Patient outcomes improve when a molecular signature test guides treatment decision-making in rheumatoid arthritis

References

• CfDCa P. Rheumatoid Arthritis (RA) July 27, 2020 [2022 Jun 28]. Available from: www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html
   Google Scholar
• Jin Y, Desai RJ, Liu J, et al. Factors associated with initial or subsequent choice of biologic disease-modifying antirheumatic drugs for treatment of rheumatoid arthritis. Arthritis Res Ther. 2017 Jul 5 19(1):159.
   PubMedGoogle Scholar
• Curtis JR, Zhang J, Xie F, et al. Use of oral and subcutaneous methotrexate in rheumatoid arthritis patients in the United States. Arthritis Care Res (Hoboken). 2014 Nov;66(11):1604–1611.
   PubMed Web of Science ®Google Scholar
• Curtis JR, Jain A, Askling J, et al. A comparison of patient characteristics and outcomes in selected European and U.S. rheumatoid arthritis registries. Semin Arthritis Rheum. 2010 Aug;40(1):2–14 e1.
   PubMed Web of Science ®Google Scholar
• Mellors T, Withers JB, Ameli A, et al. Clinical validation of a blood-based predictive test for stratification of response to tumor necrosis factor inhibitor therapies in rheumatoid arthritis patients. Netw syst med. 2020;3(1):91–104.
   Google Scholar
• Cohen S, Wells AF, Curtis JR, et al. A molecular signature response classifier to predict inadequate response to tumor necrosis factor-alpha inhibitors: the NETWORK-004 prospective observational study. Rheumatol Ther. 2021 Sep;8(3):1159–1176.
   PubMed Web of Science ®Google Scholar
• Strand V, Cohen SB, Curtis JR, et al. Clinical utility of therapy selection informed by predicted nonresponse to tumor necrosis factor-a inhibitors: an analysis from the Study to Accelerate Information of Molecular Signatures (AIMS) in rheumatoid arthritis. Expert Rev Mol Diagn. 2021 Dec;30:1–9.
   Google Scholar
• Strand V, Zhang L, Arnaud A, et al. Improvement in clinical disease activity index when treatment selection is informed by the tumor necrosis factor-a inhibitor molecular signature response classifier: analysis from the study to accelerate information of molecular signatures in rheumatoid arthritis. Expert Opin Biol Ther. 2022 Jun;22(6):801–807.
   PubMed Web of Science ®Google Scholar
• Patel D, Grimson F, Mihaylova E, et al. Use of external comparators for health technology assessment submissions based on single-arm trials. Value Health. 2021 Aug;24(8):1118–1125.
   PubMed Web of Science ®Google Scholar
• Jahanshahi M, Gregg K, Davis GH, et al. The external controls in FDA regulatory decision making. Ther Innov Regul Sci. 2021Sep;55:1019–1035.
   PubMed Web of Science ®Google Scholar
• Curtis JR, Xie F, Zhou H, et al. Use of ICD-10 diagnosis codes to identify seropositive and seronegative rheumatoid arthritis when lab results are not available. Arthritis Res Ther. 2020 Oct 15 22(1):242.
   PubMed Web of Science ®Google Scholar
• Jones A, Rapisardo S, Zhang L, et al. Analytical and clinical validation of an RNA sequencing-based assay for quantitative, accurate evaluation of a molecular signature response classifier in rheumatoid arthritis. Expert Rev Mol Diagn. 2021 Nov;21(11):1235–1243.
   PubMed Web of Science ®Google Scholar
• Curtis J, Yang S, Chen L, et al. Determining the minimally important difference in the clinical disease activity index for improvement and worsening in early rheumatoid arthritis patients. Arthritis Care Res (Hoboken). 2015;67(10):1345–1353. 2015.
   PubMed Web of Science ®Google Scholar
• Austin PC An Introduction to Propensity Score Methods for Reducing the Effects of Confounding in Observational Studies. Multivariate Behav Res. 2011 May;46:399–424 10.1080/00273171.2011.568786
   PubMed Web of Science ®Google Scholar
• Austin PC. Statistical criteria for selecting the optimal number of untreated subjects matched to each treated subject when using many-to-one matching on the propensity score. Am J Epidemiol. 2010 Nov 1; 172(9):1092–1097.
   PubMed Web of Science ®Google Scholar
• Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011 May;46(3):399–424.
   PubMed Web of Science ®Google Scholar
• Crump RK, Hotz VJ, Imbens GW, et al. Dealing with limited overlap in estimation of average treatment effects. Biometrika. 2009;96(1):187–199.
   Web of Science ®Google Scholar
• Funk MJ, Westreich D, Wiesen C, et al. Doubly robust estimation of causal effects. Am J Epidemiol. 2011 Apr 1 173(7):761–767.
