Project details


    Profiling treatment choices in MS during two different eras: a real world assessment in the Italian MS Registry


  • Data start Data end
    2017-05-08 2017-10-14

    Giuseppe Lucisano, Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara; Dipartimento di scienze mediche di base, Neuroscienze ed organi di senso, Università degli Studi di Bari, Bari
    Giovanna De Luca, Clinica Neurologica, Università G. D'Annunzio, Policlinico SS Annunziata Chieti
    Vincenzo Brescia Morra, Centro di Cura e Ricerca Clinica per la SM, Dipartimento di Neuroscienze (NSRO), Università Federico II, Napoli
    Francesco Patti, Centro SM, Dipartimento di Scienze Mediche e Chirurgiche e Tecnologie Avanzate, Università degli Studi di Catania, Catania
    Eleonora Cocco Dipartimento di Scienze Mediche e Salute Pubblica, Università di Cagliari, Centro SM, Cagliari
    Giuseppe Salemi, Dipartimento di Biomedicina, Neuroscienze e Diagnostica Avanzata, Università degli Studi di Palermo, Palermo
    Maria Pia Amato, Dipartimento NEUROFARBA, Università degli Studi di Firenze, Firenze
    Mauro Zaffaroni, Angelo Ghezzi, Centro SM di Gallarate, ASST della Valle Olona, Gallarate (VA)
    Elisabetta Di Monte, Unità di Neurologia, Presidio Ospedaliero Madonna delle Grazie, Matera
    Davide Maimone, Centro SM, Neurologia, Azienda Ospedaliera Garibaldi, Catania
    Maurizia Gatto, Centro Malattie Demielinizzanti, Ospedale Generale Regionale F. Miulli, Acquaviva delle Fonti, BA
    Francesca De Robertis, Unità di Neurologia, Ospedale Vito Fazzi, Lecce
    Gianfranco Costantino, Centro SM, Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Foggia, Foggia
    Roberto Bergamaschi, IRCCS Fondazione Mondino, Pavia
    Carlo Avolio, Dipartimento Scienze Mediche e Chirurgiche, Università degli Studi di Foggia, Foggia
    Bonaventura Ardito, Ambulatorio di Neurologia, Ospedale della Murgia Fabio, Altamura, BA
    Carlo Pozzilli, Centro SM, Ospedale S. Andrea, Sapienza Università di Roma, Roma
    Giancarlo Comi, Dipartimento di Neurologia, Centro SM, Istituto Scientifico San Raffaele, Milano


    Introduction and aims
    The treatment options for people with multiple sclerosis (MS) have expanded dramatically during the past 20 years. The objective of these disease-modifying treatments (DMTs) is the prevention of further relapses and accumulation of disability. In the European Union neurologists and patients can currently choose from different licensed DMTs, making it increasingly difficult for patients and their physicians to choose between treatments at disease onset and in case of non-response to treatment.
    The main objectives of this study were: to evaluate the changes in therapeutic approach in 2 different treatment epochs and to compare the clinical efficacy of the different first line choices in treatment-naïve relapsing-remitting (RR)MS patients.

    On 14th December 2016 our research group, on behalf of 18 Italian MS centers, notified to the Italian MS Register the study protocol. Subsequently, on 23rd March 2017 the Scientific Committee of the Italian MS Register granted the approval to this project and the approval of data use.
    By using data obtained from the Italian MS Register we extracted two cohorts of naïve RRMS patients receiving the 1st DMT:
    - 1st cohort: first DMT prescription during the 2 years prior to the marketing of Teriflunomide in Italy (Old Era);
    - 2nd cohort: first DMT prescription during the 12 months after the marketing of Dimethylfumarate in Italy (New Era).
    Predictors of treatment choice have been evaluated by regression models with an unstructured correlation-type matrix to account for the hierarchical nature of the data (patients clustered within geographic area (north, center and south)). The intra-class correlation coefficient (ICC) was calculated to assess the variation in the use of treatment choice among geographic area; a greater impact of the geographic area is shown by higher ICC values. The relapse risk during the course of the first DMT prescribed in the New Era cohort, stratified by the baseline EDSS score (≤3, >3), has been evaluated using a Poisson regression model.
    The first cohort (Old Era) was composed by 1,795 RRMS patients, 422 of whom received Glatiramer Acetate (GA) as first DMT. The presence or lack of comorbidities, the age and the disease duration at the time of the 1st DMT prescription were all factors associated with the first treatment choice when only injectables DMT were available as first line drug. Furthermore, the variation in the use of treatment choice among geographic area as impact of ICC was comprised between 2 and 20%. Interferon Beta was more frequently prescribed as first-line DMT in the south of Italy.
    The second cohort was composed by 1,097 MS patients, 338 of whom with first line Oral DMTs. No significant predictors were associated to the dimethylfumarate choice. Teriflunomide was more significantly prescribed in patients with low rates of comorbidities, who were older and with a longer disease duration than patients who received the injectables or the dymethylfumarate treatment. Variation in the use of oral treatment choice among geographic areas as impact of ICC was 7%.
    The relapse risk during the course of the first DMT prescribed in the New Era cohort was evaluated in two separated models based on the baseline EDSS score. In patients with a baseline EDSS > 3 a higher relapse risk was found in younger patients. In patients with a baseline EDSS ≤ 3 increasing age and disease duration at the treatment start, and choice of dimethylfumarate were associated with a lower risk of relapse. A higher number of relapses before the first DMT prescription and the choice of teriflunomide as first DMT were associated with an increased risk of relapse.

    Our results indicate that in Italy GA was used more frequently in patients older and with more comorbidities than patients treated with IFNB before the introduction of oral first-line DMTs.
    The new first line oral DMTs have been more frequently used in patients without comorbidities in comparison to injectable DMTs. This latter finding was more pronounced in patients treated with teriflunomide. In less-disabled patients (EDSS ≤3) the use of dimethylfumarate was associated with a reduced risk of relapse in comparison to teriflunomide.

    Pubblicazioni e Comunicazioni a Congressi/ Publications and Congress Presentations
    The present work has been presented as Poster at at XLVIII Congresso Nazionale SIN, Napoli 14-17 ottobre 2017


    Poster XLVIII Congresso Nazionale SIN, Napoli 14-17 Ottobre 2017.

Privacy Policy

Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS.
Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109