Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug‐resistant focal epilepsy. (13th March 2019)

• Record Type: Journal Article
• Authors: Mula, Marco; Zaccara, Gaetano; Galimberti, Carlo Andrea; Ferrò, Bruno; Canevini, Maria Paola; Mascia, Addolorata; Mecarelli, Oriano; Michelucci, Roberto; Pisani, Laura Rosa; Specchio, Luigi Maria; Striano, Salvatore; Perucca, Emilio
• Other Names: Valisi Cristina investigator.; Paladin Francesco investigator.; Dainese Filippo investigator.; Eleopra Roberto investigator.; Lettieri Christian investigator.; Pauletto Giada investigator.; Zanoni Tiziano investigator.; Ferlisi Monica investigator.; Pierini Francesco investigator.; Ranzato Federica investigator.; Cantisani Teressa Anna investigator.; Piersanti Chiara investigator.; Nardini Federica investigator.; Cecconi Michela investigator.; Foschi Nicoletta investigator.; Fiori Chiara investigator.; Petrelli Cristina investigator.; Rocchi Raffaele investigator.; Celli Lorenzo investigator.; Marino Daniela investigator.; Aloisi Paolo investigator.; Iudice Alfonso investigator.; Bartolini Emanuele investigator.; Paganini Marco investigator.; Romoli Anna Maria investigator.; Pizzo Francesca investigator.; Luciana Tramacere investigator.; Neve Angela La investigator.; Francavilla Teresa investigator.; Ladogana Marianna investigator.; Paciello Nicola investigator.; Boero Giovanni investigator.; Pascarella Maria Grazia investigator.; Giallonardo Anna Teresa investigator.; Fattouch Jiinane investigator.; Casciato Sara investigator.; Pulitano Patrizia investigator.; Zarabla Alessia investigator.; Feleppa Michele investigator.; D'Argento Maria Rosaria investigator.; Habetswallner Francesco investigator.; Martino Bernardo De investigator.; Cutolo Amelia investigator.; Marciani Maria Grazia investigator.; Romigi Andrea investigator.; Albanese Maria investigator.; Ianniciello Marta investigator.; Vito Marianna De investigator.; Gaudio Luigi Del investigator.; Franceschetti Silvana investigator.; Rossi Davide Sebastiano investigator.; Villani Flavio investigator.; Didato Giuseppe investigator.; Minicucci Fabio investigator.; Leopizzi Emanuela investigator.; Meletti Stefano investigator.; Mirandola Laura investigator.; Giovannini Giada investigator.; Micheluzzi Roberto investigator.; Riguzzi Patrizia investigator.; Tinuper Paolo investigator.; Mostacci Barbara investigator.; Broli Marcella investigator.; Scornavacca Giulia investigator.; Sechi Gianpietro investigator.; Fenu Silia investigator.; Fois Chiara investigator.; Marrosu Francesco investigator.; Orofino Gianni investigator.; Sofia Vito investigator.; Pappalardo Irene investigator.; Sueri Chiara investigator.; Giuliano Loretta investigator.; Daniele Ornella investigator.; Zummo Leila investigator.; Pisani Francesco investigator.; Loddo Giuseppe investigator.; Stilo Cesare investigator.; Aguglia Umberto investigator.; Leonardi Cinzia investigator.; Ferlazzo Edoardo investigator.; Bellavia investigator.; Consoli Domenico investigator.; Gattuso Caterina investigator.; Elia Maurizio investigator.; Figura Maria Grazia investigator.; Ottonello Gianadrea investigator.; Arecco Daniela investigator.; Gambardella Antonio investigator.; Pantusa Maria investigator.; Monti Fabrizio investigator.; Belluzzo Marco investigator.; Tomaselli Marinella investigator.; Bongiovanni Luigi Giuseppe investigator.; Brigo Francesco investigator.; Banfi Paola investigator.; Mariani Valeria investigator.;
• Is Part Of: Epilepsia. Volume 60:issue 6(2019)
• Page Start: 1114
• Page End: 1123
• Publication Date: 2019-03-13
• Subjects: antiepileptic drugs -- drug‐resistant epilepsy -- epilepsy -- outcome -- treatment; Epilepsy -- Periodicals; 616.853
• DOI: 10.1111/epi.14685
• Languages: English
• ISSNs: 0013-9580

Abstract

Summary: Objective: Although many studies have attempted to describe treatment outcomes in patients with drug‐resistant epilepsy, results are often limited by the adoption of nonhomogeneous criteria and different definitions of seizure freedom. We sought to evaluate treatment outcomes with a newly administered antiepileptic drug (AED) in a large population of adults with drug‐resistant focal epilepsy according to the International League Against Epilepsy (ILAE) outcome criteria. Methods: This is a multicenter, observational, prospective study of 1053 patients with focal epilepsy diagnosed as drug‐resistant by the investigators. Patients were assessed at baseline and 6, 12, and 18 months, for up to a maximum of 34 months after introducing another AED into their treatment regimen. Drug resistance status and treatment outcomes were rated according to ILAE criteria by the investigators and by at least two independent members of an external expert panel (EP). Results: A seizure‐free outcome after a newly administered AED according to ILAE criteria ranged from 11.8% after two failed drugs to 2.6% for more than six failures. Significantly fewer patients were rated by the EP as having a "treatment failure" as compared to the judgment of the investigator (46.7% vs 62.9%, P < 0.001), because many more patients were rated as "undetermined outcome" (45.6% vs 27.7%, P < 0.001); 19.3% of the recruited patients were not considered drug‐resistant by the EP. Significance: This study validates the use of ILAE treatment outcome criteria in a real‐life setting, providing validated estimates of seizure freedom in patients with drug‐resistant focal epilepsy in relation to the number of previously failed AEDs. Fewer than one in 10 patients achieved seizure freedom on a newly introduced AED over the study period. Pseudo drug resistance could be identified in one of five cases.