Journal ArticleDOI
Ankylosing Spondylitis Disease Activity Score (ASDAS) : defining cut-off values for disease activity states and improvement scores
Pedro Machado,Robert Landewé,Elisabeth Lie,Tore K Kvien,Jürgen Braun,Daniel Baker,Désirée van der Heijde +6 more
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TLDR
Cut-off values for disease activity states and improvement using the Ankylosing SpondyloArthritis Disease Activity Score have been developed and proved to have external validity and a good performance compared to existing criteria.Abstract:
Background The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in ankylosing spondylitis (AS). It fulfi ls important aspects of truth, feasibility and discrimination. Criteria for disease activity states and improvement scores are important for use in clinical practice, observational studies and clinical trials and so far have not been developed for the ASDAS. Objective To determine clinically relevant cut-off values for disease activity states and improvement scores using the ASDAS. Methods For the selection of cut-offs data from the Norwegian disease modifying antirheumatic drug (NORDMARD) registry, a cohort of patients with AS starting conventional or biological DMARDs, were used. Receiver operating characteristic analysis against several external criteria was performed and several approaches to determine the optimal cut-offs used. The fi nal choice was made on clinical and statistical grounds, after debate and voting by Assessment of SpondyloArthritis international Society members. Crossvalidation was performed in NOR-DMARD and in Ankylosing Spondylitis Study for the Evaluation of Recombinant Infl iximab Therapy, a database of patients with AS participating in a randomised placebo-controlled trial with a tumour necrosis factor blocker. Results Four disease activity states were chosen by consensus: inactive disease, moderate, high and very high disease activity. The three cut-offs selected to separate these states were: 1.3, 2.1 and 3.5 units. Selected cut-offs for improvement were: change ≥1.1 units for clinically important improvement and change ≥2.0 units for major improvement. Results of the crossvalidation strongly supported the cut-offs. Conclusions Cut-off values for disease activity states and improvement using the ASDAS have been developed. They proved to have external validity and a good performance compared to existing criteria.read more
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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
Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial
K. K. Jørgensen,Inge C. Olsen,G. L. Goll,M. Lorentzen,Nils Bolstad,Espen A Haavardsholm,Knut E.A. Lundin,Knut E.A. Lundin,C. Mørk,Jørgen Jahnsen,Jørgen Jahnsen,Tore K Kvien,Ingrid Prytz Berset,Bjørg Ts Fevang,Jon Florholmen,Synøve Kalstad,Nils J Mørk,Kristin Ryggen,Kåre S Tveit,Sigrun K Sæther,Bjørn Gulbrandsen,Jon Hagfors,Kenneth Waksvik,David J. Warren,Karoline J. Henanger,Øivind Asak,Somyeh Baigh,Ingrid M. Blomgren,Trude J Bruun,Katrine Dvergsnes,Svein Oskar Frigstad,Clara Gram Gjesdal,Berit H J Grandaunet,Inger M Hansen,Ingvild S H Hatten,Gert Huppertz-Hauss,Magne Henriksen,Sunniva S Hoie,Jan Krogh,Julia R Kruse,Maud-Kristine A Ljoså,Irina P Midtgard,Pawel Mielnik,Bjørn Moum,Geir Noraberg,Armin Poyan,Ulf Prestegård,Haroon U Rashid,Jan Henrik Rydning,Liv Sagatun,Kathrine A. Seeberg,Kristine Skjetne,E. K. Strand,Hilde Stray,Njaal Stray,Roald Torp,Cecilia Vold,Carl Magnus Ystrøm,Camilla C Zettel +58 more
TL;DR: The NOR-SWITCH trial showed that switching from originator infliximab originator to CT-P13 was not inferior to continued treatment with inflIXimaboriginator according to a prespecified non-inferiority margin of 15%.
Journal ArticleDOI
Treating axial spondyloarthritis and peripheral spondyloarthritis, especially psoriatic arthritis, to target: 2017 update of recommendations by an international task force
Josef S. Smolen,Monika Schöls,Jürgen Braun,Maxime Dougados,Oliver FitzGerald,Dafna D. Gladman,Arthur Kavanaugh,Robert Landewé,Philip J. Mease,Joachim Sieper,Tanja Stamm,Maarten de Wit,Daniel Aletaha,Xenofon Baraliakos,Neil Betteridge,Filip Van den Bosch,Laura C. Coates,Paul Emery,Lianne S. Gensler,Laure Gossec,Philip S. Helliwell,Merryn Jongkees,Tore K Kvien,Robert D. Inman,Iain B. McInnes,Mara Maccarone,Pedro Machado,Anna Molto,Alexis Ogdie,Denis Poddubnyy,Christopher T. Ritchlin,Martin Rudwaleit,Adrian Tanew,Bing Thio,Douglas J. Veale,Kurt de Vlam,Désirée van der Heijde +36 more
TL;DR: There was broad agreement, now better supported by data than in 2012, that remission/inactive disease and, alternatively, low/minimal disease activity are the principal targets for the treatment of PsA.
Journal ArticleDOI
Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis : results of a randomised placebo-controlled trial (ABILITY-1)
Joachim Sieper,Désirée van der Heijde,Maxime Dougados,Philip J. Mease,Walter P. Maksymowych,Matthew A. Brown,Vipin Arora,Aileen L. Pangan +7 more
TL;DR: Results from ABILITY-1 suggest that adalimumab has a positive benefit–risk profile in active nr-axSpA patients with inadequate response to NSAIDs and the safety profile was consistent with what is known for ad alimumab in ankylosing spondylitis and other diseases.
Journal ArticleDOI
Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: recommendations of an international task force
Josef S Smolen,Jürgen Braun,Maxime Dougados,Paul Emery,Oliver FitzGerald,Philip S. Helliwell,Arthur Kavanaugh,Tore K Kvien,Robert Landewé,Thomas A. Luger,Philip J. Mease,Ignazio Olivieri,John D. Reveille,Christopher T. Ritchlin,Martin Rudwaleit,Monika Schoels,Joachim Sieper,Martinus de Wit,Xenofon Baraliakos,Neil Betteridge,Ruben Burgos-Vargas,Eduardo Collantes-Estevez,Atul Deodhar,Dirk Elewaut,Laure Gossec,Merryn Jongkees,Mara Maccarone,Kurt Redlich,Filip Van den Bosch,James Cheng-Chung Wei,Kevin L. Winthrop,Désirée van der Heijde +31 more
TL;DR: The task force defined the treatment target for SpA as remission or, alternatively, low disease activity, being aware that the evidence base is not strong and needs to be expanded by future research.
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