PML risk is the main factor driving the choice of discontinuing natalizumab in a large multiple sclerosis population: results from an Italian multicenter retrospective study

Clara G Chisari, Giancarlo Comi, Massimo Filippi, Damiano Paolicelli, Pietro Iaffaldano, Mauro Zaffaroni, Vincenzo Brescia Morra, Eleonora Cocco, Girolama Alessandra Marfia, Luigi Maria Grimaldi, Matilde Inglese, Simona Bonavita, Alessandra Lugaresi, Giuseppe Salemi, Giovanna De Luca, Salvatore Cottone, Antonella Conte, Patrizia Sola, Umberto Aguglia, Giorgia Teresa ManiscalcoClaudio Gasperini, Maria Teresa Ferrò, Ilaria Pesci, Maria Pia Amato, Marco Rovaris, Claudio Solaro, Giacomo Lus, Davide Maimone, Roberto Bergamaschi, Franco Granella, Alessia Di Sapio, Antonio Bertolotto, Rocco Totaro, Marika Vianello, Paola Cavalla, Paolo Bellantonio, Vito Lepore, Francesco Patti

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). However, patients and physicians may consider discontinuing NTZ therapy due to safety or efficacy issues. The aim of our study was to evaluate the NTZ discontinuation rate and reasons of discontinuation in a large Italian population of RRMS patients.

MATERIALS AND METHODS: The data were extracted from the Italian MS registry in May 2018 and were collected from 51,845 patients in 69 Italian multiple sclerosis centers. MS patients with at least one NTZ infusion in the period between June 1st 2012 to May 15th 2018 were included. Discontinuation rates at each time point were calculated. Reasons for NTZ discontinuation were classified as "lack of efficacy", "progressive multifocal leukoencephalopathy (PML) risk" or "other".

RESULTS: Out of 51,845, 5151 patients, 3019 (58.6%) females, with a mean age of 43.6 ± 10.1 years (median 40), were analyzed. Out of 2037 (39.5%) who discontinued NTZ, a significantly higher percentage suspended NTZ because of PML risk compared to lack of efficacy [1682 (32.7% of 5151) vs 221 (4.3%), p < 0.001]; other reasons were identified for 99 (1.9%) patients. Patients discontinuing treatment were older, had longer disease duration and worse EDSS at the time of NTZ initiation and at last follow-up on NTZ treatment. The JCV index and EDSS at baseline were predictors for stopping therapy (HR 2.94, 95% CI 1.22-4.75; p = 0.02; HR 1.36, 95% CI 1.18-5.41; p = 0.04).

CONCLUSIONS: Roughly 60% of MS patients stayed on NTZ treatment during the observation period. For those patients in whom NTZ discontinuation was required, it was mainly due to PML concerns.

Original languageEnglish
JournalJ. Neurol.
DOIs
Publication statusE-pub ahead of print - Jun 28 2021

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