Publication: The ASAS-OMERACT core domain set for axial spondyloarthritis
Issued Date
2021-12-01
Resource Type
ISSN
1532866X
00490172
00490172
Other identifier(s)
2-s2.0-85114313781
Rights
Mahidol University
Rights Holder(s)
SCOPUS
Bibliographic Citation
Seminars in Arthritis and Rheumatism. Vol.51, No.6 (2021), 1342-1349
Suggested Citation
V. Navarro-Compán, A. Boel, A. Boonen, P. Mease, R. Landewé, U. Kiltz, M. Dougados, X. Baraliakos, W. Bautista-Molano, H. Carlier, P. Chiowchanwisawakit, H. Dagfinrud, N. de Peyrecave, B. El-Zorkany, L. Fallon, K. Gaffney, M. Garrido-Cumbrera, L. S. Gensler, N. Haroon, Y. H. Kwan, P. M. Machado, W. P. Maksymowych, D. Poddubnyy, M. Protopopov, S. Ramiro, B. Shea, I. H. Song, S. van Weely, D. van der Heijde The ASAS-OMERACT core domain set for axial spondyloarthritis. Seminars in Arthritis and Rheumatism. Vol.51, No.6 (2021), 1342-1349. doi:10.1016/j.semarthrit.2021.07.021 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/77538
Research Projects
Organizational Units
Authors
Journal Issue
Thesis
Title
The ASAS-OMERACT core domain set for axial spondyloarthritis
Author(s)
V. Navarro-Compán
A. Boel
A. Boonen
P. Mease
R. Landewé
U. Kiltz
M. Dougados
X. Baraliakos
W. Bautista-Molano
H. Carlier
P. Chiowchanwisawakit
H. Dagfinrud
N. de Peyrecave
B. El-Zorkany
L. Fallon
K. Gaffney
M. Garrido-Cumbrera
L. S. Gensler
N. Haroon
Y. H. Kwan
P. M. Machado
W. P. Maksymowych
D. Poddubnyy
M. Protopopov
S. Ramiro
B. Shea
I. H. Song
S. van Weely
D. van der Heijde
A. Boel
A. Boonen
P. Mease
R. Landewé
U. Kiltz
M. Dougados
X. Baraliakos
W. Bautista-Molano
H. Carlier
P. Chiowchanwisawakit
H. Dagfinrud
N. de Peyrecave
B. El-Zorkany
L. Fallon
K. Gaffney
M. Garrido-Cumbrera
L. S. Gensler
N. Haroon
Y. H. Kwan
P. M. Machado
W. P. Maksymowych
D. Poddubnyy
M. Protopopov
S. Ramiro
B. Shea
I. H. Song
S. van Weely
D. van der Heijde
Other Contributor(s)
Siriraj Hospital
Instituto de Investigación Sanitaria del Hospital Universitario La Paz
Duke-NUS Medical School
Eli Lilly Benelux
Fundacion Santa Fe de Bogota
Diakonhjemmet Sykehus
Universidad de Sevilla
Rheumazentrum Ruhrgebiet
Charité – Universitätsmedizin Berlin
University of California, San Francisco
University College London
AP-HP Assistance Publique - Hopitaux de Paris
University of Alberta, Faculty of Medicine and Dentistry
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of Toronto
Leids Universitair Medisch Centrum
Swedish Medical Center, Seattle
Cairo University
Maastricht Universitair Medisch Centrum+
Pfizer Inc.
Ottawa Hospital Research Institute
Amsterdam UMC - University of Amsterdam
UBC Pharma
Immunology Clinical Development
Instituto de Investigación Sanitaria del Hospital Universitario La Paz
Duke-NUS Medical School
Eli Lilly Benelux
Fundacion Santa Fe de Bogota
Diakonhjemmet Sykehus
Universidad de Sevilla
Rheumazentrum Ruhrgebiet
Charité – Universitätsmedizin Berlin
University of California, San Francisco
University College London
AP-HP Assistance Publique - Hopitaux de Paris
University of Alberta, Faculty of Medicine and Dentistry
Norfolk and Norwich University Hospitals NHS Foundation Trust
University of Toronto
Leids Universitair Medisch Centrum
Swedish Medical Center, Seattle
Cairo University
Maastricht Universitair Medisch Centrum+
Pfizer Inc.
Ottawa Hospital Research Institute
Amsterdam UMC - University of Amsterdam
UBC Pharma
Immunology Clinical Development
Abstract
Background: The current core outcome set for ankylosing spondylitis (AS) has had only minor adaptations since its development 20 years ago. Considering the significant advances in this field during the preceding decades, an update of this core set is necessary. Objective: To update the ASAS-OMERACT core outcome set for AS into the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA). Methods: Following OMERACT and COMET guidelines, an international working group representing key stakeholders (patients, rheumatologists, health professionals, pharmaceutical industry and drug regulatory agency representatives) defined the core domain set for axSpA. The development process consisted of: i) Identifying candidate domains using a systematic literature review and qualitative studies; ii) Selection of the most relevant domains for different stakeholders through a 3-round Delphi survey involving axSpA patients and axSpA experts; iii) Consensus and voting by ASAS; iv) Endorsement by OMERACT. Two scenarios are considered based on the type of therapy investigated in the trial: symptom modifying therapies and disease modifying therapies. Results: The updated core outcome set for axSpA includes 7 mandatory domains for all trials (disease activity, pain, morning stiffness, fatigue, physical function, overall functioning and health, and adverse events including death). There are 3 additional domains (extra-musculoskeletal manifestations, peripheral manifestations and structural damage) that are mandatory for disease modifying therapies and important but optional for symptom modifying therapies. Finally, 3 other domains (spinal mobility, sleep, and work and employment) are defined as important but optional domains for all trials. Conclusion: The ASAS-OMERACT core domain set for AS has been updated into the ASAS-OMERACT core domain set for axSpA. The next step is the selection of instruments for each domain.