Objectives To define the instruments for the Assessment of SpondyloArthritis international Society–Outcomes Measures in Rheumatology (ASAS-OMERACT) core domain set for axial spondyloarthritis (axSpA).
Methods An international working group representing key stakeholders selected the core outcome instruments following a predefined process: (1) identifying candidate instruments using a systematic literature review; (2) reducing the list of candidate instruments by the working group, (3) assessing the instruments’ psychometric properties following OMERACT filter 2.2, (4) selection of the core instruments by the working group and (5) voting and endorsement by ASAS.
Results The updated core set for axSpA includes seven instruments for the domains that are mandatory for all trials: Ankylosing Spondylitis Disease Activity Score and Numerical Rate Scale (NRS) patient global assessment of disease activity, NRS total back pain, average NRS of duration and severity of morning stiffness, NRS fatigue, Bath Ankylosing Spondylitis Function Index and ASAS Health Index. There are 9 additional instruments considered mandatory for disease-modifying antirheumatic drugs (DMARDs) trials: MRI activity Spondyloarthritis Research Consortium of Canada (SPARCC) sacroiliac joints and SPARCC spine, uveitis, inflammatory bowel disease and psoriasis assessed as recommended by ASAS, 44 swollen joint count, Maastricht Ankylosing Spondylitis Enthesitis Score, dactylitis count and modified Stoke Ankylosing Spondylitis Spinal Score. The imaging outcomes are considered mandatory to be included in at least one trial for a drug tested for properties of DMARD. Furthermore, 11 additional instruments were also endorsed by ASAS, which can be used in axSpA trials on top of the core instruments.
Conclusions The selection of the instruments for the ASAS-OMERACT core domain set completes the update of the core outcome set for axSpA, which should be used in all trials.
- spondylitis, ankylosing
- outcome assessment, health care
- outcome and process assessment, health care
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VN-C and AB are joint first authors.
Handling editor Josef S Smolen
Twitter @wabautistam, @pedrommcmachado, @annamolto, @MProtopopov
Contributors VN-C, ABoel and DvdH wrote the first draft of the manuscript. All authors participated actively in the project. All authors critically reviewed the manuscript for important intellectual contribution and approved the final version.
Funding The Assessment of SpondyloArthritis international Society funded ABoel and VN-C to work on the project to update the core outcome set.
Competing interests VN-C: grants/honoraria from AbbVie, Janssen, Lilly, Novartis, Pfizer and UCB. ABoonen: grants from AbbVie ad Novartis and honoraria for boards or lectures form Abbvie, Galapagos and Lilly. PJM: research grants, consultation fees and/or speaker honoraria from Abbvie, Aclaris, Amgen, Bristol Myers, Boehringer-Ingelheim, Galapagos, Gilead, GlaxoSmithKline, Inmagene, Janssen, Lilly, Novartis, Pfizer, SUN Pharma and UCB. MD: consulting fees Pfizer, AbbVie, Amgen, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pharma. UK: grant and research support and consultancy fees from AbbVie, Amgen, Biogen, Chugai, Eli Lilly, Fresenius, Gilead, GSK, Janssen, MSD, Novartis, Pfizer, Roche and UCB. RBML: honoraria from AbbVie, AstraZeneca, BMS, Boehringer Ingelheim, Celgene, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli-Lilly, Novartis, Pfizer and UCB Pharma; Director of Rheumatology Consultancy BV. XB: consulting fees AbbVie, Amgen, BMS, Celgene, Galapagos, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB. WB-M: research speaker's fees from Janssen, Lilly, Novartis, Pfizer and Biopas. PC: research grants/honoraria from Novartis, Pfizer, Zuellig Pharma and Janssen. LF: employee and shareholder of Pfizer. MG-C: research collaboration with and provides services to Novartis Pharma AG. LG: research grants/honoraria from AbbVie, Eli Lilly, Gilead, GSK, Janssen, Novartis, Pfizer and UCB. BKE: consultancy, research grants and speaker's fees from AbbVie, Amgen, BMS, Eva, Hekma, Janssen, Lilly, MSD, New Bridge, Novartis, Pfizer, Roche, Sanofi‐Aventis and Servier. NH: consultant for Amgen, Abbvie, Eli Lilly, Janssen, Merck, Novartis, Pfizer and UCB. PMM: consulting/speaker’s fees from Abbvie, BMS, Celgene, Eli Lilly, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript. WM: consulting fees Abbvie, BMS, Boehringer, Celgene, Lilly, Janssen, Novartis, Pfizer and UCB; research and/or educational grants from Abbvie, Novartis and Pfizer; Chief Medical Officer CARE Arthritis Limited. AM: speaker honoraria for lectures, presentations from Abbvie, UCB, Novartis, Pfizer, Gilead, Janssen, MSD, BMS, Biogen and Lilly. NdP: employee of UCB Pharma. DP: research support from AbbVie, Lilly, MSD, Novartis and Pfizer, consulting fees from AbbVie, Biocad, Gilead, GlaxoSmithKline, Eli Lilly, MSD, Novartis, Pfizer, Samsung Bioepis and UCB and speaker fees from AbbVie, Bristol-Myers Squibb, Lilly, MSD, Novartis, Pfizer and UCB. MP: speaker honoraria for lectures, presentations from Novartis and UCB. SR: research grants from Galapagos, MSD, Novartis and Pfizer and consulting fees from AbbVie, Eli Lilly, MSD, Novartis, UCB and Sanofi. I-HS: employee of AbbVie, Immunology Clinical Development, USA. DvdH: consulting fees AbbVie, Amgen, Astellas, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Celgene, Cyxone, Daiichi, Eisai, Galapagos, Gilead, Glaxo-Smith-Kline, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, UCB Pharma; Director of Imaging Rheumatology bv. ABoel, HD, YHK and SvW: no competing interests to declare.
Provenance and peer review Not commissioned; externally peer reviewed.
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