title: Interferon beta-1b and secondary progressive multiple sclerosis: licence extension. Useful, but further assessment required.
abstract: (1) Interferon beta-1b is now licensed to treat patients with secondary progressive multiple sclerosis.  (2) The clinical file that we compiled on this indication, includes a double-blind placebo-controlled trial in which 718 patients were treated for 2-3 years.  The trial is methodologically sound.  (3) In this trial, interferon beta-1b, at the only dose tested (8 MIU every two days by the subcutaneous route), significantly reduced the progression of the disability linked to the disease.  After 2-3 years of treatment the percentage of patients confined to a wheelchair was, in absolute values, 16.7% in the interferon beta-1b group and 24.6% in the placebo group.  (4) In this trial the adverse effects linked to interferon beta-1b were already known, i.e. mainly a 'flu-like syndrome at the outset of treatment, and reactions at the injection site.  (5) More than a quarter of patients on interferon beta-1b had neutralising antibodies against interferon beta-1b.  More follow-up is needed to determine the possible impact of these antibodies on treatment efficacy and on the possible risk of autoimmune diseases.  (6) Treatment with interferon beta-1b is still costly.
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000293:Adolescent; D000328:Adult; D000937:Antigen-Antibody Reactions; D002986:Clinical Trials as Topic; D017277:Drug Approval; D005602:France; D006801:Humans; D016899:Interferon-beta / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008875:Middle Aged; D020528:Multiple Sclerosis, Chronic Progressive / Q000188:drug therapy* / Q000276:immunology; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D016899:Interferon-beta