SUPPLEMENTARY APPENDIX 6: Evidence Report 2019 Update of the American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network Recommendations for the Treatment of Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis Literature Review Members Liron Caplan MD, PhD; Literature Review Lead Marat Turgunbaev MD, MPH Jeff Oristaglio PhD Amit Aakash Shah MD, MPH Nancy Sullivan, BA Walter Maksymowych, MD, FRCPC Core Oversight Team Michael Ward, MD, MPH; Principal Investigator Liron Caplan MD, PhD Atul Deodhar, MD, MRCP ACR Staff Amy Miller; Senior Director, Quality Janet M. Waters, MLS, MLS, BSN, RN, CWCN Regina Parker PICO-specific instructions for the Voting Panel appear in italics below each PICO. Citations in this document appear as: AuthorLastName year [Citation#] where AuthorLastName = last name of the first author for the reference year = year of publication (generally, the print publication) [Citation#] = bibliographic number of the citation in the reference list at the end of this evidence report document Notes GRADE Working Group grades of evidence definitions Very low quality: We are very uncertain about the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. High quality: Further research is very unlikely to change our confidence in the estimate of effect. Abbreviations Adverse Event = a medication “side-effect” GL = guidelines Acute Phase Reactant = blood test for inflammation IBD = inflammatory bowel disease AS = ankylosing spondylitis HHS = Harris Hip Score (assesses functional status, pain, and ROM ASDAS = Ankylosing Spondylitis Disease Activity Score related to hip in order to assess surgical outcomes) ASQOL = Ankylosing Spondylitis Quality of Life instrument MD = mean difference (the absolute difference between axSpA = axial spondyloarthritis intervention and control groups or between baseline and BASDAI = Bath Ankylosing Spondylitis Disease Activity Index final values for a measurement, such as the BASDAI or BASFI = Bath Ankylosing Spondylitis Functional Index BASFI) BASMI = Bath Ankylosing Spondylitis Metrology Index (a composite mNY = modified New York Classification Criteria for ankylosing measure of range of motion for the central skeleton) spondylitis (van der Linden 1984)[2] CI’s = confidence intervals nr-AxSpA – non-radiographic axial spondyloarthritis CRP = c-reactive protein (blood test for inflammation) NR = not reported DFI = Dougados Functional Index PICO = Patient/Intervention/Comparison/Outcome formatted ESSG = European Spondyloarthropathy Study Group criteria question used in the GRADE system (Dougados 1991)[1] PsA = psoriatic arthritis FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue pts = patients FEV = forces expiratory volume; a test of lung function SD’s = standard deviations F/U = follow up RCT = randomized controlled trial GI = gastrointestinal 2 Table of Contents 2018 Update to 2015 Guidelines ...................... 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PICO 72 .......................................................................................................... 44 Notes ............................................................................................................... 2 PICO 60 .......................................................................................................... 45 PICO 1 .............................................................................................................. 4 PICO 73 .......................................................................................................... 45 PICO 33 ............................................................................................................ 6 PICO 61 .......................................................................................................... 46 PICO 5 .............................................................................................................. 7 PICO 74 .......................................................................................................... 46 PICO 37 .......................................................................................................... 10 PICO 62 .......................................................................................................... 47 PICO 6 ............................................................................................................ 11 PICO 75 .......................................................................................................... 47 PICO 38 .......................................................................................................... 15 PICO 63 .......................................................................................................... 48 PICO 7 ............................................................................................................ 18 PICO 76 .......................................................................................................... 49 PICO 39 .......................................................................................................... 26 PICO 64 .......................................................................................................... 50 PICO 8 ............................................................................................................ 27 PICO 77 .......................................................................................................... 54 PICO 40 .......................................................................................................... 32 PICO 65 .......................................................................................................... 55 PICO 9 ............................................................................................................ 33 PICO 78 .......................................................................................................... 61 PICO 41 .......................................................................................................... 34 PICO 66 .......................................................................................................... 61 PICO 10 .......................................................................................................... 35 PICO 79 .......................................................................................................... 63 PICO 42 .......................................................................................................... 35 PICO 67 .......................................................................................................... 64 PICO 11 .......................................................................................................... 36 PICO 80 .......................................................................................................... 65 PICO 43 .......................................................................................................... 36 PICO 68 .......................................................................................................... 66 PICO 12 .......................................................................................................... 37 PICO 81 .......................................................................................................... 66 PICO 44 .......................................................................................................... 37 PICO 69 .......................................................................................................... 67 PICO 29 .......................................................................................................... 38 PICO 82 .......................................................................................................... 68 PICO 32 .......................................................................................................... 40 PICO 70 .......................................................................................................... 69 PICO 58 .......................................................................................................... 42 PICO 83 .......................................................................................................... 70 PICO 71 .......................................................................................................... 43 Bibliography .................................................................................................. 72 PICO 59 .......................................................................................................... 44 3 PICO 1: In adults with active or stable AS, is continuous treatment with NSAIDs more effective than on-demand treatment with NSAIDs in improving outcomes? Guidance to voters: If your vote is different for active and stable disease, vote only for active disease and we will adjust the PICO next time. Please note this in your comments. Summary: This PICO was directly addressed by 2 RCTs. The first was included in the 2015 axSpA GL: a 2-year open-label (patients unblinded) study (Wanders 2005)[3]. All patients in this study began treatment with celecoxib (100 mg twice daily), but patients were permitted to increase this dosage to 200 mg twice daily or