Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis

Jeffrey A. Cohen, Frederik Barkhof, Giancarlo Comi, Hans Peter Hartung, Bhupendra O. Khatri, Xavier Montalban, Jean Pelletier, Ruggero Capra, Paolo Gallo, Guillermo Izquierdo, Klaus Tiel-Wilck, Ana De Vera, James Jin, Tracy Stites, Stacy Wu, Shreeram Aradhye, Ludwig Kappos

Research output: Contribution to journalArticle

Abstract

Background: Fingolimod (FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis. Methods: In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 μg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months. Results: A total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod - 0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P

Original languageEnglish
Pages (from-to)402-415
Number of pages14
JournalNew England Journal of Medicine
Volume362
Issue number5
DOIs
Publication statusPublished - Feb 4 2010

Fingerprint

Interferons
Multiple Sclerosis
Confidence Intervals
Recurrence
Lysosphingolipid Receptors
Relapsing-Remitting Multiple Sclerosis
Double-Blind Method
Lymph Nodes
Magnetic Resonance Imaging
Lymphocytes
Fingolimod Hydrochloride
Therapeutics

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Cohen, J. A., Barkhof, F., Comi, G., Hartung, H. P., Khatri, B. O., Montalban, X., ... Kappos, L. (2010). Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. New England Journal of Medicine, 362(5), 402-415. https://doi.org/10.1056/NEJMoa0907839

Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. / Cohen, Jeffrey A.; Barkhof, Frederik; Comi, Giancarlo; Hartung, Hans Peter; Khatri, Bhupendra O.; Montalban, Xavier; Pelletier, Jean; Capra, Ruggero; Gallo, Paolo; Izquierdo, Guillermo; Tiel-Wilck, Klaus; De Vera, Ana; Jin, James; Stites, Tracy; Wu, Stacy; Aradhye, Shreeram; Kappos, Ludwig.

In: New England Journal of Medicine, Vol. 362, No. 5, 04.02.2010, p. 402-415.

Research output: Contribution to journalArticle

Cohen, JA, Barkhof, F, Comi, G, Hartung, HP, Khatri, BO, Montalban, X, Pelletier, J, Capra, R, Gallo, P, Izquierdo, G, Tiel-Wilck, K, De Vera, A, Jin, J, Stites, T, Wu, S, Aradhye, S & Kappos, L 2010, 'Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis', New England Journal of Medicine, vol. 362, no. 5, pp. 402-415. https://doi.org/10.1056/NEJMoa0907839
Cohen, Jeffrey A. ; Barkhof, Frederik ; Comi, Giancarlo ; Hartung, Hans Peter ; Khatri, Bhupendra O. ; Montalban, Xavier ; Pelletier, Jean ; Capra, Ruggero ; Gallo, Paolo ; Izquierdo, Guillermo ; Tiel-Wilck, Klaus ; De Vera, Ana ; Jin, James ; Stites, Tracy ; Wu, Stacy ; Aradhye, Shreeram ; Kappos, Ludwig. / Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis. In: New England Journal of Medicine. 2010 ; Vol. 362, No. 5. pp. 402-415.
@article{55aa79e068174969a0c82901ab3633c0,
title = "Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis",
abstract = "Background: Fingolimod (FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis. Methods: In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 μg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months. Results: A total of 1153 patients (89{\%}) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod - 0.20 (95{\%} confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95{\%} CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95{\%} CI, 0.26 to 0.42; P",
author = "Cohen, {Jeffrey A.} and Frederik Barkhof and Giancarlo Comi and Hartung, {Hans Peter} and Khatri, {Bhupendra O.} and Xavier Montalban and Jean Pelletier and Ruggero Capra and Paolo Gallo and Guillermo Izquierdo and Klaus Tiel-Wilck and {De Vera}, Ana and James Jin and Tracy Stites and Stacy Wu and Shreeram Aradhye and Ludwig Kappos",
year = "2010",
month = "2",
day = "4",
doi = "10.1056/NEJMoa0907839",
language = "English",
volume = "362",
pages = "402--415",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "5",

}

TY - JOUR

T1 - Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis

AU - Cohen, Jeffrey A.

AU - Barkhof, Frederik

AU - Comi, Giancarlo

AU - Hartung, Hans Peter

AU - Khatri, Bhupendra O.

AU - Montalban, Xavier

AU - Pelletier, Jean

AU - Capra, Ruggero

AU - Gallo, Paolo

AU - Izquierdo, Guillermo

AU - Tiel-Wilck, Klaus

AU - De Vera, Ana

AU - Jin, James

AU - Stites, Tracy

AU - Wu, Stacy

AU - Aradhye, Shreeram

AU - Kappos, Ludwig

PY - 2010/2/4

Y1 - 2010/2/4

N2 - Background: Fingolimod (FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis. Methods: In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 μg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months. Results: A total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod - 0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P

AB - Background: Fingolimod (FTY720), a sphingosine-1-phosphate-receptor modulator that prevents lymphocyte egress from lymph nodes, showed clinical efficacy and improvement on imaging in a phase 2 study involving patients with multiple sclerosis. Methods: In this 12-month, double-blind, double-dummy study, we randomly assigned 1292 patients with relapsing-remitting multiple sclerosis who had a recent history of at least one relapse to receive either oral fingolimod at a daily dose of either 1.25 or 0.5 mg or intramuscular interferon beta-1a (an established therapy for multiple sclerosis) at a weekly dose of 30 μg. The primary end point was the annualized relapse rate. Key secondary end points were the number of new or enlarged lesions on T2-weighted magnetic resonance imaging (MRI) scans at 12 months and progression of disability that was sustained for at least 3 months. Results: A total of 1153 patients (89%) completed the study. The annualized relapse rate was significantly lower in both groups receiving fingolimod - 0.20 (95% confidence interval [CI], 0.16 to 0.26) in the 1.25-mg group and 0.16 (95% CI, 0.12 to 0.21) in the 0.5-mg group - than in the interferon group (0.33; 95% CI, 0.26 to 0.42; P

UR - http://www.scopus.com/inward/record.url?scp=76149140914&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=76149140914&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa0907839

DO - 10.1056/NEJMoa0907839

M3 - Article

C2 - 20089954

AN - SCOPUS:76149140914

VL - 362

SP - 402

EP - 415

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 5

ER -