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Abstract
Objective
The aim of this study was to examine how many Korean rheumatoid arthritis (RA) patients fulfilling the 2008 American College of Rheumatology (ACR) recommendation, 2007 British Society for Rheumatology (BSR) guideline and 2010 Japan College of Rheumatology (JCR) guideline for TNF-α blocker, meet the Korean National Health Insurance reimbursement criteria and to evaluate the reasons for failing the Korean National Health Insurance reimbursement criteria.
Methods
Data were obtained from a registry of RA patients who visited rheumatology clinics of Hallym university affiliated hospitals. Patients who were previously prescribed with methotrexate or leflunomide for more than 3 months and had at least one DAS28 examination were included in the present study.
Results
Of 642 patients included, 118 episodes meeting ACR guideline for using TNF-α blocker were identified in 88 patients (13.7%). In addition, 19 episodes meeting BSR guideline in 17 patients (2.6%) and 21 episodes meeting JCR guideline in 21 patients (6.2%) were identified. Four episodes (4.8%) meeting ACR recommendation, 0 episodes meeting BSR criteria and 5 episodes (12%) meeting JCR criteria, respectively, were eligible for TNF-α blocker according to the Korean National Health Insurance reimbursement guideline. The most common reason for failing the Korean National Health Insurance reimbursement criteria was the number of active joint counts (92.6%).
Figures and Tables
Figure 1
Recruitment of rheumatoid arthritis (RA) study participants. MTX: Methotrexate, LFN: Leflumonide, DAS28: Disease activity score 28, ACR: American College of Rheumatology, BSR: British Society for Rheumatology, JCR: Japan College of Rheumatology.
Figure 2
Responses to questionnaires about the Korean National Health Insurance reimbursement criteria for TNF-α blocker in patients with rheumatoid arthritis. (A) Overall rating on the Korean National Health Insurance reimbursement criteria (B) Each reimbursement criteria selected as the most unreasonable. *Acute phase reactant: ESR≥28 mm/hr or CRP≥2 mg/dL, †Morning stiffness: more than 45 minutes, ‡Active joint count: more than 20 total active joint counts or total 6 active joint counts with more 4 active joint count in large joints, §Previous treatment Hx: inadequate control despite treatment for at least 3 months respectively with 2 more DMARDs.
Table 1
Characteristics of the study subjects satisfying ACR, BSR and JCR guidelines for TNF-α blocker in rheumatoid arthritis
ACR: American College of Rheumatology, BSR: British Society for Rheumatology, JCR: Japan College of Rheumatolgy, RF: rheumatoid factor, ACPA: anti-citrullinated protein antibody, baseline ESR: erythrocyte sedimentation rate at the start of treatment, baseline CRP: C-reactive protein at the start of treatment. *N: number of patient satisfying each national guideline for TNF-α blocker, Data are expressed as mean±standard deviation, unless specified otherwise
Table 3
Profiles of DAS28 in study subjects at the time of satisfying ACR, BSR and JCR guidelines for TNF-α blocker in rheumatoid arthritis
ACR: American College of Rheumatology, BSR: British Society for Rheumatology, JCR: Japan College of Rheumatology, DAS28: disease activity score 28, SJC: swollen joint count, TJC: tender joint count, ESR: erythrocyte sedimentation rate, CRP: C-reactive protein, *episode: number of clinic visit fulfilling each national guideline for TNF-α blocker in rheumatoid arthritis, †Active joint: swollen and tender joint within one joint, ‡Large joints: both shoulder, hip, knee, ankle, elbow, wrist
References
1. Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. T2T Expert Committee. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010. 69:631–637.
2. Song JS. Review of tumor necrosis factor inhibitors on rheumatoid arthritis. J Korean Rheum Assoc. 2007. 14:1–14.
3. Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept therapy in rheumatoid arthritis. A randomized, controlled trial. Ann Intern Med. 1999. 130:478–486.
4. Maini RN, Breedveld FC, Kalden JR, Smolen JS, Davis D, Macfarlane JD, et al. 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. 1998. 41:1552–1563.
5. Weinblatt ME, Keystone EC, Furst DE, Moreland LW, Weisman MH, Birbara CA, et al. 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. 2003. 48:35–45.
6. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR, et al. American College of Rheumatology. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. 2008. 59:762–784.
7. Ledingham J, Deighton C. British Society for Rheumatology Standards, Guidelines and Audit Working Group. Update on the British Society for Rheumatology guidelines for prescribing TNFalpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001). Rheumatology (Oxford). 2005. 44:157–163.
8. Koike R, Takeuchi T, Eguchi K, Miyasaka N. Japan College of Rheumatology. Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007. 17:451–458.
9. Smolen JS, Landewé R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2010. 69:964–975.
10. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. The PREMIER study: A multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 2006. 54:26–37.
11. Emery P, Breedveld FC, Hall S, Durez P, Chang DJ, Robertson D, et al. Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial. Lancet. 2008. 372:375–382.
12. Kuriya B, Arkema EV, Bykerk VP, Keystone EC. Efficacy of initial methotrexate monotherapy versus combination therapy with a biological agent in early rheumatoid arthritis: a meta-analysis of clinical and radiographic remission. Ann Rheum Dis. 2010. 69:1298–1304.
13. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, 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 (Hoboken). 2012. 64:625–639.
14. Fautrel B, Flipo RM, Saraux A. Eligibility of rheumatoid arthritis patients for anti-TNF-alpha therapy according to the 2005 recommendations of the French and British Societies for Rheumatology. Rheumatology (Oxford). 2008. 47:1698–1703.
15. Geens E, Geusens P, Vanhoof J, Berghs H, Praet J, Esselens G, et al. Belgian rheumatologists' perception on eligibility of RA patients for anti-TNF treatment matches more closely Dutch rather than Belgian reimbursement criteria. Rheumatology (Oxford). 2009. 48:546–550.
16. Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010. 62:2569–2581.
17. Ranzolin A, Brenol JC, Bredemeier M, Guarienti J, Rizzatti M, Feldman D, et al. Association of concomitant fibromyalgia with worse disease activity score in 28 joints, health assessment questionnaire, and short form 36 scores in patients with rheumatoid arthritis. Arthritis Rheum. 2009. 61:794–800.
18. Lee JH, Cho SK, Choi CB, Sung YK, Bae SC. Impact of change in reimbursement guideline of rheumatoid arthritis on the short term persistence of tumor necrosis factor (TNF) blockers. J Rheum Dis. 2011. 18:283–287.
19. Cho SK, Sung YK, Choi CB, Bae SC. Impact of comorbidities on TNF inhibitor persistence in rheumatoid arthritis patients: an analysis of Korean National Health Insurance claims data. Rheumatol Int. 2011. [Epub ahead of print].
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