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 journalArticle

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

Fingerprint

interferon-beta
Relapsing-Remitting Multiple Sclerosis
Interferon-beta
Azathioprine
sclerosis
interferons
Interferons
relapse
Recurrence
lesions (animal)
Magnetic resonance imaging
Multiple Sclerosis
confidence interval
Brain
Confidence Intervals
brain

ASJC Scopus subject areas

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

Cite this

Massacesi, L., Tramacere, I., Amoroso, S., Battaglia, M. A., Benedetti, M. D., Filippini, G., ... Milanese, C. (2014). Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: A multicentre randomized non-inferiority trial. PLoS One, 9(11), [0113371]. https://doi.org/10.1371/journal.pone.0113371

Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis : A multicentre randomized non-inferiority trial. / Massacesi, Luca; Tramacere, Irene; Amoroso, Salvatore; Battaglia, Mario A.; Benedetti, Maria Donata; Filippini, Graziella; La Mantia, Loredana; Repice, Anna; Solari, Alessandra; Tedeschi, Gioacchino; Milanese, Clara.

In: PLoS One, Vol. 9, No. 11, 0113371, 17.11.2014.

Research output: Contribution to journalArticle

Massacesi, L, Tramacere, I, Amoroso, S, Battaglia, MA, Benedetti, MD, Filippini, G, La Mantia, L, Repice, A, Solari, A, Tedeschi, G & Milanese, C 2014, 'Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: A multicentre randomized non-inferiority trial', PLoS One, vol. 9, no. 11, 0113371. https://doi.org/10.1371/journal.pone.0113371
Massacesi, Luca ; Tramacere, Irene ; Amoroso, Salvatore ; Battaglia, Mario A. ; Benedetti, Maria Donata ; Filippini, Graziella ; La Mantia, Loredana ; Repice, Anna ; Solari, Alessandra ; Tedeschi, Gioacchino ; Milanese, Clara. / Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis : A multicentre randomized non-inferiority trial. In: PLoS One. 2014 ; Vol. 9, No. 11.
@article{1646b9da29314325a1381344d93ea7b4,
title = "Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis: A multicentre randomized non-inferiority trial",
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",
author = "Luca Massacesi and Irene Tramacere and Salvatore Amoroso and Battaglia, {Mario A.} and Benedetti, {Maria Donata} and Graziella Filippini and {La Mantia}, Loredana and Anna Repice and Alessandra Solari and Gioacchino Tedeschi and Clara Milanese",
year = "2014",
month = "11",
day = "17",
doi = "10.1371/journal.pone.0113371",
language = "English",
volume = "9",
journal = "PLoS One",
issn = "1932-6203",
publisher = "Public Library of Science",
number = "11",

}

TY - JOUR

T1 - Azathioprine versus beta interferons for relapsing-remitting multiple sclerosis

T2 - A multicentre randomized non-inferiority trial

AU - Massacesi, Luca

AU - Tramacere, Irene

AU - Amoroso, Salvatore

AU - Battaglia, Mario A.

AU - Benedetti, Maria Donata

AU - Filippini, Graziella

AU - La Mantia, Loredana

AU - Repice, Anna

AU - Solari, Alessandra

AU - Tedeschi, Gioacchino

AU - Milanese, Clara

PY - 2014/11/17

Y1 - 2014/11/17

N2 - 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

AB - 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

UR - http://www.scopus.com/inward/record.url?scp=84912137155&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84912137155&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0113371

DO - 10.1371/journal.pone.0113371

M3 - Article

C2 - 25402490

AN - SCOPUS:84912137155

VL - 9

JO - PLoS One

JF - PLoS One

SN - 1932-6203

IS - 11

M1 - 0113371

ER -