Simplified disease activity changes in real-world practice: a nationwide observational study of seropositive rheumatoid arthritis patients with moderate-to-high disease activity
2
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
Background/Aims: The objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheumatoid arthritis (RA) in daily clinical practice. Methods: This was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Serial SDAI changes and clinical remission rate at 6 and 12 months were assessed. Results: A total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was –19.0 in the bDMARD group and –12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, respectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission. Conclusions: There was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.
Abstract
Background/Aims: The objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheumatoid arthritis (RA) in daily clinical practice. Methods: This was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Serial SDAI changes and clinical remission rate at 6 and 12 months were assessed. Results: A total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was –19.0 in the bDMARD group and –12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, respectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission. Conclusions: There was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.
참고문헌 (26)
- Scott DL, "Long-term outcome of treating rheumatoid arthritis : results after 20 years", Lancet, 1, pp.1108~1111 (1987)
- Isomaki H, "Long-term outcome of rheumatoid arthritis", Scand J Rheumatol Suppl, 95, pp.3~8 (1992)
- Sung YK, "Prevalence and incidence of rheumatoid arthritis in South Korea", Rheumatol Int, 33, pp.1525~1532 (2013)
- Pressman Lovinger S, "Use of biologics for rheumatoid arthritis tempered by concerns over safety, cost", JAMA, 289, pp.3229~3230 (2003)
- Scott DL, "Tumor necrosis factor inhibitors for rheumatoid arthritis", N Engl J Med, 355, pp.704~712 (2006)
- Maini RN, "Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis", Arthritis Rheum, 41, pp.1552~1563 (1998)
- Weinblatt ME, "Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate : the ARMADA trial", Arthritis Rheum, 48, pp.35~45 (2003)
- Keystone EC, "Once-weekly administration of 50 mg etanercept in patients with active rheumatoid arthritis : results of a multicenter, randomized, double-blind, placebo-controlled trial", Arthritis Rheum, 50, pp.353~363 (2004)
- Keystone EC, "Golimumab, a human antibody to tumour necrosis factor {alpha}given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy : the GO-FORWARD Study", Ann Rheum Dis, 68, pp.789~796 (2009)
- Maini R, "Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group", Lancet, 354, pp.1932~1939 (1999)
- McKeage K, "A review of CT-P13 : an infliximab biosimilar", BioDrugs, 28, pp.313~321 (2014)
- Ravindran V, "A systematic review and meta-analysis of efficacy and toxicity of disease modifying anti-rheumatic drugs and biological agents for psoriatic arthritis", Ann Rheum Dis, 67, pp.855~859 (2008)
- Furst DE, "Observational cohort studies and well controlled clinical trials: we need them both!", J Rheumatol, 31, pp.1476~1477 (2004)
- Pincus T, "Should contemporary rheumatoid arthritis clinical trials be more like standard patient care and vice versa", Ann Rheum Dis, 63(Suppl 2), pp.ii32~ii39 (2004)
- Krishnan E, "Measuring effectiveness of drugs in observational databanks : promises and perils", Arthritis Res Ther, 6, pp.41~44 (2004)
- Sokka T, "Eligibility of patients in routine care for major clinical trials of anti-tumor necrosis factor alpha agents in rheumatoid arthritis", Arthritis Rheum, 48, pp.313~318 (2003)
- Sokka T, "Most patients receiving routine care for rheumatoid arthritis in 2001 did not meet inclusion criteria for most recent clinical trials or American College of Rheumatology criteria for remission", J Rheumatol, 30, pp.1138~1146 (2003)
- Bombardier C, "Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies?", Ann Rheum Dis, 58(Suppl 1), pp.I82~I85 (1999)
- Aletaha D, "2010 Rheumatoid arthritis classification criteria : an American College of Rheumatology", European League Against Rheumatism collaborative initiative, 2010, pp.62, 2569~2581
- Felson DT, "American College of Rheumatology", European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials, 2011, pp.63, 573~586
- Hur JW, "Rheumatoid arthritis patients fulfilling Korean National Health Insurance reimbursement guidelines for anti-tumor necrosis factor-αtreatment and comparison to other guidelines", Rheumatol Int, 35, pp.1817~1823 (2015)
- Singh JA, "2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis", Arthritis Rheumatol, 68, pp.1~26 (2016)
- Hyrich KL, "Predictors of response to anti-TNF-alpha therapy among patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register", Rheumatology(Oxford), 45, pp.1558~1565 (2006)
- Anderson JJ, "Factors predicting response to treatment in rheumatoid arthritis : the importance of disease duration", Arthritis Rheum, 43, pp.22~29 (2000)
- Zink A, "Treatment continuation in patients receiving biological agents or conventional DMARD therapy", Ann Rheum Dis, 64, pp.1274~1279 (2005)
- Hetland ML, "Direct comparison of treatment responses, remission rates, and drug adherence in patients with rheumatoid arthritis treated with adalimumab, etanercept, or infliximab: results from eight years of surveillance of clinical practice in the nationwide Danish DANBIO registry", Arthritis Rheum, 62, pp.22~32 (2010)
