Response to Treatment with Intravenous Golimumab or Infliximab in Rheumatoid Arthritis Patients: PROMIS Results from the Real-World Observational Phase 4 AWARE Study

Sparks JA. Rheumatoid arthritis. Ann Intern Med. 2019;170:ITC1-ITC16. 

Article  PubMed  Google Scholar 

Bullock J, Rizvi SAA, Saleh AM, Ahmed SS, Do DP, Ansari RA, et al. Rheumatoid arthritis: a brief overview of the treatment. Med Princ Pract. 2018;27:501–7.

Article  PubMed  PubMed Central  Google Scholar 

Fautrel B, Alten R, Kirkham B, de la Torre I, Durand F, Barry J, et al. Call for action: how to improve use of patient-reported outcomes to guide clinical decision making in rheumatoid arthritis. Rheumatol Int. 2018;38:935–47.

Article  PubMed  PubMed Central  Google Scholar 

Jones B, Flurey CA, Proudman S, Ferreira RJO, Voshaar M, Hoogland W, et al. Considerations and priorities for incorporating the patient perspective on remission in rheumatoid arthritis: an OMERACT 2020 special interest group report. Semin Arthritis Rheum. 2021;51:1108–12. 

Article  PubMed  Google Scholar 

Boers M, Tugwell P, Felson DT, van Riel PL, Kirwan JR, Edmonds JP, et al. World Health Organization and International League of Associations for Rheumatology core endpoints for symptom modifying antirheumatic drugs in rheumatoid arthritis clinical trials. J Rheumatol Suppl. 1994;41:86–9.

CAS  PubMed  Google Scholar 

Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum. 1993;36:729–40.

Article  CAS  PubMed  Google Scholar 

Kirwan JR, Minnock P, Adebajo A, Bresnihan B, Choy E, de Wit M, et al. Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis. J Rheumatol. 2007;34:1174–7.

PubMed  Google Scholar 

Sanderson T, Morris M, Calnan M, Richards P, Hewlett S. Patient perspective of measuring treatment efficacy: the rheumatoid arthritis patient priorities for pharmacologic interventions outcomes. Arthritis Care Res. 2010;62:647–56.

Article  CAS  Google Scholar 

Bartlett SJ, Hewlett S, Bingham CO 3rd, Woodworth TG, Alten R, Pohl C, et al. OMERACT RA Flare Working Group. Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus. Ann Rheum Dis. 2012;71:1855–60.

Article  PubMed  Google Scholar 

Nowell WB, Gavigan K, Kannowski CL, Cai Z, Hunter T, Venkatachalam S, et al. Which patient-reported outcomes do rheumatology patients find important to track digitally? A real-world longitudinal study in ArthritisPower. Arthritis Res Ther. 2021;23:53.

Article  PubMed  PubMed Central  Google Scholar 

PROMIS®. Available at: https://www.healthmeasures.net/explore-measurement-systems/promis. Accessed 21 Mar 2022.

Khanna D, Krishnan E, Dewitt EM, Khanna PP, Spiegel B, Hays RD. The future of measuring patient-reported outcomes in rheumatology: Patient-Reported Outcomes Measurement Information System (PROMIS). Arthritis Care Res. 2011;63(Suppl 11):S486-490.

Article  Google Scholar 

Fries JF, Bruce B, Cella D. The promise of PROMIS: using item response theory to improve assessment of patient-reported outcomes. Clin Exp Rheumatol. 2005;23(5 Suppl 39):S53-57.

CAS  PubMed  Google Scholar 

Bartlett SJ, Orbai AM, Duncan T, DeLeon E, Ruffing V, Clegg-Smith K, et al. Reliability and validity of selected PROMIS measures in people with rheumatoid arthritis. PLoS ONE. 2015;10:e0138543.

Article  PubMed  PubMed Central  Google Scholar 

Bartlett SJ, Gutierrez AK, Andersen KM, Bykerk VP, Curtis JR, Haque UJ, et al. Identifying minimal and meaningful change in a Patient-Reported Outcomes Measurement Information System for rheumatoid arthritis: use of multiple methods and perspectives. Arthritis Care Res. 2022;74:588–97.

Article  Google Scholar 

Fries J, Rose M, Krishnan E. The PROMIS of better outcome assessment: responsiveness, floor and ceiling effects, and internet administration. J Rheumatol. 2011;38:1759–64.

