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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/2706

Title: PRISMS-4: Long-term efficacy of interferon-beta-1a in relapsing MS
Authors: Francis, G
Hughes, R
King, J
Mitchell, P
Joubert, J
McLeod, J
Parker, G
Pollard, J
Sindic, CJM
Duprez, T
Broeckx, J
Carton, H
Wilms, G
Rice, G
Ebers, G
Lee, DH
Freedman, M
Nelson, R
Rabinovitch, H
Christie, S
Avruch, L.
Oger, J
Paty, DW
Li, D
Wikstrom, J
Salonen, OLM
Panelius, M
Eralinna, J
Sonninen, P
Rieckmann, P
Hahn, D
Flachenecker, P
Hartung, HP
Uitdehaag, B
Bertelsmann, F.
Barkhof, F.
Hommes, OR
Jongen, PJH
Van Doorn, PA
Tanghe, HLG
Sandberg-Wollheim, M
Larsson, EM
Lonntoft, M
Sallerfors, S
Kappos, L
Lienert, C
Radu, EW
Chofflon, M
Roth, S
Castillo, V
Schwieger, AF
Hughes, RAC
Clews, AM
Bingham, JB
Barnes, D.
Clifton, AG
Stoy, N
Bates, D.
Coulthard, A
Blumhardt, LD
Evans, SM
Jaspan, T
Palace, J
Newsom-Davis, JM
Byrne, JV
Quaghebeur, G
Paty, DW
Zhao, GJ
Riddehough, A
Rhodes, B
Issue Date: 2001
Citation: NEUROLOGY, 56(12). p. 1628-1636
Abstract: Background: The PRISMS study demonstrated significant clinical and MRI benefit at 2 years for interferon-beta -1a, 22 and 44 meg thrice weekly (tiw), compared with placebo in relapsing-remitting MS. Years 3 and 4 extension study results are reported. Methods: Patients initially receiving placebo were randomized to blinded interferon-beta -1a, 22 or 44 meg tiw (n = 172; crossover group); others continued blinded treatment with their originally assigned dose, 22 meg (Rx22 group) or 44 meg (Rx44 group) tiw (n = 167 per group). Patients had 3- to 6-month clinical and annual MRI assessments. Results: Relapse rates for 4 years were 1.02 (crossover), 0.80 (Rx22, p < 0.001), and 0.72 (Rx44, p < 0.001); the dose effect approached significance (p = 0.069; risk ratio, 0.88; 95% CI, 0.76-1.01). Crossover groups showed reductions in relapse count, MRI activity, and lesion-burden accumulation with interferon-p-la compared with their placebo period (p < 0.001 both doses). Time to sustained disability progression was prolonged by 18 months in the Rx44 group compared with the crossover group (p = 0.047). Rx22 and Rx44 reduced new T2 lesion number and lesion burden compared with crossover (p < 0.001); Rx44 was superior to Rx22 on several clinical and MRI outcomes. Persistent neutralizing antibodies developed in 14.3% (Rx44) and 23.7% (Rx22) of patients and were associated with reduced efficacy. Conclusions: Clinical and MRI benefit continued for both doses up to 4 years, with evidence of dose response. Outcomes were consistently better for patients treated for 4 years than for patients in crossover groups. Efficacy decreased with neutralizing antibody formation.
Notes: Royal Melbourne Hosp, Melbourne, Vic, Australia. Univ Sydney, Sydney, NSW 2006, Australia. Clin Univ St Luc, B-1200 Brussels, Belgium. Limburg Univ Ctr, Diepenbeek, Belgium. UZ Gasthuisberg, Louvain, Belgium. London Hlth Sci Ctr, London, ON, Canada. Ottawa Gen Hosp, Ottawa, ON K1H 8L6, Canada. Univ British Columbia, Vancouver, BC V5Z 1M9, Canada. Univ Helsinki, Cent Hosp, Helsinki, Finland. Turku Univ, Cent Hosp, Turku, Finland. Univ Wurzburg Klinikum, Wurzburg, Germany. Vrije Univ Amsterdam, Acad Ziekenhuis, Amsterdam, Netherlands. Stichting Multiple Sclerose Ctr, Nijmegen, Netherlands. Acad Ziekenhuis Dijkzigu, Rotterdam, Netherlands. Univ Lund Hosp, S-22185 Lund, Sweden. Kantonsspital Basel, Basel, Switzerland. Hop Cantonal Univ Geneva, Geneva, Switzerland. Guys Hosp, Guys Kings & St Thomas Sch Med, Dept Neuroimmunol, London SE1 9RT, England. Atkinson Morleys Hosp, London, England. Royal Victoria Infirm, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England. Univ Nottingham Hosp, Queens Med Ctr, Nottingham NG7 2UH, England. Radcliffe Infirm NHS Trust, Oxford, England.Francis, G, 15 Ch Mines, CH-1202 Geneva, Switzerland.
URI: http://hdl.handle.net/1942/2706
ISI #: 000169424200005
ISSN: 0028-3878
Category: A1
Type: Journal Contribution
Validation: ecoom, 2002
Appears in Collections: Research publications

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