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- DMARDs (biologic) (3)
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Articles 1 - 9 of 9
Full-Text Articles in Rheumatology
Tocilizumab Combination Therapy Or Monotherapy Or Methotrexate Monotherapy In Methotrexate-Naive Patients With Early Rheumatoid Arthritis: 2-Year Clinical And Radiographic Results From The Randomised, Placebo-Controlled Function Trial, Gerd R. Burmester, William F. Rigby, Ronald F. Van Vollenhoven, Jonathan Kay, Andrea Rubbert-Roth, Ricardo Blanco, Alysha Kadva, Sophie Dimonaco
Tocilizumab Combination Therapy Or Monotherapy Or Methotrexate Monotherapy In Methotrexate-Naive Patients With Early Rheumatoid Arthritis: 2-Year Clinical And Radiographic Results From The Randomised, Placebo-Controlled Function Trial, Gerd R. Burmester, William F. Rigby, Ronald F. Van Vollenhoven, Jonathan Kay, Andrea Rubbert-Roth, Ricardo Blanco, Alysha Kadva, Sophie Dimonaco
Jonathan Kay
OBJECTIVE: Investigate whether the efficacy and safety of intravenous tocilizumab (TCZ) demonstrated at week 52 in patients with early rheumatoid arthritis (RA) are maintained to week 104. METHODS: Methotrexate (MTX)-naive patients with early progressive RA were randomly assigned to double-blind 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo or placebo+MTX for 104 weeks. Patients not receiving 8 mg/kg TCZ and not achieving Disease Activity Score-28 joints (DAS28-erythrocyte sedimentation rate (ESR)) < /=3.2 at week 52 switched to escape therapy (8 mg/kg TCZ+MTX). Analyses were exploratory. RESULTS: Intent-to-treat and safety populations included 1157 and 1153 patients, respectively. DAS28-ESR remission ( < 2.6) …
The Changing Landscape Of Biosimilars In Rheumatology, Thomas Dorner, Vibeke Strand, Paul Cornes, Joao Goncalves, Laszlo Gulacsi, Jonathan Kay, Tore K. Kvien, Josef S. Smolen, Yoshiya Tanaka, Gerd R. Burmester
The Changing Landscape Of Biosimilars In Rheumatology, Thomas Dorner, Vibeke Strand, Paul Cornes, Joao Goncalves, Laszlo Gulacsi, Jonathan Kay, Tore K. Kvien, Josef S. Smolen, Yoshiya Tanaka, Gerd R. Burmester
Jonathan Kay
Biosimilars remain a hot topic in rheumatology, and some physicians are cautious about their application in the real world. With many products coming to market and a wealth of guidelines and recommendations concerning their use, there is a need to understand the changing landscape and the real clinical and health-economic potential offered by these agents. Notably, rheumatologists will be at the forefront of the use of biosimilar monoclonal antibodies/soluble receptors. Biosimilars offer cost savings and health gains for our patients and will play an important role in treating rheumatic diseases. We hope that these lower costs will compensate for inequities …
Biosimilars In Rheumatology: What The Clinician Should Know, Gilberto Castaneda-Hernandez, Rodrigo Gonzalez-Ramirez, Jonathan Kay, Morton A. Scheinberg
Biosimilars In Rheumatology: What The Clinician Should Know, Gilberto Castaneda-Hernandez, Rodrigo Gonzalez-Ramirez, Jonathan Kay, Morton A. Scheinberg
Jonathan Kay
Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.