Article  PubMed  Google Scholar 

Bingham CO, Gutierrez AK, Butanis A, Bykerk VP, Curtis JR, Leong A, et al. PROMIS fatigue short forms are reliable and valid in adults with rheumatoid arthritis. J Patient Rep Outcomes. 2019;3:14.

Article  Google Scholar 

Oude Voshaar MAH, ten Klooster PM, Glas CAW, Vonkeman HE, Taal E, Krishnan E, et al. Validity and measurement precision of the PROMIS physical function item bank and a content validity-driven 20-item short form in rheumatoid arthritis compared with traditional measures. Rheumatology. 2015;54:2221–9.

PubMed  Google Scholar 

Orbai AM, Bingham CO III. Patient reported outcomes in rheumatoid arthritis clinical trials. Curr Rheumatol Rep. 2015;17:28.

Article  PubMed  Google Scholar 

Wohlfahrt A, Bingham CO 3rd, Marder W, Phillips K, Bolster MB, Moreland LW, et al. Responsiveness of Patient-Reported Outcomes Measurement Information System measures in rheumatoid arthritis patients starting or switching a disease-modifying antirheumatic drug. Arthritis Care Res. 2019;71:521–9.

Article  CAS  PubMed  Google Scholar 

Crins MHP, Terwee CB, Westhovens R, van Schaardenburg D, Smits N, Joly J, et al. First validation of the full PROMIS pain interference and pain behavior item banks in patients with rheumatoid arthritis. Arthritis Care Res. 2020;72:1550–9.

Article  Google Scholar 

Bartlett SJ, De Leon E, Orbai AM, Haque UJ, Manno RL, Ruffing V, et al. Patient-reported outcomes in RA care improve patient communication, decision-making, satisfaction and confidence: qualitative results. Rheumatology. 2020;59:1662–70.

Article  PubMed  Google Scholar 

Yun H, Nowell WB, Curtis D, Willig JH, Yang S, Auriemma M, et al. Assessing rheumatoid arthritis disease activity with patient-reported outcomes measurement information system measures using digital technology. Arthritis Care Res. 2020;72:553–60.

Article  Google Scholar 

Curtis JR, Chakravarty SD, Black S, Kafka S, Xu S, Langholff W, et al. Incidence of infusion reactions and clinical effectiveness of intravenous golimumab versus infliximab in patients with rheumatoid arthritis: The real-world AWARE study. Rheumatol Ther. 2021;8:1551–63.

Article  PubMed  PubMed Central  Google Scholar 

Simponi ARIA. Package insert. Horsham: Janssen Biotech, Inc.; 2021.

Remicade: Package insert. Horsham, PA: Janssen Biotech, Inc.; 2020.

Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, et al. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005–2008. J Clin Epidemiol. 2010;63:1179–94.

Article  PubMed  PubMed Central  Google Scholar 

Aletaha D, Nell VPK, Stamm T, et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther. 2015;7:R796–806.

Article  Google Scholar 

Austin PC. A tutorial and case study in propensity score analysis: an application to estimating the effect of in-hospital smoking cessation counseling on mortality. Multivariate Behav Res. 2011;46:119–51.

Article  PubMed  PubMed Central  Google Scholar 

Meaningful Change for PROMIS®. Available at: https://www.healthmeasures.net/score-and-interpret/interpret-scores/promis/meaningful-change. Accessed 30 May 2022.

Beaumont JL, Davis ES, Fries JF, Curtis JR, Cella D, Yun H. Meaningful change thresholds for Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue and pain interference scores in patients with rheumatoid arthritis. J Rheumatol. 2021;48:1239–42.

Article  PubMed  Google Scholar 

Bingham CO III, Butanis AL, Orbai AM, Jones M, Ruffing V, Lyddiatt A, et al. Patients and clinicians define symptom levels and meaningful change for PROMIS pain interference and fatigue in RA using bookmarking. Rheumatol. 2021;60:4306–14.

Article  Google Scholar 

Terwee CB, Peipert JD, Chapman R, Lai JS, Terluin B, Cella D, et al. Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures. Qual Life Res. 2021;30:2729–54.

Article  PubMed  PubMed Central  Google Scholar 

Curtis JR, Su Y, Black S, Xu S, Langholff W, Bingham CO, et al. Machine learning applied to patient-reported outcomes to classify physician-derived measures of rheumatoid arthritis disease activity. ACR Open Rheumatol. 2022;4:995–1003.

Article  PubMed  PubMed Central  Google Scholar 

Delgado-Rodríguez M, Llorca J. Bias. J Epidemiol Community Health. 2004;58:635–41.

Article  Google Scholar 

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