Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

Emanuele D’Amico, Aurora Zanghì, Marzia Romeo, Eleonora Cocco, Giorgia Teresa Maniscalco, Vincenzo Brescia Morra, Damiano Paolicelli, Giovanna De Luca, Simonetta Galgani, Maria Pia Amato, Giuseppe Salemi, Matilde Inglese, Paolo Agostino Confalonieri, Giacomo Lus, Carlo Avolio, Antonio Gallo, Marika Vianello, Marco Onofrj, Massimo Filippi, Maria TrojanoFrancesco Patti

Research output: Contribution to journalArticlepeer-review


The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p < 0.05) and a lower mean age (36.1 ± 10.9 vs 38.9 ± 11.8, p < 0.001). The event time to first relapse demonstrated a lower risk in the OG (HR = 0.58; CI 95% 0.48–0.72, p < 0.001). However, no differences were found between the two groups with respect to the risk of CDP (HR = 0.94; CI 95% 0.76–1.29, p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.

Original languageEnglish
Publication statusPublished - Apr 2021


  • EDSS score
  • injectable DMTs
  • Multiple sclerosis
  • oral DMTs
  • real-world setting

ASJC Scopus subject areas

  • Pharmacology
  • Clinical Neurology
  • Pharmacology (medical)


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