Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.

Autor: Barbanti P; Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy. piero.barbanti@sanraffaele.it.; San Raffaele University, Rome, Italy. piero.barbanti@sanraffaele.it., Egeo G; Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy., Proietti S; Clinical and Molecular Epidemiology, IRCCS San Raffaele, Rome, Italy.; Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy., d'Onofrio F; Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy., Aurilia C; Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy., Finocchi C; Neurology Unit, San Paolo Hospital, ASL 2, Savona, Italy., Di Clemente L; Headache Center, Neurology Unit, San Camillo-Forlanini Hospital, Rome, Italy., Zucco M; Headache Center, Neurology Unit, San Camillo-Forlanini Hospital, Rome, Italy., Doretti A; Laboratory of Neuroscience, Department of Neurology-Stroke Unit, Istituto Auxologico Italiano, IRCCS, Milano, Italy., Messina S; Laboratory of Neuroscience, Department of Neurology-Stroke Unit, Istituto Auxologico Italiano, IRCCS, Milano, Italy., Autunno M; Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy., Ranieri A; Neurology Unit and Stroke-Unit, AORN A. Cardarelli, Naples, Italy., Carnevale A; Headache Center, Neurology Unit, San Filippo Neri Hospital, Rome, Italy., Colombo B; Department of Neurology, Headache Unit, Scientific Institute San Raffaele Hospital, Vita-Salute University, Milan, Italy., Filippi M; Department of Neurology, Headache Unit, Scientific Institute San Raffaele Hospital, Vita-Salute University, Milan, Italy., Tasillo M; Stroke Unit, S. Camillo de Lellis Hospital, Rieti, Italy., Rinalduzzi S; Stroke Unit, S. Camillo de Lellis Hospital, Rieti, Italy., Querzani P; Neurology Unit, S. Maria Delle Croci Hospital-AUSL Romagna, Ravenna, Italy., Sette G; Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), Sant'Andrea University Hospital, 'Sapienza' University of Rome, Rome, Italy., Forino L; Neurology Unit, San Giuseppe Moscati Hospital, Avellino, Italy., Zoroddu F; Neurology Unit, Pediatric Headache Center, University of Sassari, Sassari, Italy., Robotti M; Headache Center, ASST Santi Paolo Carlo, Milan, Italy., Valenza A; Headache Center, UOC Neurology, Ospedale Belcolle, Viterbo, Italy., Camarda C; Department of Biomedicine, Neurosciences, and Advanced Diagnostics, University of Palermo, Palermo, Italy., Borrello L; Frosinone Hospital, Headache Center, Frosinone, Italy., Aguggia M; Neurology and Stroke Unit, Cardinal Massaia Hospital, Asti, Italy., Viticchi G; Neurological Clinic, Marche Polytechnic University, Ancona, Italy., Tomino C; Scientific Direction IRCCS San Raffaele, Rome, Italy., Fiorentini G; San Raffaele University, Rome, Italy., Orlando B; Headache and Pain Unit, IRCCS San Raffaele, Via Della Pisana 235, 00163, Rome, Italy., Bonassi S; Clinical and Molecular Epidemiology, IRCCS San Raffaele, Roma, Italy.; Department of Human Sciences and Quality of Life Promotion, San Raffaele University, Rome, Italy., Torelli P; Department of Medicine and Surgery, Headache Center, Neurology Unit, University of Parma, Parma, Italy.
Jazyk: angličtina
Zdroj: Neurology and therapy [Neurol Ther] 2024 Jun; Vol. 13 (3), pp. 611-624. Date of Electronic Publication: 2024 Mar 07.
DOI: 10.1007/s40120-024-00591-z
Abstrakt: Introduction: Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and various comorbidities.
Methods: A 48-week, prospective, multicenter (n = 26), cohort study assessed fremanezumab's effectiveness, safety, and tolerability in consecutive adults with HFEM or CM with > 3 treatment failures. Primary endpoint was variation from baseline in monthly migraine days (MMD) in HFEM and monthly headache days (MHD) in CM at weeks 45-48. Secondary endpoints were changes in monthly analgesic medications, Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), and the Migraine Disability Assessment Scale (MIDAS) scores and ≥ 50%, ≥ 75%, and 100% responder rates.
Results: Of 533 participants who had received ≥ 1 fremanezumab dose, 130 were treated for ≥ 48 weeks and considered for effectiveness analysis. No participant missed any treatment dosage every other consecutive month during the 12-month period.
Primary Endpoint: fremanezumab significantly (p < 0.001) reduced both MMD (- 6.4) in HFEM and MHD (- 14.5) in CM. Secondary endpoints: a significant reduction (p < 0.001) was observed in monthly analgesic medications (HFEM - 6.0; CM -16.5), NRS (HFEM - 3.4; CM - 3.4), HIT-6 (HFEM - 16.9; CM - 17.9) and MIDAS score (HFEM - 50.4; CM - 76.6). The ≥ 50%, ≥ 75%, and 100% response rates to fremanezumab were 75.5%, 36.7%, and 2% in HFEM and 71.6%, 44.4%, and 3.7% in CM. Corresponding response rates were 60.5%, 37.2%, and 2.3% in individuals with psychiatric comorbidities, 74.2%, 50%, and 4.8% in CM with medication overuse, and 60.9%, 39.1%, and 4.3% in CM with medication overuse and psychiatric comorbidities. Mild and transient treatment-emergent adverse events occurred in 7.8% of the participants. No subject discontinued the treatment for any reason.
Conclusion: This RWE study documents that long-term fremanezumab treatment is highly effective and remarkably well tolerated in subjects with HFEM or CM with multiple (> 3) therapeutic failures, even in the presence of concomitant medication overuse, psychiatric comorbidities, or both. The effectiveness-to-tolerability ratio appears to be better in RWE than in RCTs.
(© 2024. The Author(s).)
Databáze: MEDLINE
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