OP0148 THE ASAS CORE MEASUREMENT SET FOR AXIAL SPONDYLOARTHRITIS

Abstract

BackgroundRecently, 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.ObjectivesTo define the instruments for the ASAS-OMERACT core outcome set for axial spondyloarthritis (axSpA).MethodsThe 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.Figure 1.Development process to determine the core measurement setResultsThe 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 ASAS2, the three peripheral manifestations (44 swollen joint count, MASES and Dactylitis count2) 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.Table 1.Updated core measurement set for axial spondyloarthritis.Instruments mandatory for all trialsDomainInstrument Disease activityASDASPatient global assessment of disease activity (NRS) PainNRS total back pain (BASDAI Q2) Morning stiffnessSeverity and duration (BASDAI (Q5+Q6)/2)) FatigueNRS fatigue (BASDAI Q1) Physical functionBASFI Overall functioning & healthASAS Health IndexAdditional instruments mandatory for disease modifying drugs trials Disease activitySPARCC MRI-SIJ*SPARCC MRI-spine* Extra-musculoskeletal manifestationsuveitis (ASAS CRF)2psoriasis (ASAS CRF)2inflammatory bowel disease (ASAS CRF)2 Peripheral manifestations44 Swollen joint countMASESDactylitis count (ASAS CRF)2 Structural damagemSASSS**Needs to be assessed at least once in a disease modifying drug programme; 2Dougados 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.ConclusionThe 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.AcknowledgementsThe ASAS axSpA core measurement set working group:Désirée van der HeijdeVictoria Navarro CompánAnnelies BoonenPhilip MeaseAnne BoelUta KiltzRobert LandewéMaxime DougadosXenofon BaraliakosWilson BautistaPravina ChiowchanwisawakitYu Heng KwanLianne GenslerBassel El-ZorkanyKarl GaffneyNigel HaroonPedro MachadoWalter MaksymowychAnna MoltoDenis PoddubnyyMikhail ProtopopovSofia RamiroSalima van WeelyMarco Garrido CumbreraNatasha de PeyrecaveLara FallonIn-Ho SongHanne DagfinrudThe Assessment of Spondyloarthritis international Society (ASAS) supported Anne Boel and Victoria Navarro-Compán financially to update the core outcome set.Disclosure of InterestsVictoria 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.