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Randomised double-blind placebo-controlled study of interferon -1a in relapsing/remitting multiple sclerosis

, and Källen, Kristina LU (1998) In The Lancet 352. p.504-1498
Abstract
Background Previous trials of interferon 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 -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 -1a 22 g (n=189), or 44 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... (More)
Background Previous trials of interferon 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 -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 -1a 22 g (n=189), or 44 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 -1a than with
placebo (mean number per patient 1·82 for 22 g group,
1·73 for 44 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 g
and 44 g groups respectively, and the proportion of
relapse-free patients was significantly increased (p<0·05).
Interferon -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 -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.
Lancet 1998; 352: 1498–504
See (Less)
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author
publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet
volume
352
pages
504 - 1498
publisher
Elsevier Limited
external identifiers
  • scopus:0345601517
ISSN
1474-547X
DOI
10.1016/S0140-6736(98)03334-0
language
English
LU publication?
no
id
64044459-011e-4bb7-a76d-fe258c06868c
date added to LUP
2017-12-07 16:35:53
date last changed
2018-09-23 04:53:55
@article{64044459-011e-4bb7-a76d-fe258c06868c,
  abstract     = {Background Previous trials of interferon  in multiple<br>
sclerosis (MS) have shown efficacy, but the degree of<br>
clinical benefit remains uncertain, and the optimum dose is<br>
not known. We undertook a double-blind, placebo-controlled<br>
study in relapsing/remitting MS to investigate the effects<br>
of subcutaneous interferon -1a.<br>
Methods 560 patients with Kurtzke expanded disability<br>
status scale (EDSS) scores of 0–5·0, from 22 centres in<br>
nine countries, were randomly assigned subcutaneous<br>
recombinant interferon -1a 22 g (n=189), or 44 g<br>
(n=184), or placebo (n=187) three times a week for<br>
2 years. Neurological examinations were done every<br>
3 months. All patients had MRI twice yearly and 205 had<br>
monthly scans in the first 9 months of treatment. Analysis<br>
was by intention to treat.<br>
Findings Clinical data on 533 (95%) patients were available<br>
at 2 years. The relapse rate was significantly lower at 1 and<br>
2 years with both doses of interferon -1a than with<br>
placebo (mean number per patient 1·82 for 22 g group,<br>
1·73 for 44 g group vs 2·56 for placebo group: risk<br>
reductions 27% [95% CI 14–39] and 33 [21–44]). Time to<br>
first relapse was prolonged by 3 and 5 months in the 22 g<br>
and 44 g groups respectively, and the proportion of<br>
relapse-free patients was significantly increased (p&lt;0·05).<br>
Interferon -1a delayed progression in disability, and<br>
decreased accumulated disability during the study. The<br>
accumulation of burden of disease and number of active<br>
lesions on MRI was lower in both treatment groups than in<br>
the placebo group.<br>
Interpretation Subcutaneous interferon -1a is an effective<br>
treatment for relapsing/remitting MS in terms of relapse<br>
rate, defined disability, and all MRI outcome measures in a<br>
dose-related manner, and it is well tolerated. Longer-term<br>
benefits may become clearer with further follow-up and<br>
investigation.<br>
Lancet 1998; 352: 1498–504<br>
See},
  author       = {,  and Källen, Kristina},
  issn         = {1474-547X},
  language     = {eng},
  month        = {11},
  pages        = {504--1498},
  publisher    = {Elsevier Limited},
  series       = {The Lancet},
  title        = {Randomised double-blind placebo-controlled study of interferon -1a in relapsing/remitting multiple sclerosis},
  url          = {http://dx.doi.org/10.1016/S0140-6736(98)03334-0},
  volume       = {352},
  year         = {1998},
}