Comparison of fingolimod with interferon beta-1a in relapsing-remitting multiple sclerosis: a randomised extension of the TRANSFORMS study
Bhupendra Khatri, Frederik Barkhof, Giancarlo Comi, Hans-Peter Hartung, Ludwig Kappos, Xavier Montalban, Jean Pelletier, Tracy Stites, Stacy Wu, Fred Holdbrook, Lixin Zhang-Auberson, Gordon Francis, Jeffrey A Cohen, J Cohen, F Barkhof, G Comi, HP Hartung, B Khatri, X Montalban, J Pelletier Show all
The Lancet Neurology | ELSEVIER SCIENCE INC | Published : 2011
BACKGROUND: In a 12-month phase 3 study in patients with relapsing-remitting multiple sclerosis (RRMS), TRANSFORMS, fingolimod showed greater efficacy on relapse rates and MRI outcomes compared with interferon beta-1a. We had two aims in our extension: to compare year 2 with year 1 in the switched patients to assess the effect of a change from interferon beta-1a to fingolimod, and to compare over 24 months the treatment groups as originally randomised to assess the effect of delaying the start of treatment with fingolimod. METHODS: Patients randomly assigned to receive 0.5 mg or 1.25 mg daily oral fingolimod in the core study continued with the same treatment in our extension; patients who o..View full abstract
The study was funded by Novartis Pharma AG. We thank the patients and investigators who took part in this study. We thank Lee Anne Carroll of Novartis Pharmaceuticals, and Rowena Hughes and Eric Southam of Oxford PharmaGenesis Ltd for editorial assistance, collating the comments of authors and other named contributors, and editing the paper for submission; this editorial help was funded by Novartis Pharma AG.BK (Bayer, Biogen Idec, Caridian, Novartis, Pfizer, Serono, Teva), FB (Bayer Scheming Pharma, Biogen Idec, Janssen Research, Lundbeck, Merck Serono, Novartis, Roche, Sanofi-Aventis, Serono Symposia Foundation, Synthon BV, UCB), GC (Bayer Schering Pharma, Biogen Dompe, Merck Serono International, Novartis, Sanofi-Aventis, Serono Symposa International Foundation, Teva), H-PH (Bayer Healthcare, Biogen Idec, Genzyme, Merck Serono, Novartis, Sanofi-Aventis, Teva), LK (Actellion, Advancell, Allozyne, Barofold, Bayer Health Care Pharamceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, CLC Behring, Elan, Genmab, GeNeuro SA, Genmark, GlaxoSmithKline, Lilly, MediciNova, Merck Serono, Novartis, Novartis Research Foundation, Novonordisk, Peptimmune, Roche Research Foundation, Sanofi-Aventis, Santhera, Roche, Teva, UCB, Wyeth), XM (Bayer, Schering, Biogen Idec, EMD Merck Serono, Genentech, Genzyme, Novartis, Sanofi-Aventis, Teva), JP (Bayer Schering Pharma, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis, Teva), and JC (Biogen Idec, Elan, Lilly, Novartis, Serono, Synthon, Teva) have received payment for serving as consultants or speakers, or they or the institutions they work for have received research support from the companies indicated. FH, TS, SW, and LZ-A are or were employees of Novartis Pharmaceuticals Corporation or Novartis Pharma AG and hold stock or stock options in Novartis.