Interferon beta-1b and glatiramer acetate effects on permanent black hole evolution.
Author(s): Filippi M, Rocca MA, Camesasca F, Cook S, O'Connor P, Arnason BG, Kappos L, Goodin D, Jeffery D, Hartung HP, Comi G, Wolinsky JS, Bogumil T, Pohl C, Beckmann K, Sandbrink R, Croze E, Brown C, Desimone TM, Arnold DL, Cutter G, Knappertz V
Affiliation(s): University Hospital San Raffaele, Via Olgettina, 20132 Milan, Italy. email@example.com
Publication date & source: 2011-04-05, Neurology., 76(14):1222-8.
Publication type: Clinical Trial, Phase III; Comparative Study; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
OBJECTIVE: To compare interferon beta-1b (IFNbeta-1b) and glatiramer acetate (GA) on new lesion (NL) (gadolinium-enhancing, new T2) evolution into permanent black holes (PBH)--a marker of irreversible tissue damage--in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS: BEYOND was a large, phase III, clinical trial comparing IFNbeta-1b 250 mug, IFNbeta-1b 500 mug, and GA (2:2:1). Patient scans were reexamined post hoc for PBH in a rater-blinded manner. Two predefined coprimary endpoints compared IFNbeta-1b 250 mug with GA: first, number of PBH per patient at year 2 evolving from year 1 NL, then proportion of year 1 NL evolving into PBH at year 2. IFNbeta-1b 500 mug and GA were compared in an exploratory fashion. RESULTS: Approximately 90% (1,957/2,244) of patients had NL at year 1 with follow-up at year 2. Mean numbers of PBH per patient at year 2 evolving from year 1 NL were lower for IFNbeta-1b 250 mug than GA (0.30 vs 0.43; p = 0.0451). The proportion of NL evolving into PBH was similar (IFNbeta-1b 250 mug vs GA: 21.6% vs 23.5%; p > 0.20). For IFNbeta-1b 500 mug, both the mean PBH number per patient at year 2 evolving from year 1 NL (0.26 vs 0.43; p = 0.0037) and proportion of NL evolving into PBH (16.3% vs 23.5%; p = 0.0409) were lower relative to GA. CONCLUSION: IFNbeta-1b affected PBH development to a similar or better extent than GA. IFNbeta-1b favorably influences an MRI outcome indicative of permanent tissue destruction in the brains of patients with multiple sclerosis. Classification of evidence: This study provides Class III evidence that IFNbeta-1b is associated with a reduction in MRI PBH formation and evolution compared with GA between years 1 and 2 of treatment.