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HOME > Epilessia, la terapia aggiuntiva con cenobamato migliora il controllo delle crisi
Epilessia, la terapia aggiuntiva con cenobamato migliora il controllo delle crisi
Il 28% dei pazienti trattati ha raggiunto l’assenza di attacchi nella fase di mantenimento dello Studio 013
In questo studio in doppio cieco, randomizzato e controllato con placebo, 222 pazienti con crisi epilettiche ad esordio focale non controllate, che assumevano da 1 a 3 farmaci anti-crisi (ASM, Anti-Seizure Medication), sono stati randomizzati a ricevere placebo o cenobamato 200 mg una volta al giorno, al fine di valutare la sicurezza e l’efficacia del farmaco nel corso di un periodo di trattamento in doppio cieco di 12 settimane. In media, i pazienti che sono stati arruolati nello studio presentavano 6,5 crisi al mese al momento della loro inclusione.
I principali risultati della sperimentazione hanno evidenziato una riduzione significativamente maggiore della frequenza mediana delle crisi nel gruppo trattato con cenobamato rispetto al gruppo placebo (56% e 22%, rispettivamente); oltretutto, un numero significativamente maggiore di pazienti trattati con cenobamato ha raggiunto una riduzione del 50% o superiore della frequenza delle crisi durante il periodo in doppio cieco rispetto ai soggetti del gruppo placebo (50% e 22%, rispettivamente). Infine, le analisi post-hoc dei dati derivanti dalla fase di mantenimento hanno mostrato che percentuali significativamente maggiori di pazienti trattati con cenobamato, rispetto a quelli trattati con placebo, hanno raggiunto tassi di riduzione delle crisi ≥75% (39% e 21%, rispettivamente), ≥90% (34% vs 9%, rispettivamente) e del 100% (28% e 9%, rispettivamente).
Gli eventi avversi emersi durante il trattamento (TEAE; Treatment-Emergent Adverse Event) riportati in oltre il 10% dei pazienti in entrambi i gruppi di trattamento (cenobamato o placebo) hanno incluso sonnolenza (22% e 12%, rispettivamente), capogiri (22% e 17%, rispettivamente), cefalea (12% e 13%, rispettivamente), nausea (12% e 5%, rispettivamente) e affaticamento (11% e 6%, rispettivamente). I tassi di interruzione dello studio sono risultati simili nei gruppi cenobamato (n=11, 10%) e placebo (n=10, 9%).
“Questo studio rappresenta un importante progresso nello sviluppo di cenobamato per i pazienti adulti con crisi ad esordio focale, e la sua pubblicazione su Neurology aggiunge ulteriori prove di evidenza dell’efficacia e sicurezza del farmaco”, ha dichiarato Ilise Lombardo, Co-Fondatrice e Chief Medical Officer di Arvelle Therapeutics. “I risultati dello studio suggeriscono che cenobamato può rappresentare una potenziale opzione di trattamento per i pazienti che continuano ad avere crisi nonostante l’uso dei trattamenti disponibili”.
Sulla rivista Epilepsia è stato inoltre pubblicato un report ad interim dei risultati derivanti da uno studio clinico di Fase III, in aperto, tuttora in corso, condotto con cenobamato su 1339 adulti con crisi focali non controllate. Nel report non sono stati identificati nuovi problemi di sicurezza circa l’utilizzo di cenobamato come terapia aggiuntiva. Inoltre, è stato osservato un elevato tasso di ritenzione (DRR) del farmaco, pari all’83%. Il DRR indica la percentuale di pazienti che mantengono la terapia con un dato medicinale per un determinato periodo di tempo. In base ai dati pubblicati, non è stato rilevato nessun caso di DRESS (reazione al farmaco con eosinofilia e sintomi sistemici).
“I risultati di entrambi gli studi – ha aggiunto Ilise Lombardo – suggeriscono che cenobamato può svolgere un ruolo importante nell’alleviare le difficoltà di un gran numero di pazienti epilettici che continuano ad avere attacchi nonostante l’uso dei trattamenti disponibili. Questi dati sono molto incoraggianti per molti pazienti affetti da epilessia ad esordio focale”.
L’Agenzia Europea per i Medicinali (EMA) sta valutando l’approvazione del cenobamato come trattamento aggiuntivo delle crisi a esordio focale negli adulti con epilessia. In Europa, si stima ci siano circa sei milioni di persone affette da epilessia e approssimativamente il 40% dei pazienti adulti con malattia focale ha un controllo inadeguato delle crisi dopo il trattamento con due ASM.
Fonte originale www.osservatoriomalattierare.it
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