curves were plotted to describe the cumulative probability of remaining with the initial anti-CGRP mAb during a 15-month follow-up period as a measure of treatment persistence. Among NUs with ≥2 triptan dispensings during the 6 months before CE (i.e., baseline), the mean monthly number of triptan dosage units dispensed was measured in five consecutive follow-up time windows (months 1-3, 4-6, 7-9, 10-12, 13-15) and the difference from the baseline was calculated.
Results: A total of 624 NUs (erenumab = 295, galcanezumab = 223, fremanezumab = 106) were identified, of whom 188 (78%) were women. Mean age was 49.2 years (standard deviation [SD] = 12.6). The survival to discontinuation at 6, 12, and 15 months was about 69%, 48%, and 6%, respectively. The survival to switch was about 6% at 15 months. The observed variation of triptan consumption at 3/6/9/12/15 months and the corresponding SD was -4.4 [8.2]/-5.2 [9.0]/-5.5 [9.2]/-5.4 [9.2]/-4.5 [10.0], respectively.
Conclusion: Patient demographics reflect the place of these medications in therapy. Overall, findings seem to indicate a favorable tolerability and effectiveness profile. Further studies are warranted to better establish the long-term comparative effectiveness, safety, and cost effectiveness of anti-CGRP mAbs compared to other preventive medications.
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http://dx.doi.org/10.1111/head.14639 | DOI Listing |
Eur J Neurol
September 2025
Digital and Predictive Medicine, Pharmacology and Clinical Metabolic Toxicology-Headache Center and Drug Abuse-Laboratory of Clinical Pharmacology and Pharmacogenomics, AOU Policlinico di Modena, Modena, Italy.
Background: Migraine is associated with an increased cardiovascular risk, including hypertension. Anti-calcitonin gene related peptide (CGRP) monoclonal antibodies (mAbs) are effective preventive treatments, but concerns have been raised about their potential hypertensive effects. Herein, we assess the early changes in blood pressure (BP) during anti-CGRP mAbs treatment in patients with migraine using 24-h Holter monitoring.
View Article and Find Full Text PDFJ Headache Pain
September 2025
Digital and Predictive Medicine, Pharmacology, Clinical Metabolic Toxicology-Headache Center and Drug Abuse, AOU Policlinico di Modena, Modena, Italy.
Introduction: Real-world studies have explored potential predictors of response to anti-calcitonin gene related peptide (CGRP) monoclonal antibodies (mAbs), though results have remained inconsistent. Machine learning (ML) algorithms are becoming increasingly relevant in migraine research, offering a data-driven approach to identifying predictors of response to preventive treatments. To maximize their potential, a clinically applicable and user-oriented framework is needed to promote the use of these algorithms in research and, eventually, as supportive tools in clinical practice.
View Article and Find Full Text PDFCephalalgia
August 2025
Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
BackgroundThe present prospective, real-world study aims to assess anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) effectiveness across three consecutive one-year treatment cycles by means of a conservative intention-to-treat (ITT) analysis.MethodsWe enrolled 179 subjects (75.4% females, 51.
View Article and Find Full Text PDFTher Adv Neurol Disord
June 2025
Department of Systems Medicine, University of Rome Tor Vergata, via Montpellier 1, Rome 00133, Italy.
Background: Migraine is a disabling neurovascular disorder characterized by recurrent attacks that lead to extracranial and visual involvement. Several studies have investigated the retinal vasculature features in individuals with migraine, but there have been conflicting results.
Objective: To evaluate retinal structure in migraine patients before (T0) and after 6-month therapy (T1) with anti-calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs), using optical coherence tomography (OCT) imaging.
J Neurol
June 2025
Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Modena, Italy.
Background: This study aimed to compare the differences in clinical characteristics and response to monoclonal antibodies against CGRP (anti-CGRP mAbs) between patients who habitually used triptans (TRIPTANS group) and patients who were non-current users (NO-TRIPTANS group).
Methods: In this prospective cohort study, all consecutive outpatients treated with anti-CGRP mAbs for 12 months were included. Clinical data were collected at baseline and monthly: number of headache days (MHDs), the absolute number of analgesics (AMNs), and the number of days with at least one analgesic (AMDs), Headache Impact Test-6 (HIT-6), and Migraine Disability Assessment (MIDAS) questionnaires.