Tocilizumab In Early Progressive Rheumatoid Arthritis: Function, A Randomised Controlled Trial, Gerd R. Burmester, William F. Rigby, Ronald F. Van Vollenhoven, Jonathan Kay, Andrea Rubbert-Roth, Ariella Kelman, Sophie Dimonaco, Nina Mitchell
Tocilizumab In Early Progressive Rheumatoid Arthritis: Function, A Randomised Controlled Trial, Gerd R. Burmester, William F. Rigby, Ronald F. Van Vollenhoven, Jonathan Kay, Andrea Rubbert-Roth, Ariella Kelman, Sophie Dimonaco, Nina Mitchell
Jonathan Kay
OBJECTIVES: The efficacy of tocilizumab (TCZ), an anti-interleukin-6 receptor antibody, has not previously been evaluated in a population consisting exclusively of patients with early rheumatoid arthritis (RA). METHODS: In a double-blind randomised controlled trial (FUNCTION), 1162 methotrexate (MTX)-naive patients with early progressive RA were randomly assigned (1:1:1:1) to one of four treatment groups: 4 mg/kg TCZ+MTX, 8 mg/kg TCZ+MTX, 8 mg/kg TCZ+placebo and placebo+MTX (comparator group). The primary outcome was remission according to Disease Activity Score using 28 joints (DAS28-erythrocyte sedimentation rate (ESR) < 2.6) at week 24. Radiographic and physical function outcomes were also evaluated. We report results through week …
Golimumab In Patients With Active Rheumatoid Arthritis After Treatment With Tumor Necrosis Factor Inverted Question Mark Inhibitors: Findings With Up To Five Years Of Treatment In The Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Go-After Study, Josef S. Smolen, Jonathan Kay, Mittie Doyle, Robert Landewe, Eric L. Matteson, Norman Gaylis, Jurgen Wollenhaupt, Frederick T. Murphy, Stephen Xu, Yiying Zhou, Elizabeth C. Hsia
Golimumab In Patients With Active Rheumatoid Arthritis After Treatment With Tumor Necrosis Factor Inverted Question Mark Inhibitors: Findings With Up To Five Years Of Treatment In The Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Go-After Study, Josef S. Smolen, Jonathan Kay, Mittie Doyle, Robert Landewe, Eric L. Matteson, Norman Gaylis, Jurgen Wollenhaupt, Frederick T. Murphy, Stephen Xu, Yiying Zhou, Elizabeth C. Hsia
Jonathan Kay
Introduction: The aim of this study was to assess long-term golimumab therapy in rheumatoid arthritis (RA) patients who discontinued previous tumor necrosis factor- inverted question mark (TNF)-inhibitor(s). Methods:Patients enrolled into this multicenter, randomized, double-blind, placebo-controlled study of active RA ( inverted question mark4 tender, inverted question mark4 swollen joints) received placebo (Group 1) or golimumab 50 mg (Group 2) or 100 mg (Group 3) injections every 4 weeks. Patients in Groups 1 and 2 with inadequate response at week 16 escaped to golimumab 50 and 100 mg, respectively. At week 24, Group 1 patients crossed-over to golimumab 50 mg, Group …
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 …
Detection Of Igg4-Specific Autoantibodies In Rheumatoid Arthritis Serum Samples, Azra Borogovac, Youmna Lahoud, Janice Weaver, Sheldon M. Cooper, Mercedes Rincon, Jonathan Kay, Ellen M. Gravallese
Detection Of Igg4-Specific Autoantibodies In Rheumatoid Arthritis Serum Samples, Azra Borogovac, Youmna Lahoud, Janice Weaver, Sheldon M. Cooper, Mercedes Rincon, Jonathan Kay, Ellen M. Gravallese
Jonathan Kay
Background: Rheumatoid arthritis (RA) is a chronic multi-system autoimmune disease characterized by inflammatory synovitis. Autoantibodies such as rheumatoid factor (RF) and anti-citrullinated protein antibodies (ACPA) have been implicated in the pathogenesis of RA, and are currently important criteria for diagnosis within the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria.1 Yet, many patients diagnosed with RA do not have measurable circulating ACPA or RF which may result in delayed diagnosis and treatment. After IgG1, IgG4 is the second most predominant isotype among ACPA and RF; however it is not detected in currently available diagnostic assays. Recent …
Clinical Disease Activity And Acute Phase Reactant Levels Are Discordant Among Patients With Active Rheumatoid Arthritis: Acute Phase Reactant Levels Contribute Separately To Predicting Outcome At One Year, Jonathan Kay, Olga Morgacheva, Susan P. Messing, Joel M. Kremer, Jeffrey D. Greenberg, George W. Reed, Ellen M. Gravallese, Daniel E. Furst
Clinical Disease Activity And Acute Phase Reactant Levels Are Discordant Among Patients With Active Rheumatoid Arthritis: Acute Phase Reactant Levels Contribute Separately To Predicting Outcome At One Year, Jonathan Kay, Olga Morgacheva, Susan P. Messing, Joel M. Kremer, Jeffrey D. Greenberg, George W. Reed, Ellen M. Gravallese, Daniel E. Furst
Jonathan Kay
INTRODUCTION: Clinical trials of new treatments for rheumatoid arthritis (RA) typically require subjects to have an elevated acute phase reactant (APR), in addition to tender and swollen joints. However, despite the elevation of individual components of the Clinical Disease Activity Index (CDAI) (tender and swollen joint counts and patient and physician global assessment), some patients with active RA may have normal erythrocyte sedimentation rate (ESR) and/or C-reactive protein (CRP) levels and thus fail to meet entry criteria for clinical trials. We assessed the relationship between CDAI and APRs in the Consortium of Rheumatology Researchers of North America (CORRONA) registry by …