Cephalalgia : an international journal of headache · 2026
Levels of migraine controls following International Headache Society (IHS) recommendations with eptinezumab: Effectiveness and tolerability in a 24-week, prospective multicenter study (the TACHIS study).
СтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Iannone Luigi Francesco, Piella Elisa Maria, Montisano Danilo Antonio, Fasano Carla, Sebastianelli Gabriele, Coppola Gianluca, Ferrandi Delfina, Lanni Claudia, Prudenzano Maria Pia, de Tommaso Marina, Merlo Paola, De Cesaris Francesco, Chiarugi Alberto, Munafò Antonio, Pistoia Francesca, Ornello Raffaele, Doretti Alberto, Grazzi Licia, Lo Castro Flavia, De Icco Roberto, Vaghi Gloria, Avino Gianluca, Romozzi Marina, Calabresi Paolo, Battistini Stefania, Rufa Alessandra, Albanese Maria, Trimboli Michele, Carlucci Giovanna, Silvestro Marcello, Russo Antonio, Rainero Innocenzo, Valente Maria Rosaria, Fofi Luisa, Marcosano Marilena, Geppetti Pierangelo, Altamura Claudia, Vernieri Fabrizio, Tassorelli Cristina, Sacco Simona, Guerzoni Simona, Italian Headache Registry (RICe) Study Group
Аннотация
AimThe TACHIS study (from the ancient Greek adjective "tachýs" meaning rapid) aimed to evaluate eptinezumab effectiveness and tolerability in routine clinical practice, integrating patient-reported outcomes and use of International Headache Society (IHS)-endorsed categories of migraine control by treatment.BackgroundEptinezumab is the only intravenous anti-calcitonin gene related peptide (CGRP) monoclonal antibody (mAb) approved for migraine prevention. While its efficacy has been demonstrated in RCTs, real-world evidence in patients with prior preventive treatment failures is still limited.MethodsTACHIS is a prospective, multicenter, observational study conducted in Italy. Adults with episodic or chronic migraine initiating eptinezumab were followed for 24 weeks. Primary outcomes included change from baseline in monthly migraine days (MMDs) and ≥50% responder rate. Secondary outcomes included changes from baseline in acute medication use, Migraine Disability Assessment (MIDAS) and Headache Impact Test-6 (HIT-6) and IHS-defined residual burden categories. Logistic regression identified factors of response status.ResultsA total of 128 patients were included (82% female; 82% chronic migraine). MMDs decreased overall by 5.7 days (95% CI: -7.2 to -4.3) at week 12 and 6.9 (95% CI: -8.5 to -5.2) at week 24 (p < 0.001). A ≥ 50% response was achieved in 43.8% and 48.2% of patients at weeks 12 and 24, respectively. Over 40% of patients achieved optimal or modest migraine control. CGRP targeted therapy-naïve patients experienced significant greater benefit, though non-naïve patients also improved. Female sex and chronic migraine diagnosis were independently associated with response at 12 weeks. Adverse events were infrequent (4.7%) and mild, with no discontinuations due to safety concerns.ConclusionsEptinezumab demonstrated effectiveness and tolerability in a real-world population of patients with migraine and prior preventive treatment failures. The integration of migraine control metrics provides a comprehensive evaluation of therapeutic impact and supports eptinezumab use in routine care.Trial RegistrationThe TACHIS study was preregistered on clinicaltrial.gov, NCT06409845.