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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/3147

Title: Randomised double-blind placebo-controlled study of interferon beta-1a in relapsing/remitting multiple sclerosis
Authors: Ebers, GC
Rice, G
Lesaux, J
Paty, D
Oger, J
Beall, S.
Devonshire, V
Hashimoto, S
Hooge, J
Kastrukoff, L
Krieger, C
Mezei, M
Seland, P
Vorobeychi, G
Morrison, W
Nelson, J
Freedman, MS
Chrisie, S
Nelson, R
Rabinovitch, H
Freedman, C
Hartung, HP
Rieckmann, P
Archelos, J.
Jung, S
Weilbach, F
Flachenecke, P
Sauer, J
Hommes, O
Jongen, P
Brouwer, S
McLeod, J
Pollard, J
Nguti, Rosemary
Sandberg-Wollheim, M
Kallen, K
Nilsson, P
Ekberg, R
Lundgren, A
Jadback, G
Wikstrom, J
Multanen, J
Valjakka, M
Carton, H
Lissoir, F
Declerq, I
Vieren, M
Peeters, E
Dubois, B
Dekeersmaeker, E
Van Herle, A
Hughes, RAC
Sharrack, B
Soudain, S
Panelius, M
Eralinna, J
Soilu-Hanninen, M
Murto, S
Broeckx, J
Blumhardt, LD
Edwards, S
Liu, C
Orpe, V
Barnes, D.
Schwartz, M
Stoy, N
Harraghy, C
Bertelsmann, F.
Uitdehaag, B
Nasseri, K
Chofflon, M
Roth, S
Kappos, L
Huber, S
Bellaiche, Y.
Senn, C
King, J
Jubert, J
Whitten, S
Newsom-Davis, JM
Palace, J
Lee, M
Evangelou, N
Pinto, A
Cavey, A
Sindic, CJM
Monteyne, P.
Verougstraete, D
Van Doorn, PA
Moll, W
Visser, L
Willems, M
Martina, I
Buljevac, D
Loman, L
Bates, D.
Pandit, D
Irving, J
Rhodes, B
Riddehough, A
Zhao, GJ
Wang, X
Cheng, Y
Ammoury, N.
Dupont, F
Galazka, A
Hyde, R
Olson, M
Pernin, MO
Abdul-Ahad, AK
Hommes, O
Noseworthy, J
Borden, E
O'Brien, P
Wolinsky, J
Medaer, Rob
Vanroose, Erwin
Bogaers Anne
Issue Date: 1998
Publisher: LANCET LTD
Citation: LANCET, 352(9139). p. 1498-1504
Abstract: Background Previous trials of interferon beta in multiple sclerosis (MS) have shown efficacy, but the degree of clinical benefit remains uncertain, and the optimum dose is not known. We undertook a double-blind, placebo-controlled study in relapsing/remitting MS to investigate the effects of subcutaneous interferon beta-1a. Methods 560 patients with Kurtzke expanded disability status scale (EDSS) scores of 0-5.0, from 22 centres in nine countries, were randomly assigned subcutaneous recombinant interferon beta-1a 22 mu g (n=189), or 44 mu g (n=184), or placebo (n=187) three times a week for 2 years. Neurological examinations were done every 3 months. All patients had MRI twice yearly and 205 had monthly scans in the first 9 months of treatment. Analysis was by intention to treat. Findings Clinical data on 533 (95%) patients were available at 2 years. The relapse rate was significantly lower at 1 and 2 years with both doses of interferon beta-1a than with placebo (mean number per patient 1.82 for 22 mu g group, 1.73 for 44 mu g group vs 2.56 for placebo group: risk reductions 27% [95% CI 14-39] and 33 [21-44]). Time to first relapse was prolonged by 3 and 5 months in the 22 mu g and 44 mu g groups respectively, and the proportion of relapse-free patients was significantly increased (p < 0.05). Interferon beta-1a delayed progression in disability, and decreased accumulated disability during the study. The accumulation of burden of disease and number of active lesions on MRI was lower in both treatment groups than in the placebo group. Interpretation Subcutaneous interferon beta-1a is an effective treatment for relapsing/remitting MS in terms of relapse rate, defined disability, and all MRI outcome measures in a dose-related manner, and it is well tolerated. Longer-term benefits may become clearer with further follow-up and investigation.
Notes: London Hlth Sci Ctr, Div Neurol, London, ON N6A 5A5, Canada. Univ Western Ontario, Univ Hosp, London, ON N6A 5A5, Canada. Vancouver Hosp, Vancouver, BC, Canada. Univ British Columbia, Vancouver, BC V5Z 1M9, Canada. Ottawa Gen Hosp, Ottawa, ON K1H 8L6, Canada. Univ Wurzburg, Kopfklinikum, Neurol Klin & Poliklin, Wurzburg, Germany. Stichting MS Centrum, Nijmegen, Netherlands. Univ Sydney, Sydney, NSW 2006, Australia. Univ Lund Hosp, S-22185 Lund, Sweden. Univ Helsinki, Cent Hosp, Helsinki, Finland. Catholic Univ Louvain, Hosp Gasthuisberg, B-3000 Louvain, Belgium. Guys Hosp, London SE1 9RT, England. Turku Univ, Cent Hosp, FIN-20520 Turku, Finland. Univ Diepenbeek, Dr Willems Inst, Diepenbeek, Belgium. Univ Hosp, Queens Med Ctr, Nottingham, England. Atkinson Morleys Hosp, London, England. Free Univ Amsterdam Hosp, Amsterdam, Netherlands. Hop Cantonal Univ Geneva, CH-1211 Geneva, Switzerland. Univ Kliniken, Kantonsspital Basel, Basel, Switzerland. Royal Melbourne Hosp, Melbourne, Vic, Australia. Univ Oxford, Radcliffe Infirm, Oxford OX2 6HE, England. Clin Univ St Luc, B-1200 Brussels, Belgium. Acad Ziekenhuis Dijkzigt, Rotterdam, Netherlands. Royal Victoria Infirm, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England. Univ British Columbia, MS MRI Anal Res Grp, Vancouver, BC V5Z 1M9, Canada. Ares Serono Int SA, Geneva, Switzerland.Ebers, GC, London Hlth Sci Ctr, Div Neurol, 339 Windermere Rd, London, ON N6A 5A5, Canada.
URI: http://hdl.handle.net/1942/3147
DOI: 10.1016/S0140-6736(98)03334-0
ISI #: 000076862300007
ISSN: 0140-6736
Type: Journal Contribution
Validation: ecoom, 1999
Appears in Collections: Research publications

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