title: Characterization of MRI response to treatment with interferon beta-1b: contrast-enhancing MRI lesion frequency as a primary outcome measure.
abstract: MRI is a valuable tool to examine the pathophysiology and natural history of multiple sclerosis (MS), and several large multicenter trials have utilized MRI as a secondary outcome measures. We previously examined the effect of interferon beta-1b on contrast-enhancing lesions on MRI using a baseline versus treatment design, and found that on treatment there is a reduction in mean frequency of enhancing lesions over the group. Using an expanded number of patients and the same trial design, we examined the individual response to treatment more extensively. We find that the effect seen previously is still present, and that there is heterogeneity in the amount of decrease in contrast-enhancing lesions. This expanded number of patients and trial design allows for the discussion of new criteria for individual response to treatment, which are applied in the current trial. These approaches may be useful in the examination, early testing, and comparison of experimental therapeutic agents in MS as well as in the characterization of patients who do or do not have a response seen on MRI.
authors.affiliation: Department of Neurology, Mayo Clinic Scottsdale, AZ, USA.
authors.forename: L A
authors.initials: LA
authors.lastname: Stone
authors.forename: J A
authors.initials: JA
authors.lastname: Frank
authors.forename: P S
authors.initials: PS
authors.lastname: Albert
authors.forename: C N
authors.initials: CN
authors.lastname: Bash
authors.forename: P A
authors.initials: PA
authors.lastname: Calabresi
authors.forename: H
authors.initials: H
authors.lastname: Maloni
authors.forename: H F
authors.initials: HF
authors.lastname: McFarland
mesh_terms: D000276:Adjuvants, Immunologic / Q000494:pharmacology / Q000627:therapeutic use*; D000328:Adult; D001812:Blood-Brain Barrier / Q000187:drug effects; D001921:Brain / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D019786:Gadolinium DTPA; D006801:Humans; D007279:Injections, Subcutaneous; D000068556:Interferon beta-1a; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000494:pharmacology / Q000627:therapeutic use*; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000473:pathology / Q000628:therapy*; D009942:Organometallic Compounds; D004369:Pentetic Acid / Q000031:analogs & derivatives; D011994:Recombinant Proteins / Q000494:pharmacology / Q000627:therapeutic use*; D012646:Self Administration; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; D009942:Organometallic Compounds; D011994:Recombinant Proteins; D000068576:Interferon beta-1b; D016899:Interferon-beta; D004369:Pentetic Acid; D019786:Gadolinium DTPA; D000068556:Interferon beta-1a