Journal ArticleDOI
Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomized, double-blind, placebo-controlled, phase III trial.
Robert D. Inman,John C. Davis,Désirée van der Heijde,Laura Diekman,Joachim Sieper,Sung-Il Kim,Michael Mack,J. Han,Sudha Visvanathan,Zhenhua Xu,Benjamin Hsu,A. Beutler,Jürgen Braun +12 more
Reads0
Chats0
TLDR
Golimumab was effective and well tolerated in a large cohort of patients with ankylosing spondylitis during a 24-week study period.Abstract:
Objective To evaluate the efficacy and safety of golimumab in patients with ankylosing spondylitis (AS) in the GO-RAISE study. Methods Patients with active AS, a Bath AS Disease Activity Index (BASDAI) score > or =4, and a back pain score of > or =4 were randomly assigned in a 1.8:1.8:1 ratio to receive subcutaneous injections of golimumab (50 mg or 100 mg) or placebo every 4 weeks. The primary end point was the proportion of patients with at least 20% improvement in the ASsessment in AS (ASAS20) criteria at week 14. Results At randomization, 138, 140, and 78 patients were assigned to the 50-mg, 100-mg, and placebo groups, respectively. After 14 weeks, 59.4%, 60.0%, and 21.8% of patients, respectively, were ASAS20 responders (P or =1 adverse event, and 5.4% and 6.5% of patients, respectively, had > or =1 serious adverse event. Eight golimumab-treated patients and 1 placebo-treated patient had markedly abnormal liver enzyme values (> or =100% increase from baseline and a value >150 IU/liter), which were transient. Conclusion Golimumab was effective and well tolerated in a large cohort of patients with AS during a 24-week study period.read more
Citations
More filters
Journal ArticleDOI
2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis
Désirée van der Heijde,Sofia Ramiro,Robert Landewé,Xenofon Baraliakos,Filip Van den Bosch,Alexandre Sepriano,Alexandre Sepriano,Andrea Regel,Adrian Ciurea,Hanne Dagfinrud,Maxime Dougados,Maxime Dougados,Floris A. van Gaalen,Pál Géher,Irene E. van der Horst-Bruinsma,Robert D. Inman,Merryn Jongkees,Uta Kiltz,Tore K Kvien,Pedro Machado,Helena Marzo-Ortega,Anna Molto,Anna Molto,Victoria Navarro-Compán,Salih Ozgocmen,Fernando Pimentel-Santos,John D. Reveille,Martin Rudwaleit,Martin Rudwaleit,J. Sieper,Percival D. Sampaio-Barros,Dieter Wiek,Jürgen Braun +32 more
TL;DR: The 2016 Assessment of SpondyloArthritis international Society-EULAR recommendations provide up-to-date guidance on the management of patients with axSpA and three overarching principles and 13 recommendations deal with surgery and spinal fractures.
Journal ArticleDOI
2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis
Jürgen Braun,R. van den Berg,Xenofon Baraliakos,H. Boehm,Ruben Burgos-Vargas,Eduardo Collantes-Estevez,B. Dijkmans,Paul Emery,Muhammad Asim Khan,Karel Pavelka +9 more
TL;DR: The ASAS/EULAR recommendations on the management of ankylo sing spondylitis (AS) are based on the original paper, a systematic review of existing recommendations and the literature since 2005 and the discussion and agreement among 21 international experts, 2 patients and 2 physiotherapists in a meeting in February 2010 as mentioned in this paper.
2010 Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis
Jürgen Braun,R. van den Berg,Xenofon Baraliakos,H. Boehm,Ruben Burgos-Vargas,Eduardo Collantes-Estevez,Hanne Dagfinrud,B. Dijkmans,Maxime Dougados,Paul Emery,P. Geher,Mohammed Hammoudeh,Robert D. Inman,Merryn Jongkees,Muhammad Asim Khan,Uta Kiltz,Tore K Kvien,Marjatta Leirisalo-Repo,Walter P. Maksymowych,I. Olivieri,Karel Pavelka,Joachim Sieper,Ewa Stanislawska-Biernat,D. Wendling,Salih Ozgocmen,C. Van Drogen,B.J. van Royen,D. van der Heijde +27 more
TL;DR: This first update of the ASAS/EULAR recommendations on the management of ankylosing spondylitis is based on the original paper, a systematic review of existing recommendations and the literature since 2005 and the discussion and agreement among 21 international experts, 2 patients and 2 physiotherapists in a meeting in February 2010.
