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Mult Scler Relat Disord. 2014 May;3(3):355-63. doi: 10.1016/j.msard.2013.11.006. Epub 2013 Dec 12.

Effect of prior treatment status and reasons for discontinuation on the efficacy and safety of fingolimod vs. interferon β-1a intramuscular: Subgroup analyses of the Trial Assessing Injectable Interferon vs. Fingolimod Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS).

Author information

1
The Regional MS Center, Center for Neurological Disorders, Wheaton Franciscan Health Care, 3237 S. 16th Street, Milwaukee, WI 53215, USA. Electronic address: bokhatri@aol.com.
2
CHU La Timone, CRMBM-CNRS 6612, Marseille, France. Electronic address: jean.pelletier@mail.ap-hm.fr.
3
University Hospital, Petersgraben 4, Basel 4031, Switzerland. Electronic address: lkappos@uhbs.ch.
4
Heinrich Heine University, Moorenstr 5, Dusseldorf 40225, Germany. Electronic address: Hans-Peter.Hartung@uniduesseldorf.de.
5
Università Vita-Salute San Raffaele, Milan 20123, Italy. Electronic address: comi.giancarlo@unisr.it.
6
VU Medical Center, P.O. Box 7057, Amsterdam 1007 MB, The Netherlands. Electronic address: f.barkhof@vumc.nl.
7
Novartis Pharma AG, Kirschgarten Site, Basel 4002, Switzerland. Electronic address: philipp.von_rosenstiel@novartis.com.
8
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: Xiangyi.meng@novartis.com.
9
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: augustogrinspan@hotmail.com.
10
Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. Electronic address: ronny.hashmonay@novartis.com.
11
Mellen Center, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, OH 44195, USA. Electronic address: cohenj@ccf.org.

Abstract

BACKGROUND:

Fingolimod demonstrated superior efficacy compared with interferon β-1a intramuscular in relapsing multiple sclerosis. The impact of treatment history on fingolimod efficacy is unknown.

OBJECTIVES:

This post-hoc analysis of phase 3 TRANSFORMS data compared the efficacy and safety of fingolimod and interferon β-1a intramuscular among patient subgroups defined by prior treatment history.

METHODS:

Annualized relapse rate and safety of once-daily oral fingolimod 0.5mg, 1.25mg, or once-weekly interferon β-1a 30μg intramuscular for 12 months were analyzed in 1292 patients with relapsing multiple sclerosis according to prior disease-modifying therapy, reason for prior disease-modifying therapy discontinuation (adverse events or unsatisfactory therapeutic effect), and prior disease-modifying therapy duration.

RESULTS:

Compared with interferon β-1a intramuscular, fingolimod 0.5mg significantly reduced annualized relapse rate in patients who were treatment naive, received prior interferon-β treatment, discontinued prior disease-modifying therapy for unsatisfactory therapeutic effect, or had prior disease-modifying therapy duration of ≥1 year (P≤0.05, all comparisons). Similar trends were observed in patients with prior glatiramer acetate treatment. Significant reductions were also seen with fingolimod 1.25mg for treatment-naive and prior interferon-β-treated patients.

CONCLUSIONS:

This analysis demonstrates superiority of fingolimod over interferon β-1a intramuscular regardless of prior (interferon-β) treatment and prior treatment efficacy and duration. ClinicalTrials.gov identifier: NCT00340834.

KEYWORDS:

Disease-modifying therapy; Fingolimod; Interferon; Multiple sclerosis; Relapse rate; Sphingosine 1-phosphate receptor modulator

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