| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
From the University of Basel (L.K.), Basel, Switzerland; University of British Columbia (A.T., D.L.), Vancouver, Canada; University of Nottingham (C.C.), Nottingham, UK; University of Turku (J.-P.E.), Turku, Finland; Serono International S.A. (F.F., B.S.), Geneva, Switzerland; Multiple Sclerosis Centre Nijmegen (P.J.), Nijmegen, The Netherlands; University of Sydney (J.P.), Sydney, Australia; Lund University Hospital (M.S.-W.), Lund, Sweden; UCL Cliniques Universitaires Saint-Luc (C.S.), Brussels, Belgium; and Vrije Universiteit Medical Center (B.U.), Amsterdam, The Netherlands
Address correspondence and reprint requests to Dr. Ludwig Kappos, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland; e-mail: lkappos{at}uhbs.ch
Objective: To conduct systematic long-term follow-up (LTFU) of patients in the Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis (PRISMS) study to provide up to 8 years of safety, clinical and MRI outcomes on subcutaneous (SC) interferon (IFN) ß-1a in relapsing-remitting multiple sclerosis (RRMS).
Methods: The original cohort of 560 patients was randomized to IFNß-1a, 44 or 22 µg three times weekly (TIW) or to placebo; after 2 years, patients on placebo were rerandomized to active treatment and the blinded study continued for a further 4 years. The LTFU visit was scheduled 7 to 8 years after baseline.
Results: LTFU was attended by 68.2% of the original PRISMS study cohort (382/560 patients). 72.0% (275/382) were still receiving IFNß-1a SC TIW. Patients originally randomized to IFNß-1a 44 µg SC TIW showed lower Expanded Disability Status Scale progression, relapse rate and T2 burden of disease up to 8 years compared with those in the late treatment group. Brain parenchymal volume did not show differences by treatment group. Overall, 19.7% of patients progressed to secondary progressive MS between baseline and LTFU (75/381). No new safety concerns were identified and treatment was generally well tolerated.
Conclusions: Despite the limitations inherent in any long-term study (for example, potential differences between returning and nonreturning patients), these results indicate that patients with relapsing-remitting multiple sclerosis can experience sustained benefit over many years from early interferon ß-1a subcutaneous therapy three times weekly compared with patients whose treatment is delayed. This effect was more apparent in the patients receiving the higher dose.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the September 26 issue to find the title link for this article.
Editorial, see page 930
Disclosure: L.K. has participated and is currently participating as principal investigator, member, or chair of planning and steering committees or advisory boards in corporate-sponsored clinical trials in MS. The sponsoring pharmaceutical companies for these trials include Biogen Idec, GlaxoSmithKline, Novartis, Sanofi Aventis, Schering, Serono (all more than US$10,000 per year); furthermore Abbott, Bayer, Bayhill, Berlex, Boehringer Ingelheim, Bristol-Myers Squibb, Centocor, Eisai, Elan, Genzyme, Neurocrine, Roche, Teva, UCB, Wyeth, and others. L.K. has also lectured at medical conferences or in public on various aspects of the diagnosis and management of MS and other neurologic diseases. In many cases, these talks have been sponsored by nonrestricted educational grants from one or another of the above listed companies. Honoraria and other payments for all above-mentioned activities have been exclusively used for funding of research at L.K.’s department. Research and the clinical operations (nursing and patient care services) of the Multiple Sclerosis Clinic and Research Centre at the University Hospital Basel, led by L.K. have been supported by nonrestricted grants from one or more of these companies. A.T. has received honoraria from Serono. C.C. has received honoraria and travel grants for conferences and research support from Serono, TEVA, Biogen Idec, Schering, Cephalon, Bayer, and GlaxoSmithKline. J.-P.E. has no disclosures associated with this paper. F.F. was hired as a statistical consultant to Serono International S.A. P.J. has received no financial support from, or equity positions in, manufacturers of drugs or products associated with this study. J.P. has nothing to disclose regarding financial support from Serono. M.S.-W. has received reimbursement from many companies, including Serono, for travel expenses to scientific meetings. C.S. has received honoraria from Serono. B.S. is an employee of Serono International S.A. and holds equity in the company. B.U. has received personal compensation for activities related to Serono-sponsored clinical trials. D.L. is Director of the UBC MS/MRI Research Group, which has been contracted to perform central analysis of MRI scans for therapeutic trials with Angiotech, Bayer, Berlex-Schering, Bio-MS, Centocor, Hoffmann-LaRoche, Schering-Plough, Teva Neurosciences, Sanofi-Aventis, Serono, Transition Therapeutics.
Received April 28, 2005. Accepted in final form June 6, 2006.
Related Articles
Neurology 2006 67: 928-929.
Neurology 2006 67: 930-931.
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
