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Instrument selection for the ASAS core outcome set for axial spondyloarthritis
  1. Victoria Navarro-Compán1,2,
  2. Anne Boel3,
  3. Annelies Boonen4,5,
  4. Philip J Mease6,
  5. Maxime Dougados7,
  6. Uta Kiltz8,
  7. Robert B M Landewé9,10,
  8. Xenofon Baraliakos11,
  9. Wilson Bautista-Molano12,
  10. Praveena Chiowchanwisawakit13,
  11. Hanne Dagfinrud14,
  12. Lara Fallon15,
  13. Marco Garrido-Cumbrera16,17,
  14. Lianne Gensler18,
  15. Bassel Kamal ElZorkany19,
  16. Nigil Haroon20,
  17. Yu Heng Kwan21,
  18. Pedro M Machado22,23,24,
  19. Walter Maksymowych25,
  20. Anna Molto7,
  21. Natasha de Peyrecave26,
  22. Denis Poddubnyy27,
  23. Mikhail Protopopov28,
  24. Sofia Ramiro3,29,
  25. In-Ho Song30,
  26. Salima van Weely31,
  27. Désirée van der Heijde3
  1. 1 Department of Rheumatology, La Paz University Hospital, Madrid, Spain
  2. 2 IdiPaz, Madrid, Spain
  3. 3 Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands
  4. 4 Department of Internal Medicine, Division of Rheumatology, Maastrich University Medical Center, Maastricht, The Netherlands
  5. 5 Care and Public Health Research Institute, Maastricht University, Maastricht, The Netherlands
  6. 6 Department of Rheumatology Research, Swedish Medical Center, Seattle, Washington, USA
  7. 7 Department of Rheumatology, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris INSERM (U1153): Clinical epidemiology and biostatistics, PRES Sorbonne Paris-Cité, Paris, France
  8. 8 Department of Rheumatology, Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Germany
  9. 9 Amsterdam Rheumatology Center, Amsterdam, The Netherlands
  10. 10 Department of Rheumatology, Zuyderland MC, Heerlen, The Netherlands
  11. 11 Rheumazentrum Ruhrgebiet, Ruhr-Universität Bochum, Herne, Germany
  12. 12 School of Medicine, University Hospital Fundación Santa Fe de Bogotá, Universidad El Bosque, Bogotá, Colombia
  13. 13 Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  14. 14 Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway
  15. 15 Inflammation and Immunology – Global Medical Affairs, Pfizer Inc, Montreal, Québec, Canada
  16. 16 Health and Territory Research, Universidad de Sevilla, Sevilla, Spain
  17. 17 Axial Spondyloarthritis International Federation, London, UK
  18. 18 Department of Medicine, Division of Rheumatology, University of California San Francisco, San Francisco, California, USA
  19. 19 Department of Rheumatology, Cairo University, Cairo, Egypt
  20. 20 Department of Medicine, Schroder Arthritis Institute, University Health Network, Toronto, Ontario, Canada
  21. 21 Duke-NUS, Singapore
  22. 22 Department of Neuromuscular Diseases, Centre for Rheumatology, University College London, London, UK
  23. 23 National Institute for Health Research, University College London Hospitals Biomedical Research Centre, University College London Hospitals NHS Foundation Trust, London, UK
  24. 24 Department of Rheumatology, Northwick Park Hospital, London North West University Healthcare NHS Trust, London, UK
  25. 25 Department of Medicine, University of Alberta, Edmonton, Alberta, Canada
  26. 26 Department of Rheumatology Global Medical Affairs, UCB Pharma, Brussels, Belgium
  27. 27 Division of Gastroenterology, Infectious Diseases and Rheumatology, Charité Universitätsmedizin Berlin, Berlin, Germany
  28. 28 Department of Gastroenterology, Infectiology and Rheumatology, Charite Universitatsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany
  29. 29 Department of Rheumatology, Zuyderland Medical Center, Heerlen, The Netherlands
  30. 30 Department of Immunology Clinical Development, Abbvie, North Chicago, Illinois, USA
  31. 31 Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands
  1. Correspondence to Dr Victoria Navarro-Compán, Rheumatology, La Paz University Hospital, Madrid, Madrid, Spain; mvictoria.navarroc{at}gmail.com

Abstract

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

https://doi.org/10.1136/annrheumdis-2022-222747

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    Footnotes

    • 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.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.