Extended observations on MS patients treated with IM interferon-beta1a (Avonex): implications for modern MS trials and therapeutics.
Extended observations of the pivotal phase III clinical trial of interferon-beta1a (IFNbeta1a; Avonex, Biogen) in relapsing MS patients revealed that: (1) active treatment significantly slowed the accumulation of physical disability over time, reduced clinical exacerbations and MRI brain lesions; (2) clinical efficacy did not depend on disability endpoints; (3) active treatment benefited multiple MRI measures of brain lesions; (4) cerebral atrophy occurred over 2 years in relatively mildly disabled patients; and (5) Avonex could slow the development of atrophy after the first year of treatment. Data from this study were recently used to design a new outcome measure for MS clinical trials (the Multiple Sclerosis Functional Composite), and was also the basis for two ongoing studies of IFNbeta1a: one in patients with monosymptomatic onset of MS and the other in secondary progressive MS.
Jacobs
L
L
Department of Neurology, State University of New York at Buffalo, Buffalo General Hospital, 100 High Street, Buffalo, NY 14203, USA. ner005@po1.bgh.edu
Rudick
R
R
Simon
J
J
D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000293:Adolescent; D000328:Adult; D004185:Disability Evaluation; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007273:Injections, Intramuscular; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects; D008279:Magnetic Resonance Imaging; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000188:drug therapy* / Q000276:immunology* / Q000473:pathology; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D016899:Interferon-beta; D000068556:Interferon beta-1a