Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy

Marco Mula, Gaetano Zaccara, Carlo Andrea Galimberti, Bruno Ferrò, Maria Paola Canevini, Addolorata Mascia, Oriano Mecarelli, Roberto Michelucci, Laura Rosa Pisani, Luigi Maria Specchio, Salvatore Striano, Emilio Perucca

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)1114-23
Number of pages10
JournalEpilepsia
Volume 60
Issue number6
DOIs
Publication statusPublished - Jun 13 2019

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Partial Epilepsy
Epilepsy
Anticonvulsants
Seizures
Research Personnel
Drug Resistance
Pharmaceutical Preparations
Drug Resistant Epilepsy
Treatment Failure
Observational Studies
Prospective Studies

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Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy. / 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.

In: Epilepsia, Vol. 60, No. 6, 13.06.2019, p. 1114-23.

Research output: Contribution to journalArticle

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. / Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy. In: Epilepsia. 2019 ; Vol. 60, No. 6. pp. 1114-23.
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T1 - Validated outcome of treatment changes according to International League Against Epilepsy criteria in adults with drug-resistant focal epilepsy

AU - Mula, Marco

AU - Zaccara, Gaetano

AU - Galimberti, Carlo Andrea

AU - Ferrò, Bruno

AU - Canevini, Maria Paola

AU - Mascia, Addolorata

AU - Mecarelli, Oriano

AU - Michelucci, Roberto

AU - Pisani, Laura Rosa

AU - Specchio, Luigi Maria

AU - Striano, Salvatore

AU - Perucca, Emilio

N1 - © 2019 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.

PY - 2019/6/13

Y1 - 2019/6/13

N2 - 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.

AB - 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.

U2 - 10.1111/epi.14685

DO - 10.1111/epi.14685

M3 - Article

VL - 60

SP - 1114

EP - 1123

JO - Epilepsia

JF - Epilepsia

SN - 0013-9580

IS - 6

ER -