Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China

Jinjun Zhao, Taihe Zhan, Junqing Zhu, Meida Fan, Qin Huang, Hao Ren, Jing Wu, Qinghong Yu, Jingli Lin, Qingqing Ouyang, Shengli An, Min Yang, Jinjun Zhao, Taihe Zhan, Junqing Zhu, Meida Fan, Qin Huang, Hao Ren, Jing Wu, Qinghong Yu, Jingli Lin, Qingqing Ouyang, Shengli An, Min Yang

Abstract

Introduction: Rheumatoid arthritis (RA) is a chronic systemic disease and one of the most disabling diseases for patients. The American College of Rheumatology (ACR) issued a new guideline in 2015 for the treatment of RA based on the treat-to-target strategy to achieve better outcomes. This study will focus on the real-world rates of remission and low disease activity of patients with early RA in China, who will be treated according to the 2015 ACR guideline. Additionally, factors influencing treat-to-target outcomes will be analysed, and long-term prognosis and quality of life will be assessed.

Method and analysis: Two-hundred patients with early RA will be enrolled, treated and followed up once every 3 months for 48 months. These patients should fulfil the 2010 RA classification criteria of the ACR/European League Against Rheumatism with a disease course of no more than 6 months and should also fulfil other eligibility criteria. The patients will be treated following the 2015 ACR guideline. Their disease activity will be assessed, and they will be instructed to complete several questionnaires once every 3 months. The primary outcomes are the Disease Activity Score on 28 joints and Health Assessment Questionnaire Disability Index. The secondary outcome variables are the Simplified Disease Activity Index, Clinical Disease Activity Index and Routine Assessment of Patient Index Data 3 results, imaging data and personal medical costs. The data will be analysed using appropriate statistical analyses.

Ethics and dissemination: This research was approved by the Nanfang Hospital Ethics Committee (NFEC-2017-192). The results of the study will be published in international peer-reviewed journals.

Trial registration number: NCT03508713; Pre-results.

Keywords: 2015 ACR guideline; real-world; rheumatoid srthritis (RA); treat-to-target.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
2015 ACR RA treatment recommendations. The 2015 ACR recommendations for the treatment of early RA, which is defined as a disease duration 

References

    1. Frisell T, Saevarsdottir S, Askling J. Family history of rheumatoid arthritis: an old concept with new developments. Nat Rev Rheumatol 2016;12:335–43. 10.1038/nrrheum.2016.52
    1. Li R, Sun J, Ren LM, et al. . Epidemiology of eight common rheumatic diseases in China: a large-scale cross-sectional survey in Beijing. Rheumatology 2012;51:721–9. 10.1093/rheumatology/ker370
    1. Jin S, Li M, Fang Y, et al. . Chinese Registry of rheumatoid arthritis (CREDIT): II. prevalence and risk factors of major comorbidities in Chinese patients with rheumatoid arthritis. Arthritis Res Ther 2017;19:251 10.1186/s13075-017-1457-z
    1. Dai SM, Han XH, Zhao DB, et al. . Prevalence of rheumatic symptoms, rheumatoid arthritis, ankylosing spondylitis, and gout in Shanghai, China: a COPCORD study. J Rheumatol 2003;30:2245–51.
    1. Ozminkowski RJ, Burton WN, Goetzel RZ, et al. . The impact of rheumatoid arthritis on medical expenditures, absenteeism, and short-term disability benefits. J Occup Environ Med 2006;48:135–48. 10.1097/01.jom.0000194161.12923.52
    1. Wang G, Mu R, Xu H. Management of rheumatoid arthritis in People’s Republic of China - focus on tocilizumab and patient considerations. Int J Gen Med 2015;8:187–94. 10.2147/IJGM.S81633
    1. Singh JA, Saag KG, Bridges SJ, et al. . American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol 2015;2016:1–26.
    1. Anderson J, Caplan L, Yazdany J, et al. . Rheumatoid arthritis disease activity measures: American College of Rheumatology recommendations for use in clinical practice. Arthritis Care Res 2012;64:640–7. 10.1002/acr.21649
    1. McInnes IB, O’Dell JR. State-of-the-art: rheumatoid arthritis. Ann Rheum Dis 2010;69:1898–906. 10.1136/ard.2010.134684
    1. Smolen JS, Landewe R, Breedveld FC, et al. . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010;69:964–75. 10.1136/ard.2009.126532
    1. Klarenbeek NB, Güler-Yüksel M, van der Kooij SM, et al. . The impact of four dynamic, goal-steered treatment strategies on the 5-year outcomes of rheumatoid arthritis patients in the BeSt study. Ann Rheum Dis 2011;70:1039–46. 10.1136/ard.2010.141234
    1. Singh JA, Furst DE, Bharat A, et al. . 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res 2012;64:625–39. 10.1002/acr.21641
    1. Smolen JS, Landewé R, Breedveld FC, et al. . EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis 2014;73:492–509. 10.1136/annrheumdis-2013-204573
    1. Plant MJ, Jones PW, Saklatvala J, et al. . Patterns of radiological progression in early rheumatoid arthritis: results of an 8 year prospective study. J Rheumatol 1998;25:417–26.
    1. van der Heijde DM, van Riel PL, van Leeuwen MA, et al. . Older versus younger onset rheumatoid arthritis: results at onset and after 2 years of a prospective followup study of early rheumatoid arthritis. J Rheumatol 1991;18:1285–9.
    1. Emery P, Hammoudeh M, FitzGerald O, et al. . Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med 2014;371:1781–92. 10.1056/NEJMoa1316133
    1. Wang GY, Zhang SL, Wang XR, et al. . Remission of rheumatoid arthritis and potential determinants: a national multi-center cross-sectional survey. Clin Rheumatol 2015;34:221–30. 10.1007/s10067-014-2828-3
    1. Kay J, Upchurch KS. ACR/EULAR 2010 rheumatoid arthritis classification criteria. Rheumatology 2012;51 Suppl 6:vi5–vi9. 10.1093/rheumatology/kes279

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться