A single-center, randomized, double-blind, placebo-controlled study of interferon beta-1b on primary progressive and transitional multiple sclerosis
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Tipus de documentArticle
Data publicació2009-10
Condicions d'accésAccés restringit per política de l'editorial
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Abstract
Inflammation and neurodegeneration may have differential impacts on disease evolution in the different forms of multiple
sclerosis. However, a beneficial effect of immunomodulatory drugs should not be ruled out in primary progressive
multiple sclerosis. Our aim is to investigate the safety and efficacy of interferon beta-1b in primary progressive multiple
sclerosis. We conducted a double-blind, stratified, randomized, parallel group, phase II pilot study where patients with
primary progressive multiple sclerosis or ‘transitional’ forms of multiple sclerosis received interferon beta-1b at doses of
8 MIU or placebo for 24 months. The main objective of the study was to investigate the safety and tolerability of
interferon beta-1b. The primary efficacy variable was the time to neurological deterioration (Expanded Disability Status
Scale) confirmed at 3 months. Seventy-three patients were included and three dropped out the study. More patients in
the treatment arm had at least one related adverse event (94.4% versus 45.9%; p<0.001); no other significant differences
in safety endpoints were observed. Time to neurological deterioration was not different between trial arms (log-rank
test, p¼0.3135). Statistically significant differences favoring treatment were observed for the Multiple Sclerosis
Functional Composite score at several timepoints, T1 and T2 lesion volume changes at 12 and 24 months, mean
number of active lesions and proportion of patients with active lesions at 24 months. We conclude that interferon
beta-1b is safe and well tolerated in patients with primary progressive multiple sclerosis and transitional multiple
sclerosis. Positive effects of interferon beta on secondary clinical and magnetic resonance imaging outcomes were
observed, but a beneficial effect on Expanded Disability Status Scale progression was not demonstrated.
CitacióMontalban, X. [et al.]. A single-center, randomized, double-blind, placebo-controlled study of interferon beta-1b on primary progressive and transitional multiple sclerosis. "Multiple sclerosis", Octubre 2009, vol. 15, núm. 10, p. 1195-1205.
ISSN1352-4585
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