title: Fingolimod versus intramuscular interferon in patient subgroups from TRANSFORMS.
abstract: In the 12-month phase 3 TRANSFORMS study, fingolimod showed greater efficacy than intramuscular interferon beta (IFNβ)-1a in patients with relapsing-remitting multiple sclerosis (RRMS). This study analyzed fingolimod efficacy compared with IFNβ-1a in patient subgroups from TRANSFORMS. Patients were randomized to receive fingolimod or weekly IM IFNβ-1a for 12 months. Analyses of efficacy included annualized relapse rate (ARR), and magnetic resonance imaging (MRI) measures [gadolinium (Gd)-enhancing T1 lesions, new/newly enlarged (active) T2 lesions, brain volume change]. Subgroups were defined based on demographics, disease characteristics (baseline EDSS score, relapse rate, and MRI parameters), and response to previous therapy. Fingolimod 0.5 mg reduced ARR over 12 months by 32-59 % relative to IFNβ-1a in all subgroups defined by demographic factors or baseline disease characteristics. Fingolimod also reduced the number of new Gd-enhancing lesions, active T2 lesions, and the rate of brain volume loss, versus IFNβ-1a in most (95 %) subgroups. In patients with high disease activity despite IFNβ treatment in the year before study, fingolimod 0.5 mg reduced ARR by 61 % relative to IFNβ-1a. Reductions in lesion counts and brain volume loss also favored fingolimod in these patients. In conclusion, consistently better efficacy was observed for fingolimod compared with IFNβ-1a across different subgroups of patients with RRMS.
authors: Mellen Center U-10, Neurological Institute, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA. cohenj@ccf.org
authors: Jeffrey A
authors: JA
authors: Cohen
authors: Frederik
authors: F
authors: Barkhof
authors: Giancarlo
authors: G
authors: Comi
authors: Guillermo
authors: G
authors: Izquierdo
authors: Bhupendra
authors: B
authors: Khatri
authors: Xavier
authors: X
authors: Montalban
authors: Jean
authors: J
authors: Pelletier
authors: Benjamin
authors: B
authors: Eckert
authors: Dieter A
authors: DA
authors: Häring
authors: Gordon
authors: G
authors: Francis
mesh_terms: D000328:Adult; D000375:Aging / Q000502:physiology; D000704:Analysis of Variance; D001921:Brain / Q000473:pathology; D003627:Data Interpretation, Statistical; D005260:Female; D000068876:Fingolimod Hydrochloride; D006801:Humans; D007091:Image Processing, Computer-Assisted; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000503:physiopathology; D011409:Propylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D012008:Recurrence; D013110:Sphingosine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D011409:Propylene Glycols; D016899:Interferon-beta; D000068876:Fingolimod Hydrochloride; D013110:Sphingosine
references: Lancet Neurol. 2012 May;11(5):420-8
references: 22494956
references: Neurology. 2000 Sep 12;55(5):689-93
references: 10980735
references: J Neurol Neurosurg Psychiatry. 2008 Dec;79(12):1368-74
references: 18535026
references: Eur Neurol. 2008;59(3-4):131-5
references: 18057899
references: Ann Neurol. 1996 Mar;39(3):285-94
references: 8602746
references: N Engl J Med. 2010 Feb 4;362(5):387-401
references: 20089952
references: N Engl J Med. 2000 Sep 28;343(13):898-904
references: 11006365
references: N Engl J Med. 2010 Feb 4;362(5):402-15
references: 20089954
references: N Engl J Med. 2002 Jan 17;346(3):158-64
references: 11796849
references: Ann Neurol. 1999 Aug;46(2):197-206
references: 10443885
references: Lancet Neurol. 2011 Jun;10(6):520-9
references: 21571593
references: Brain. 2003 Apr;126(Pt 4):770-82
references: 12615637
references: Epidemiology. 1990 Jan;1(1):43-6
references: 2081237
references: Acta Neurol Scand. 2006 Jun;113(6):378-86
references: 16674604
references: Mult Scler. 2001 Feb;7(1):23-5
references: 11321189
references: Lancet. 1998 Nov 7;352(9139):1498-504
references: 9820297
references: Brain. 2006 Mar;129(Pt 3):595-605
references: 16415309