PRISMS-4:: Long-term efficacy of interferon-β-1a in relapsing MS

被引:0
作者
Francis, G
Hughes, R
King, J
Mitchell, P
Joubert, J
McLeod, J
Parker, G
Pollard, J
Sindic, CJM
Duprez, T
Medaer, R
Broeckx, J
Vanroose, E
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
Wikström, J
Salonen, OLM
Panelius, M
Erälinna, J
Sonninen, P
Rieckmann, P
Hahn, D
Flachenecker, P
Hartung, HP
Uitdehaag, B
Bertelsmann, FW
Barkhof, F
Hommes, OR
Jongen, PJH
Van Doorn, PA
Tanghe, HLG
Sandberg-Wollheim, M
Larsson, EM
Lönntoft, M
Sallerfors, S
Kappos, L
Lienert, C
Radü, EW
Chofflon, M
机构
[1] Royal Melbourne Hosp, Melbourne, Vic, Australia
[2] Univ Sydney, Sydney, NSW 2006, Australia
[3] Clin Univ St Luc, B-1200 Brussels, Belgium
[4] Limburgs Univ Centrum, Diepenbeek, Belgium
[5] Univ Hosp Gasthuisberg, Louvain, Belgium
[6] London Hlth Sci Ctr, London, ON, Canada
[7] Ottawa Gen Hosp, Ottawa, ON K1H 8L6, Canada
[8] Univ British Columbia, Vancouver, BC V5Z 1M9, Canada
[9] Univ Helsinki, Cent Hosp, Helsinki, Finland
[10] Turku Univ, Cent Hosp, Turku, Finland
[11] Univ Wurzburg Klinikum, Wurzburg, Germany
[12] Vrije Univ Amsterdam, Acad Ziekenhuis, Amsterdam, Netherlands
[13] Stichting Multiple Sclerose Ctr, Nijmegen, Netherlands
[14] Acad Ziekenhuis Dijkzigu, Rotterdam, Netherlands
[15] Univ Lund Hosp, S-22185 Lund, Sweden
[16] Kantonsspital Basel, Basel, Switzerland
[17] Hop Cantonal Univ Geneva, Geneva, Switzerland
[18] Guys Hosp, Guys Kings & St Thomas Sch Med, Dept Neuroimmunol, London SE1 9RT, England
[19] Atkinson Morleys Hosp, London, England
[20] Royal Victoria Infirm, Newcastle Upon Tyne NE1 4LP, Tyne & Wear, England
[21] Univ Nottingham Hosp, Queens Med Ctr, Nottingham NG7 2UH, England
[22] Radcliffe Infirm NHS Trust, Oxford, England
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中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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.
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页码:1628 / 1636
页数:9
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