   PubMed Web of Science ®Google Scholar
• Zhang Z, Kim HJ, Lonjon G, et al. Balance diagnostics after propensity score matching. Ann Transl Med. 2019;7(1):16.
   PubMed Web of Science ®Google Scholar
• Meehan RT, Amigues IA, Knight V. Precision medicine for rheumatoid arthritis: the right drug for the right patient-companion diagnostics. Diagnostics (Basel). 2021 Jul 29;118. Doi:10.3390/diagnostics11081362
   PubMedGoogle Scholar
• Arnell C, Bergman M, Basu D, et al. Guided therapy selection in rheumatoid arthritis using a molecular signature response classifier: an assessment of budget impact and clinical utility. J Manag Care Spec Pharm. 2021;20:1–9.
   Google Scholar
• Gwinnutt JM, Leggett S, Lunt M, et al. Predictors of presenteeism, absenteeism and job loss in patients commencing methotrexate or biologic therapy for rheumatoid arthritis. Rheumatology (Oxford). 2020 Oct 1 59(10):2908–2919.
   PubMed Web of Science ®Google Scholar
• Druce KL, Aikman L, Dilleen M, et al. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29 20(1):96.
   PubMedGoogle Scholar
• Nikiphorou E, Norton S, Young A, et al. Association between rheumatoid arthritis disease activity, progression of functional limitation and long-term risk of orthopaedic surgery: combined analysis of two prospective cohorts supports EULAR treat to target DAS thresholds. Ann Rheum Dis. 2016 Dec;75(12):2080–2086.
   PubMed Web of Science ®Google Scholar
• Pappas DA, Brittle C, Mossell JE, et al. Perceived clinical utility of a test for predicting inadequate response to TNF inhibitor therapies in rheumatoid arthritis: results from a decision impact study. Rheumatol Int. 2020;41(3):585–593.
   PubMed Web of Science ®Google Scholar
• Smolen JS, Landewe RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):685–699.
   PubMed Web of Science ®Google Scholar
• Fraenkel L, Bathon JM, England BR, et al. 2021 American college of rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken). 2021 Jul;73(7):924–939.
   PubMed Web of Science ®Google Scholar
• Bodio C, Grossi C, Pregnolato F, et al. Personalized medicine in rheumatoid arthritis: how immunogenicity impacts use of TNF inhibitors. Autoimmun Rev. 2020 May;19(5):102509.
   PubMed Web of Science ®Google Scholar
• Mehta P, Manson JJ. What is the clinical relevance of TNF inhibitor immunogenicity in the management of patients with rheumatoid arthritis? Front Immunol. 2020;11:589.
   PubMed Web of Science ®Google Scholar
• van Eijk IC, Nielen MM, van der Horst-Bruinsma I, et al. Aggressive therapy in patients with early arthritis results in similar outcome compared with conventional care: the STREAM randomized trial. Rheumatology (Oxford). 2012 Apr;51(4):686–694.
   PubMed Web of Science ®Google Scholar
• Urata Y, Uesato R, Tanaka D, et al. Treating to target matrix metalloproteinase 3 normalisation together with disease activity score below 2.6 yields better effects than each alone in rheumatoid arthritis patients: t-4 study. Ann Rheum Dis. 2012 Apr;71(4):534–540.
   PubMed Web of Science ®Google Scholar
• Lindstrom TM, Robinson WH. Biomarkers for rheumatoid arthritis: making it personal. Scand J Clin Lab Invest Suppl. 2010;242(sup242):79–84.
   PubMedGoogle Scholar
• Robinson WH, Mao R. Biomarkers to guide clinical therapeutics in rheumatology? Curr Opin Rheumatol. 2016 Mar;28(2):168–175.
   PubMed Web of Science ®Google Scholar
• van Schaardenburg D, Dijkmans BA. Clinical approaches to early inflammatory arthritis. Nat Rev Rheumatol. 2009 Nov;5(11):627–633.
   PubMed Web of Science ®Google Scholar
• Ermann J, Rao DA, Teslovich NC, et al. Immune cell profiling to guide therapeutic decisions in rheumatic diseases. Nat Rev Rheumatol. 2015 Sep;11(9):541–551.
   PubMed Web of Science ®Google Scholar
• Evans RS. Electronic health records: then, Now, and in the future. Yearb Med Inform. 2018;25:S48–S61.
   Google Scholar
• Casey JA, Schwartz BS, Stewart WF, et al. Using electronic health records for population health research: a review of methods and applications. Annu Rev Public Health. 2016;37(1):61–81.
   PubMedGoogle Scholar