BackgroundCognitive impairment (CI) is a prevalent and debilitating manifestation of multiple sclerosis (MS); however, it is not included in the widely used concept of No Evidence of Disease Activity (NEDA-3). We expanded the NEDA-3 concept to NEDA-3 + by encompassing CI assessed through the Symbol Digit Modality Test (SDMT) and evaluated the effect of teriflunomide on NEDA3 + in patients treated in a real-world setting. The value of NEDA-3 + in predicting disability progression was also assessed.MethodsThis 96-weeks observational study enrolled patients already on treatment with teriflunomide for & GE; 24 weeks. The predictiveness of NEDA-3 and NEDA-3 + at 48 weeks on the change in motor disability at 96 weeks was compared through a two-sided McNemar test.ResultsThe full analysis set (n = 128; 38% treatment naive) featured relatively low level of disability (baseline EDSS = 1.97 & PLUSMN; 1.33). NEDA-3 and NEDA-3 + statuses were achieved by 82.8% and 64.8% of patients, respectively at 48 weeks vs. baseline, and by 57.0% and 49.2% of patients, respectively at 96 weeks vs. baseline. All patients except one were free of disability progression at Week 96, and NEDA-3 and NEDA-3 + were equally predictive. Most patients were free of relapse (87.5%), disability progression (94.5%) and new MRI activity (67.2%) comparing 96 weeks with baseline. SDMT scores were stable in patients with baseline score >35 and improved significantly in those with baseline score & LE; 35. Treatment persistence was high (81.0% at Week 96).ConclusionTeriflunomide confirmed its real-world efficacy and was found to have a potentially beneficial effect on cognition.

Effectiveness of teriflunomide on No Evidence of Disease Activity and cognition in relapsing remitting multiple sclerosis: results of the NEDA3PLUS study / Amato, Maria Pia; Bergamaschi, Roberto; Centonze, Diego; Mirabella, Massimiliano; Marfia, Girolama Alessandra; Totaro, Rocco; Lus, Giacomo; Brescia Morra, Vincenzo; Aguglia, Umberto; Comi, Cristoforo; Cavalla, Paola; Zaffaroni, Mauro; Rovaris, Marco; Grimaldi, Luigi Maria; Leoni, Stefania; Malucchi, Simona; Baldi, Eleonora; Romano, Marcello; Falcini, Mario; Perini, Paola; Assetta, Maurizio; Portaccio, Emilio; Sommacal, Sergio; Olivieri, Nunzio; Parodi, Franco; Todaro, Daniele Santo; Grassivaro, Nicoletta; Farina, Alberto; Mondino, Margaret Mary; Filippi, Massimo; Trojano, Maria. - In: JOURNAL OF NEUROLOGY. - ISSN 1432-1459. - ELETTRONICO. - 270:(2023), pp. 0-0. [10.1007/s00415-023-11820-0]

Effectiveness of teriflunomide on No Evidence of Disease Activity and cognition in relapsing remitting multiple sclerosis: results of the NEDA3PLUS study

Amato, Maria Pia;Portaccio, Emilio;Farina, Alberto;
2023

Abstract

BackgroundCognitive impairment (CI) is a prevalent and debilitating manifestation of multiple sclerosis (MS); however, it is not included in the widely used concept of No Evidence of Disease Activity (NEDA-3). We expanded the NEDA-3 concept to NEDA-3 + by encompassing CI assessed through the Symbol Digit Modality Test (SDMT) and evaluated the effect of teriflunomide on NEDA3 + in patients treated in a real-world setting. The value of NEDA-3 + in predicting disability progression was also assessed.MethodsThis 96-weeks observational study enrolled patients already on treatment with teriflunomide for & GE; 24 weeks. The predictiveness of NEDA-3 and NEDA-3 + at 48 weeks on the change in motor disability at 96 weeks was compared through a two-sided McNemar test.ResultsThe full analysis set (n = 128; 38% treatment naive) featured relatively low level of disability (baseline EDSS = 1.97 & PLUSMN; 1.33). NEDA-3 and NEDA-3 + statuses were achieved by 82.8% and 64.8% of patients, respectively at 48 weeks vs. baseline, and by 57.0% and 49.2% of patients, respectively at 96 weeks vs. baseline. All patients except one were free of disability progression at Week 96, and NEDA-3 and NEDA-3 + were equally predictive. Most patients were free of relapse (87.5%), disability progression (94.5%) and new MRI activity (67.2%) comparing 96 weeks with baseline. SDMT scores were stable in patients with baseline score >35 and improved significantly in those with baseline score & LE; 35. Treatment persistence was high (81.0% at Week 96).ConclusionTeriflunomide confirmed its real-world efficacy and was found to have a potentially beneficial effect on cognition.
2023
270
0
0
Goal 3: Good health and well-being
Amato, Maria Pia; Bergamaschi, Roberto; Centonze, Diego; Mirabella, Massimiliano; Marfia, Girolama Alessandra; Totaro, Rocco; Lus, Giacomo; Brescia Mo...espandi
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1356548
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