| Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy.
Mula M1, Zaccara G2, Galimberti CA3, Ferrò B4, Canevini MP5, Mascia A6, Mecarelli O7, Michelucci R8, Pisani LR9, Specchio LM10, Striano S11, Perucca E12.
Author information
1Institute of Medical and Biomedical Education, St George's University of London and Atkinson Morley Regional Neuroscience Centre, St George's University Hospitals National Health Service Foundation Trust, London, UK.2Regional Health Agency of Tuscany, Florence, Italy.3C. Mondino National Neurological Institute, Pavia, Italy.4UCB Pharma, Milan, Italy.5Department of Health Sciences, University of Milan, Epilepsy Center, San Paolo Hospital, Milan, Italy.6IRCCS Neuromed, Pozzilli, Italy.7Department of Human Neurosciences, Sapienza University, Rome, Italy.8IRCCS Istituto delle Scienze Neurologiche di Bologna, UOC Neurologia Ospedale Bellaria, Bologna, Italy.9Neurology Unit, Cutrona-Zodda Hospital, Barcellona Pozzo di Gotto, Italy.10University of Foggia, Foggia, Italy.11Department of Neuroscience and Reproductive and Odontostomatological Sciences, School of Medicine, Federico II Epilepsy Center, University of Naples, Naples, Italy.12Clinical Pharmacology Unit, Department of Internal Medicine and Therapeutics, University of Pavia and Clinical Trial Center, IRCCS Mondino Foundation, Pavia, Italy.
Abstract
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.
www.ncbi.nlm.nih.gov/pubmed/30866058
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