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Golimumab 3-Year Safety Update: An Analysis Of Pooled Data From The Long-Term Extensions Of Randomised, Double-Blind, Placebo-Controlled Trials Conducted In Patients With Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis, Jonathan Kay, Roy Fleischmann, Edward Keystone, Elizabeth C. Hsia, Benjamin Hsu, Michael Mack, Neil Goldstein, Jurgen Braun, Arthur Kavanaugh
Golimumab 3-Year Safety Update: An Analysis Of Pooled Data From The Long-Term Extensions Of Randomised, Double-Blind, Placebo-Controlled Trials Conducted In Patients With Rheumatoid Arthritis, Psoriatic Arthritis Or Ankylosing Spondylitis, Jonathan Kay, Roy Fleischmann, Edward Keystone, Elizabeth C. Hsia, Benjamin Hsu, Michael Mack, Neil Goldstein, Jurgen Braun, Arthur Kavanaugh
Jonathan Kay
OBJECTIVE: To assess pooled golimumab safety up to year 3 of rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) trials. METHODS: Golimumab 50 and 100 mg, administered subcutaneously (SC) every 4 weeks (q4wk), were assessed in patients with active RA (methotrexate-naive, methotrexate-experienced and anti-TNF (tumour necrosis factor)-experienced), PsA or AS, despite conventional therapy. Placebo control continued up to week (wk) 24 (wk 52, methotrexate-naive), with early escape at wk 16 (wk 28, methotrexate-naive); subsequently, all patients received golimumab 50 or 100 mg q4wk. After the blinded controlled period, golimumab doses could be adjusted per investigator discretion. Pooled safety …
Sarilumab For The Treatment Of Ankylosing Spondylitis: Results Of A Phase Ii, Randomised, Double-Blind, Placebo-Controlled Study (Align), Joachim Sieper, Jurgen Braun, Jonathan Kay, Salvatore Badalamenti, Allen R. Radin, Lixia Jiao, Stefano Fiore, Tanya Momtahen, George D. Yancopoulos, Neil Stahl, Robert D. Inman
Sarilumab For The Treatment Of Ankylosing Spondylitis: Results Of A Phase Ii, Randomised, Double-Blind, Placebo-Controlled Study (Align), Joachim Sieper, Jurgen Braun, Jonathan Kay, Salvatore Badalamenti, Allen R. Radin, Lixia Jiao, Stefano Fiore, Tanya Momtahen, George D. Yancopoulos, Neil Stahl, Robert D. Inman
Jonathan Kay
OBJECTIVES: The ALIGN study (NCT01061723) evaluated the efficacy and safety of sarilumab, the first fully human monoclonal antibody against interleukin-6 receptor-alpha (IL-6Ralpha), in patients with ankylosing spondylitis (AS). METHODS: Patients with active AS despite conventional treatment were randomised to placebo, or one of five subcutaneous dose regimens of sarilumab (100, 150 or 200 mg every other week, or 100 or 150 mg every week), for 12 weeks. The primary efficacy end point was the percentage of patients achieving the Axial SpondyloArthritis international Society (ASAS) 20 response criteria at week 12. Secondary endpoints included ASAS40 response, ASAS partial remission, AS Disease …