title: PEGylated interferon beta-1a: meeting an unmet medical need in the treatment of relapsing multiple sclerosis.
abstract: Multiple sclerosis is a chronic autoimmune disease of the central nervous system for which a number of disease-modifying therapies are available, including interferon beta (Avonex®, Rebif®, and Betaseron/Betaferon®), glatiramer acetate (Copaxone®), and an anti-VLA4 monoclonal antibody (Tysabri®). Despite the availability and efficacy of these protein and peptide drugs, there remains a significant number of patients who are untreated, including those with relatively mild disease who choose not to initiate therapy, those wary of injections or potential adverse events associated with therapy, and those who have stopped therapy due to perceived lack of efficacy. Since these drugs have side effects that may affect a patient's decision to initiate and to remain on treatment, there is a need to provide a therapy that is safe and efficacious but that requires a reduced dosing frequency and hence a concomitant reduction in the frequency of side effects. Here we describe the development of a PEGylated form of interferon beta-1a that is currently being tested in a multicenter, randomized, double-blind, parallel-group, placebo-controlled study in relapsing multiple sclerosis patients, with the aim of determining the safety and efficacy of 125 microg administered via the subcutaneous route every 2 or 4 weeks.
authors.affiliation: BiogenIdec Inc., Cambridge, Massachusetts 02142, USA. darren.baker@biogenidec.com
authors.forename: Darren P
authors.initials: DP
authors.lastname: Baker
authors.forename: Robert Blake
authors.initials: RB
authors.lastname: Pepinsky
authors.forename: Margot
authors.initials: M
authors.lastname: Brickelmaier
authors.forename: Robert S
authors.initials: RS
authors.lastname: Gronke
authors.forename: Xiao
authors.initials: X
authors.lastname: Hu
authors.forename: Kenneth
authors.initials: K
authors.lastname: Olivier
authors.forename: Michaela
authors.initials: M
authors.lastname: Lerner
authors.forename: Larisa
authors.initials: L
authors.lastname: Miller
authors.forename: Mary
authors.initials: M
authors.lastname: Crossman
authors.forename: Ivan
authors.initials: I
authors.lastname: Nestorov
authors.forename: Meena
authors.initials: M
authors.lastname: Subramanyam
authors.forename: Stacy
authors.initials: S
authors.lastname: Hitchman
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Glick
authors.forename: Sandra
authors.initials: S
authors.lastname: Richman
authors.forename: Shifang
authors.initials: S
authors.lastname: Liu
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhu
authors.forename: Michael A
authors.initials: MA
authors.lastname: Panzara
authors.forename: Gudarz
authors.initials: G
authors.lastname: Davar
mesh_terms: D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use*; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000276:immunology; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000737:chemistry*; D016032:Randomized Controlled Trials as Topic; D012008:Recurrence
chemical_list: D011092:Polyethylene Glycols; D016899:Interferon-beta; D000068556:Interferon beta-1a