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$10,000 each). Dr. Cappelli has received consulting fees, speaking fees, and/or honoraria from AbbVie (less than $10,000) and research support from Bristol Myers Squibb. Dr. George has received honoraria from Paradigm Medical Communications (less than $10,000) and research support from Bristol Myers Squibb. Dr. Johnson has received consulting fees and/or honoraria from Boehringer Ingelheim and Ikaria (less than $10,000 each) and research support from GlaxoSmithKline, Corbus, Roche, Merck, Boehringer Ingelheim, and Bayer. No other disclosures relevant to this article were reported. Address correspondence to Liana Fraenkel, MD, MPH, 725 North Street, Pittsfield, MA 01201. Email: liana.fraenkel@yale.edu. Submitted for publication September 8, 2020; accepted in revised form March 15, 2021. 926 FRAENKEL ET AL | elibrary.wiley.com/doi/10.1002/acr.24596/abstract), includes a detailed description of the methods. Briefly, the core leadership team drafted clinical population, intervention, comparator, and outcomes (PICO) questions. The literature review team performed systematic literature reviews for the PICO questions, selected and evaluated individual studies and graded the quality of the body of evidence available for each outcome, and produced the evidence report that summarizes these assessments (see Supplementary Appendix 2, available on the Arthritis Care & Research website at http://onlinelibrary.wiley.com/doi/10.1002/acr.24596/abstract). The core team defined the critical study outcome as disease activity for most PICO questions. Because the ACR has, in a separate project, endorsed several disease activity measures for use in clinical practice, this guideline does not define levels of disease activity or the instruments a clinician should use to measure it (10). For PICO questions related to tapering, the critical outcomes were disease flare and subsequent return to the treatment target. Physical function, radiographic progression, quality of life, other patient-reported outcome measures, and adverse events were defined as important outcomes. Additional clinical outcomes were defined for PICO questions pertaining to select high-risk conditions (see Supplementary Appendix 3, available on the Arthritis Care & Research website at http://onlinelibrary.wiley.com/doi/10.1002/ acr.24596/abstract). When available, cost-effectiveness studies were included with the evidence reports. Cost estimates (average wholesale prices) were retrieved from Lexicomp (see Supplementary Appendix 4, available on the Arthritis Care & Research website at http://onlinelibrary.wiley.com/doi/10.1002/acr.24596/abstract). The panel considered these estimates from a societal perspective, i.e., based on the list price, and not the copay. An in-person panel of 10 patients with RA, moderated by the project’s principal investigator, reviewed the evidence report (along with a summary and interpretation by the moderator) and provided patient perspectives for consideration by the voting panel. The voting panel (13 clinicians and 2 patients) reviewed the evidence reports and patient perspectives and voted on recommendation statements. Rosters of the core leadership, literature review team, and panel members are listed in Supplementary Appendix 5, available on the Arthritis Care & Research website at http://online library.wiley.com/doi/10.1002/acr.24596/abstract. Several guiding principles, definitions, and assumptions were established a priori (Table 1). Because poor prognostic factors (11) have had less impact than other factors on prior RA treatment recommendations, they were not explicitly considered in formulating the PICO questions. However, poor prognostic factors were considered as possible
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