Kappos, L and Polman, C and Pozzilli, C and Thompson, A and Dahlke, F and Knight, R and Hern, J and Coleman, R and Gerrie, L and Cooper, G and Moore, J and Boringa, J and van Oosten, B and Ronner, H and Schrijver, H and Truyen, L and Montalban, J and Rio, J and Tintore, M and Jacas, C and Marzo, E and Lechner-Scott, J and Huber, S and Lienert, C and Brunnschweiler, H and Hawkins, S and Droogan, A and McDonnell, G and Duddy, M and McKinstry, S and Altenkirch, H and Baum, K and Einhaupl, K and Marx, P and Poewe, W and Walter, G and Akman, H and Brockmeier, B and Scherer, P and Zschenderlein, R and Schmierer, K and Gelderblom, H and Hartmann, A and Stapf, C and Luschow, A and Mackert, B and Schumacher, H and Masuhr, F and Hempel, T and Zimmermann, R and Munch, M and Francis, D and Heafield, M and Al-Memar, A and Winer, J and Chong, M and Brochet, B and Gayou, A and Auriacombe, S and Dousset, V and Wiles, C and Thomas, F and Pickersgill, T and Hinds, N and Dawson, K and Hughes, T and Hutchinson, M and Murphy, R and Redmond, J and Webb, S and Stoll, G and Jander, S and Hagemann, G and Koller, H and Hanemann, C and Kolmel, H and Reichel, D and Petereit, K and Thieme, A and Khatami, A and Neumann, M and Amaducci, L and Massacesi, L and Siracusa, G and Amato, M and Bartolozzi, L and Repice, A and Minderhoud, J and De Keyser, J and Zorgdrager, A and Zwanikken, C and Poser, S and Polak, T and Gunther, A and Bitsch, A and Borner, T and Weber, F and Wikstrom, J and Farkkila, M and Majuri, H and Sumelahti, M and Telakivi, T and Fredrikson, S and Martin, C and Miller, D and O'Riordan, J and Brex, P and Kapoor, R and Werring, D and Confavreux, C and Brunet, P and Hannoun, D and Brudon, F and Moreau, T and Blanc, S and D'Hooghe, M and Jacobs, K and Lissoir, F and Demonty, L and Comi, G and Colombo, B and Rossi, P and Rodegher, M and Santuccio, G and Martinelli, F and Hohlfeld, R and Walther, E and Goebels, N and Dang, T and Lindert, R and Voltz, R and Cartlidge, N and Bates, D and Moran, G and Pandit, L and Westwood, M and Haller, P and Sommer, J and Bitter, J and Suss, F and Mellies, J and Mucha, P and Lyon-Caen, O and Degos, JD and Roullet, E and Lubetzki, C and Creange, A and Tourbah, A and Pez, D and Lecanuet, P and Nicolt, P and Edan, G and Belliard, S and De Marco, O and Cahagne, V and De Burghgraeve, V and Brunet, I and Fieschi, C and Millefiorini, E and Gasperini, C and Buttinelli, C and Frontini, M and Howell, S and Hadjivassiliou, M and Gibson, A and Graham, A and Harkness, K and Lawden, M and Clanet, M and Wauban, E and Azais-Vuillemin, C and Lau, GKK and Louis, C and Panelius, M and Ruutiainen, J and Eralinna, J and Soilu-Hanninen, M and Gold, R and Hartung, HP and Jung, S and Bayas, A and Flachenecker, P and Weilbach, F and Archelos, J and Kollegger, H and Vass, K and Asenbaum, S and Chatsakos, T and Beckmann, K and Ghazi, M and Wagner, K and Miltenburger, C and McFarland, H and Petkau, J and Sabouraud, O and Toyka, K and Eur Study Grp Interferon Beta-1b Sec, (1998) Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis. LANCET , 352 (9139) 1491 - 1497.
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Abstract
Background The beneficial effects of interferon beta have only been shown for patients in the relapsing-remitting phase of multiple sclerosis (MS). The role of interferon beta in the treatment of patients who are in the secondary progressive phase of the disease (SP-MS), and for whom no effective drug treatment is available, has not been assessed.Methods In this multicentre, double-masked, randomised, placebo-controlled trial, outpatients with SP-MS having scores of 3.0-6.5 on the Expanded Disability Status Scale (EDSS) received either 8 million IU interferon beta-1b every other day subcutaneously, or placebo, for up to 3 years. The primary outcome was the time to confirmed progression in disability as measured by a 1.0 point increase on the EDSS, sustained for at least 3 months, or a 0.5 point increase if the baseline EDSS was 6.0 or 6.5, A prospectively planned interim analysis of safety and efficacy of the intention-to-treat population was done after all patients had been in the study for at least 2 years.Findings 358 patients with SP-MS were allocated placebo and 360 were allocated interferon beta-1b; 57 patients (31 placebo, 26 interferon beta-1b) were lost to follow-up. There was a highly significant difference in time to confirmed progression of disability in favour of interferon beta-1b (p = 0.0008). Interferon beta-1b delayed progression for 9-12 months in a study period of 2-3 years. The odds ratio for confirmed progression was 0.65 (95% CI 0.52-0.83). This beneficial effect was seen in patients with superimposed relapses and in patients who had only progressive deterioration without relapses. Positive results were also obtained regarding time to becoming wheelchair-bound, relapse rate and severity, number of steroid treatments and hospital admissions, as well as on magnetic resonance imaging variables. The drug was safe and side effects were in line with previous experience with interferon beta-1b. The study was stopped after the interim results gave clear evidence of efficacy. interpretation Treatment with interferon beta-1b delays sustained neurological deterioration in patients with SP-MS.Interferon beta-1b is the first treatment to show a therapeutic effect in patients with SP-MS.
| Type: | Article |
|---|---|
| Title: | Placebo-controlled multicentre randomised trial of interferon beta-1b in treatment of secondary progressive multiple sclerosis |
| Keywords: | STATUS SCALE EDSS, IMPAIRMENT |
| UCL classification: | UCL > School of Life and Medical Sciences > Faculty of Brain Sciences > Institute of Neurology |
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