Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: A multicentre randomized non-inferiority trial

Luca Massacesi, Irene Tramacere, Salvatore Amoroso, Mario A. Battaglia, Maria Donata Benedetti, Graziella Filippini, Loredana La Mantia, Anna Repice, Alessandra Solari, Gioacchino Tedeschi, Clara Milanese

Research output: Contribution to journalArticlepeer-review

Abstract

For almost three decades in many countries azathioprine has been used to treat relapsing-remitting multiple sclerosis. However its efficacy was usually considered marginal and following approval of β interferons for this indication it was no longer recommended as first line treatment, even if presently no conclusive direct β interferon-azathioprine comparison exists. To compare azathioprine efficacy versus the currently available β interferons in relapsing-remitting multiple sclerosis, a multicenter, randomized, controlled, single-blinded, non-inferiority trial was conducted in 30 Italian multiple sclerosis centers. Eligible patients (relapsing-remitting course; ≥2 relapses in the last 2 years) were randomly assigned to azathioprine or β interferons. The primary outcome was annualized relapse rate ratio (RR) over 2 years. Key secondary outcome was number of new brain MRI lesions. Patients (n = 150) were randomized in 2 groups (77 azathioprine, 73 β interferons). At 2 years, clinical evaluation was completed in 127 patients (62 azathioprine, 65 β interferons). Annualized relapse rate was 0.26 (95% Confidence Interval, CI, 0.19-0.37) in the azathioprine and 0.39 (95% CI 0.30-0.51) in the interferon group. Non-inferiority analysis showed that azathioprine was at least as effective as β interferons (relapse RRAZA/IFN 0.67, one-sided 95% CI 0.96; p

Original languageEnglish
Article number0113371
JournalPLoS One
Volume9
Issue number11
DOIs
Publication statusPublished - Nov 17 2014

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Fingerprint Dive into the research topics of 'Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: A multicentre randomized non-inferiority trial'. Together they form a unique fingerprint.

Cite this