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. 2024 Mar;271(3):1150-1159.
doi: 10.1007/s00415-023-12137-8. Epub 2023 Dec 22.

Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry

Pietro Iaffaldano  1 , Giuseppe Lucisano  1   2 , Tommaso Guerra  1 , Francesco Patti  3   4 , Eleonora Cocco  5 , Giovanna De Luca  6 , Vincenzo Brescia Morra  7 , Carlo Pozzilli  8 , Mauro Zaffaroni  9 , Diana Ferraro  10 , Claudio Gasperini  11 , Giuseppe Salemi  12 , Roberto Bergamaschi  13 , Giacomo Lus  14 , Matilde Inglese  15   16 , Silvia Romano  17 , Paolo Bellantonio  18 , Elisabetta Di Monte  19 , Giorgia Teresa Maniscalco  20 , Antonella Conte  21   22 , Alessandra Lugaresi  23   24 , Marika Vianello  25 , Valentina Liliana Adriana Torri Clerici  26 , Alessia Di Sapio  27 , Ilaria Pesci  28 , Franco Granella  29 , Rocco Totaro  30 , Girolama Alessandra Marfia  31 , Maura Chiara Danni  32 , Paola Cavalla  33 , Paola Valentino  34 , Umberto Aguglia  35 , Sara Montepietra  36 , Elisabetta Ferraro  37 , Alessandra Protti  38 , Daniele Spitaleri  39 , Carlo Avolio  40 , Milena De Riz  41 , Davide Maimone  42 , Guido Cavaletti  43 , Paola Gazzola  44 , Gioacchino Tedeschi  45 , Maria Sessa  46 , Marco Rovaris  47 , Franco Di Palma  48 , Maurizia Gatto  49 , Daniela Cargnelutti  50 , Francesca De Robertis  51 , Francesco Ottavio Logullo  52 , Augusto Rini  53 , Giuseppe Meucci  54 , Bonaventura Ardito  55 , Paola Banfi  56 , Davide Nasuelli  57 , Damiano Paolicelli  1 , Maria Assunta Rocca  58 , Emilio Portaccio  59 , Clara Grazia Chisari  3   4 , Giuseppe Fenu  5 , Marco Onofrj  6 , Antonio Carotenuto  7 , Serena Ruggieri  8 , Carla Tortorella  11 , Paolo Ragonese  12 , Mihaela Nica  60 , Maria Pia Amato  59   61 , Massimo Filippi  62 , Maria Trojano  63 ; Italian MS Register
Affiliations

Evaluation of drivers of treatment switch in relapsing multiple sclerosis: a study from the Italian MS Registry

Pietro Iaffaldano et al. J Neurol. 2024 Mar.

Abstract

Background: Active relapsing-remitting (RR) and secondary progressive (SP) multiple sclerosis (MS) are currently defined as "relapsing MS" (RMS). The aim of this cross-sectional study was to assess drivers of treatment switches due to clinical relapses in a population of RMS patients collected in the Italian MS and Related Disorders Register (I-MS&RD).

Methods: RRMS and SPMS patients with at least one relapse in a time window of 2 years before of data extraction were defined as RMS. Factors associated with disease-modifying therapy (DMT) switching due to clinical activity were assessed through multivariable logistic regression models in which treatment exposure was included as the last recorded DMT and the last DMT's class [moderate-efficacy (ME), high-efficacy (HE) DMTs and anti-CD20 drugs].

Results: A cohort of 4739 RMS patients (4161 RRMS, 578 SPMS) was extracted from the I-MS&RD. A total of 2694 patients switching DMTs due to relapses were identified. Switchers were significantly (p < 0.0001) younger, less disabled, more frequently affected by an RR disease course in comparison to non-switcher patients. The multivariable logistic regression models showed that Alemtuzumab (OR 0.08, 95% CI 0.02-0.37), Natalizumab (0.48, 0.30-0.76), Ocrelizumab (0.1, 0.02-0.45) and Rituximab (0.23, 0.06-0.82) exposure was a protective factor against treatment switch due to relapses. Moreover, the use of HE DMTs (0.43, 0.31-0.59), especially anti-CD20 drugs (0.14, 0.05-0.37), resulted to be a protective factor against treatment switch due to relapses in comparison with ME DMTs.

Conclusions: More than 50% of RMS switched therapy due to disease activity. HE DMTs, especially anti-CD20 drugs, significantly reduce the risk of treatment switch.

Keywords: Disease activity; Disease-modifying therapies; Multiple sclerosis; Treatment switch.

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References

    1. Filippi M, Danesi R, Derfuss T et al (2022) Early and unrestricted access to high-efficacy disease-modifying therapies: a consensus to optimize benefits for people living with multiple sclerosis. J Neurol 269(3):1670–1677. https://doi.org/10.1007/s00415-021-10836-8 - DOI - PubMed
    1. European Medicines Agency. Guideline on clinical investigation of medicinal products for the treatment of Multiple Sclerosis. EMA/CHMP/771815/2011, https://www.ema.europa.eu/en/documents/scientific-guideline/guidelinecli...
    1. Bayas A, Christ M, Faissner S et al (2023) Disease-modifying therapies for relapsing/active secondary progressive multiple sclerosis—a review of population-specific evidence from randomized clinical trials. Ther Adv Neurol Disord. https://doi.org/10.1177/17562864221146836 . (Published 2023 Jan 24) - DOI - PubMed - PMC
    1. Gross RH, Corboy JR (2019) Monitoring, switching, and stopping multiple sclerosis disease-modifying therapies [published correction appears in Continuum (Minneap Minn). 2019 Aug;25(4):1175]. Continuum (Minneap Minn). 25(3):715–735. https://doi.org/10.1212/CON.00000000000007383 - DOI - PubMed
    1. Ziemssen T, Derfuss T, de Stefano N et al (2016) Optimizing treatment success in multiple sclerosis. J Neurol 263(6):1053–1065. https://doi.org/10.1007/s00415-015-7986-y - DOI - PubMed

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