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OP0148 (2022)
THE ASAS CORE MEASUREMENT SET FOR AXIAL SPONDYLOARTHRITIS
V. Navarro-Compán1, A. Boel2, A. Boonen3, P. J. Mease4, M. Dougados5, U. Kiltz6, R. B. M. Landewé7, D. van der Heijde2, on behalf of The ASAS axSpA core measurement set working group
1Hospital La Paz, IdiPaz, Rheumatology, Madird, Spain
2LUMC, Rheumatology, Leiden, Netherlands
3MUMC+, Rheumatology, Maastricht, Netherlands
4Swedish Medical Center/Providence St, Joseph Health and the University of Washington, Rheumatology, Seatle, United States of America
5Cochin Hospital, Rheumatology, Paris, France
6Rheumazentrum Ruhrgebiet, Ruhr-Universität, Rheumatology, Bochum, Herne, Germany
7Rheumatologist, Zuyderland MC, Rheumatology, Heerlen, Netherlands

Background: Recently, the core domains of the 20-years old core outcome set for ankylosing spondylitis were updated. 1 The next step is to define the measurement core set, which includes at least one instrument for each domain.


Objectives: To define the instruments for the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).


Methods: The scientific committee invited an international working group representing all key stakeholders (patients, rheumatologists, health professionals and pharmaceutical industry). The instrument selection process is presented in Figure 1 .

Development process to determine the core measurement set


Results: The updated core measurement set for axSpA is shown in Table 1 . This includes seven instruments for six domains that are mandatory for all trials: ASDAS and NRS patient global assessment for disease activity, NRS total back pain for pain, composite index for morning stiffness, NRS fatigue for fatigue, BASFI for physical function, and ASAS Health Index for overall functioning and health. There are 9 additional instruments for disease modifying drugs (DMARDs): two MRI activity scores (SPARCC SIJ and SPARCC spine) for disease activity, the three extra-musculoskeletal manifestations uveitis, IBD and psoriasis assessed as recommended by ASAS 2 , the three peripheral manifestations (44 swollen joint count, MASES and Dactylitis count 2 ) and mSASSS for structural damage. The imaging outcomes are mandatory to be included at least in one trial for a drug that is considered to be a DMARD. The other instruments specific for DMARDs should be included in every trial. This core set is applicable to patients with radiographic and non-radiographic axSpA. Furthermore, 11 other instruments were also endorsed by ASAS and can additionally be used in axSpA trials: BASDAI, CRP, Berlin MRI-SIJ and MRI-spine activity scores for disease activity, NRS back pain at night for pain, severity (BASDAI Q5) and duration (BASDAI Q6) for morning stiffness, SF-36 for overall functioning and health, 66 swollen joint count and SPARCC enthesitis for peripheral manifestations and MRI-SIJ erosions scores (SPARCC SSS) for structural damage.

Updated core measurement set for axial spondyloarthritis.

Instruments mandatory for all trials
Domain Instrument
 Disease activity ASDAS
Patient global assessment of disease activity (NRS)
 Pain NRS total back pain (BASDAI Q2)
 Morning stiffness Severity and duration (BASDAI (Q5+Q6)/2))
 Fatigue NRS fatigue (BASDAI Q1)
 Physical function BASFI
 Overall functioning & health ASAS Health Index
Additional instruments mandatory for disease modifying drugs trials
 Disease activity SPARCC MRI-SIJ*
SPARCC MRI-spine*
 Extra-musculoskeletal manifestations uveitis (ASAS CRF) 2
psoriasis (ASAS CRF) 2
inflammatory bowel disease (ASAS CRF) 2
 Peripheral manifestations 44 Swollen joint count
MASES
Dactylitis count (ASAS CRF) 2
 Structural damage mSASSS*

*Needs to be assessed at least once in a disease modifying drug programme; 2 Dougados M, et al. Ann Rheum Dis 2012;71(6):1103-04. ASDAS: Ankylosing Spondylitis Disease Activity Score; NRS: Numerical Rate Scale; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; Q: question; BASFI: Bath Ankylosing Spondylitis Functional Index; SPARCC: SpondyloArthritis Research Consortium of Canada Scoring System; MRI: Magnetic Resonance Imaging; SIJ: Sacroiliac Joint; CRF: Case Report Form; MASES: Maastricht Ankylosing Spondylitis Enthesitis Score; mSASSS: modified Stoke Ankylosing Spondylitis Spinal Score.


Conclusion: The previous core measurement set has been updated and endorsed by ASAS for the use in all axSpA trials.


REFERENCES:

[1]Navarro-Compán V, et al. Semin Arthritis Rheum 2021;51(6):1342-49.

[2]Dougados M, et al. Annals of the Rheumatic Diseases 2012;71(6):1103-04.


Acknowledgements: The ASAS axSpA core measurement set working group:

Désirée van der Heijde

Victoria Navarro Compán

Annelies Boonen

Philip Mease

Anne Boel

Uta Kiltz

Robert Landewé

Maxime Dougados

Xenofon Baraliakos

Wilson Bautista

Pravina Chiowchanwisawakit

Yu Heng Kwan

Lianne Gensler

Bassel El-Zorkany

Karl Gaffney

Nigel Haroon

Pedro Machado

Walter Maksymowych

Anna Molto

Denis Poddubnyy

Mikhail Protopopov

Sofia Ramiro

Salima van Weely

Marco Garrido Cumbrera

Natasha de Peyrecave

Lara Fallon

In-Ho Song

Hanne Dagfinrud

The Assessment of Spondyloarthritis international Society (ASAS) supported Anne Boel and Victoria Navarro-Compán financially to update the core outcome set.


Disclosure of Interests: Victoria Navarro-Compán Speakers bureau: AbbVie, Eli Lilly, Janssen, MSD, Novartis, Pfizer, UCB Pharma, Consultant of: AbbVie, Eli Lilly, MSD, Novartis, Pfizer, UCB Pharma; Research grants from AbbVie and Novartis, Grant/research support from: AbbVie and Novartis, Anne Boel: None declared, Annelies Boonen Speakers bureau: Abbvie / Galapagos, Consultant of: Galapagos, Grant/research support from: AbbVie, Philip J Mease Speakers bureau: Abbvie, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma, UCB, Grant/research support from: Abbvie, Bristol Myers, Gilead, Inmagene, Janssen, Lilly, Novartis, Pfizer, UCB, Maxime Dougados: None declared, Uta Kiltz Consultant of: AbbVie, Chugai, Eli Lilly, Fresenius, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche and UCB, Grant/research support from: Abbvie, Amgen, Biogen, Hexal, Novartis und Pfizer, Robert B.M. Landewé Consultant of: AbbVie, BMS, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, UCB, Désirée van der Heijde Consultant of: AbbVie, Bayer, BMS, Cyxone, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Novartis, Pfizer, UCB Pharma, Employee of: Director of Imaging Rheumatology bv.

Citation: , volume 81, supplement 1, year 2022, page 95
Session: Spondyloarthritis in practice: imaging, outcome assessment and comorbidities (Oral Presentations)