Journal ArticleDOI
Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis
Dominique Baeten,Joachim Sieper,Jürgen Braun,Xenofon Baraliakos,Maxime Dougados,Paul Emery,Atul Deodhar,Brian Porter,Ruvie Martin,Mats Andersson,Shephard Mpofu,Hanno B. Richards +11 more
TL;DR: Secukinumab at a subcutaneous dose of 150 mg, with either sub cutaneous or intravenous loading, provided significant reductions in the signs and symptoms of ankylosing spondylitis at week 16, and was sustained through 52 weeks.
Journal ArticleDOI
Adverse effects of biologics: a network meta‐analysis and Cochrane overview
Jasvinder A. Singh,George A. Wells,Robin Christensen,Elizabeth Tanjong Ghogomu,Lara J Maxwell,John K MacDonald,Graziella Filippini,Nicole Skoetz,Damian K Francis,Luciane Cruz Lopes,Gordon Guyatt,Jochen Schmitt,Loredana La Mantia,Tobias Weberschock,Juliana F. Roos,Hendrik Siebert,Sarah. Hershan,Chris Cameron,Michael P. Lunn,Peter Tugwell,Peter Tugwell,Rachelle Buchbinder +21 more
TL;DR: The rate of serious adverse events, serious infections, lymphoma, and congestive heart failure were not statistically significantly different between biologics and control treatment, and direct comparisons revealed that abatacept and anakinra were associated with a significantly lower risk ofserious adverse events compared to most other biologicics.
References
More filters
Journal ArticleDOI
The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection.
John E. Ware,Cathy D. Sherbourne +1 more
TL;DR: A 36-item short-form survey designed for use in clinical practice and research, health policy evaluations, and general population surveys to survey health status in the Medical Outcomes Study is constructed.
Journal ArticleDOI
Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria.
TL;DR: The study showed the clinical history screening test for AS to be moderately sensitive, but it might be better in clinical practice, and substitution of the Rome pain criterion for the New York pain criterion is proposed.
Journal Article
A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index.
TL;DR: The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), a self-administered instrument, is superior to the DAI in terms of construct and content validity and to the Enthesis Index in all aspects.
Journal Article
A new approach to defining functional ability in ankylosing spondylitis: the development of the Bath Ankylosing Spondylitis Functional Index.
TL;DR: The Bath Ankylosing Spondylitis Functional Index satisfies the criteria required of a functional index: it is quick and easy to complete, is reliable and is sensitive to change across the whole spectrum of disease.
Journal ArticleDOI
The MOS 36-Item Short Form Health Survey: reliability, validity, and preliminary findings in schizophrenic outpatients.
Joan Russo,Carol A. Trujillo,Dane Wingerson,Kathleen P. Decker,Richard K. Ries,Harry Wetzler,Peter Roy-Byrne +6 more
TL;DR: The validity of using the written form of the SF-36 on a sample of patients with chronic mental illness was demonstrated and appears to be an appropriate outcome measure for changes in physical and role functioning in consumers of outpatient mental health programs.
Related Papers (5)
Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria.
The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection
Martin Rudwaleit,D. van der Heijde,Robert Landewé,Joachim Listing,Nurullah Akkoc,J Brandt,Jürgen Braun,C.T. Chou,Eduardo Collantes-Estevez,Maxime Dougados,Feng Huang,Jieruo Gu,Muhammad Asim Khan,Yesim Kirazli,Walter P. Maksymowych,Herman Mielants,Inge Juul Sørensen,Salih Ozgocmen,Euthalia Roussou,R. Valle-Oñate,Ulrich Weber,James Cheng-Chung Wei,Joachim Sieper +22 more