Luigi Francesco Iannone, Elisa Maria Piella, Danilo Antonio Montisano, Carla Fasano, Gabriele Sebastianelli, Gianluca Coppola, Delfina Ferrandi, Claudia Lanni, Maria Pia Prudenzano, Marina de Tommaso, Paola Merlo, Francesco De Cesaris, Alberto Chiarugi, Antonio Munafò, Francesca Pistoia, Raffaele Ornello, Alberto Doretti, Licia Grazzi, Flavia Lo Castro, R. De Icco, Gloria Vaghi, Gianluca Avino, Marina Romozzi, Paolo Calabresi, Stefania Battistini, Alessandra Rufa, Maria Albanese, Michele Trimboli, Giovanna Carlucci, Marcello Silvestro, Antonio Russo, Innocenzo Rainero, Maria Rosaria Valente, Luisa Fofi, Marilena Marcosano, Pierangelo Geppetti, Claudia Altamura, Fabrizio Vernieri, Cristina Tassorelli, Simona Sacco, Simona Guérzoni, on behalf of the Italian Headache Registry (RICe) Study Group
" 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.