Rheumatoid arthritis treatment with TNF inhibitors and alternative procedures in case of its failure – results of the Polish survey in the context of EULAR recommendations
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Submission date: 2014-12-17
Final revision date: 2015-07-13
Acceptance date: 2015-08-20
Online publication date: 2015-09-22
Publication date: 2015-09-15
Reumatologia 2015;53(4):200–206
Introduction: According to the European League Against Rheumatism (EULAR), rheumatoid arthritis (RA) treatment aims to achieve remission or low disease activity (LDA) within 6 months. In Poland, despite the existence of the National Health Fund Drug Program (NHF-DP), data on the effects of treatment with biological agents in patients with RA are not publicly available. Also we cannot compare registers from other countries with the Polish results because the rules of the therapeutic program in Poland impose restrictions that do not exist in other countries. For this reason, the data will not be comparable, but the results of the currently used regimen for biological treatment in Poland should be analyzed and compared with the recommendations of the European EULAR as a contribution to further discussion.
Objectives: To determine the tumor necrosis factor α (TNF-α) inhibitor treatment patterns in RA patients in Poland, to evaluate the frequency and causes of treatment failure as well as post-failure recommendations, and to compare Polish clinical practice enforced by the therapeutic program with the EULAR recommendations.
Material and methods: The data on 895 RA patients were retrospectively collected from routine medical records. A questionnaire was completed only once for each patient.
Results: After 3 months of treatment with a TNF-α inhibitor, the therapeutic target was achieved in 72% of patients: 4% in remission, 8% LDA, and 60% with moderate disease activity (MDA); after 9 months, 46% had reached the target: 16% in remission, 30% with LDA. An average of 49% of patients presented with MDA or high disease activity (HDA), thus requiring treatment modification. Treatment failure was confirmed in 14% of patients and a modified therapy administered: rituximab (72%) or adalimumab (20%). The most common cause of failure was inefficacy of treatment (70%).
Conclusions: In the Polish therapeutic program, despite the persistence of MDA or HDA, the treatment with TNF inhibitors rarely qualifies as ineffective and therefore is seldom modified by switching to another biologic drug. As long as the initiation of treatment and its modifications are enforced by the NHF-DP and not the recommendations of EULAR, treatment may be less effective and paradoxically cost-intensive. Therefore, it seems obvious that it is necessary to change and adapt the NHF-DP requirements to European standards.
Listing J, Strangfeld A, Rau R, et al. Clinical and functional remission: even though biologics are superior to conventional DMARDs overall success rates remain low-results from RABBIT, the German biologics register. Arthritis Res Ther 2006; 8: R66. .
Wick MC, Ernestam S, Lindblad S, et al. Adalimumab (Humira) restores clinical response in patients with secondary loss of efficacy from infliximab (Remicade) or etanercept (Enbrel): results from the STURE registry at Karolinska University Hospital. Scand J Rheumatol 2005; 34: 353-358. .
Hjardem E, Østergaard M, Pødenphant J, et al. Do rheumatoid arthritis patients in clinical practice benefit from switching from infliximab to a second tumor necrosis factor alpha inhibitor? Ann Rheum Dis 2007; 66: 1184-1189. .
Smolen JS, Aletaha D, Bijlsma JWJ, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis 2010; 69: 631-637. .
Smolen J, Landewé R, Breedveld F, 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. .
National Health Fund Drug Program 2012. Treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis (JIA) with aggressive course [in Polish]. Annex 16 to Regulation No. 59/2011/DGL Chairman of the National Health Fund, 10 October 2011. Available at: http://www.nfz-lodz.pl/attachm....
Van Cestel A, Prevoo M, van’t Hof M, et al. Development and validation of the European League Against Rheumatism response criteria for rheumatoid arthritis. Arthritis Rheum 1996; 39: 34-40. .
Prevoo ML, van't Hof MA, Kuper HH, et al. Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis. Arthritis Rheum 1995; 38: 44-48. .
Hetland ML. DANBIO-powerful research database and electronic patient record. Rheumatology (Oxford) 2011; 50: 69-77. .
Marchesoni A, Zaccara E, Gorla R, et al. TNF-αlpha antagonist survival rate in a cohort of rheumatoid arthritis patients observed under conditions of standard clinical practice. Ann N Y Acad Sci 2009; 1173: 837-846. .
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 (Hoboken) 2012; 64: 625-639. .
van Vollenhoven R, Harju A, Brannemark S, et al. Treatment with infliximab (Remicade) when etanercept (Enbrel) has failed or vice versa: data from the STURE registry showing that switching tumour necrosis factor alpha blockers can make sense. Ann Rheum Dis 2003; 62: 1195-1198. .
Hyrich KL, Lunt M, Dixon WG, et al. Effects of switching between anti-TNF therapies on HAQ response in patients who do not respond to their first anti-TNF drug. Rheumatology (Oxford) 2008; 47: 1000-1005. .
Hyrich KL, Lunt M, Watson KD, et al. Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study. Arthritis Rheum 2007; 56: 13-20. .
Greenberg JD, Reed G, Decktor D, et al. A comparative effectiveness study of adalimumab, etanercept and infliximab in biologically naive and switched rheumatoid arthritis patients: results from the US CORRONA registry. Ann Rheum Dis 2012; 71: 1134-1142. .
Smolen J, Kay J, Daoyle MK, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet 2009; 374: 210-221. .
Chatzidionysiou K, Lie E, Nasonov E, et al. Highest clinical effectiveness of rituximab in autoantibody-positive patients with rheumatoid arthritis and in those for whom no more than one previous TNF antagonist has failed: pooled data from 10 European registries. Ann Rheum Dis 2011; 70: 1575-1580. .
Soliman MM, Hyrich KL, Lunt M, et al. Rituximab or a second anti-tumor necrosis factor therapy for rheumatoid arthritis patients who have failed their first anti-tumor necrosis factor therapy? Comparative analysis from the British Society for Rheumatology Biologics Register. Arthritis Care Res (Hoboken) 2012; 64: 1108-1115. .
Soliman MM, Hyrich KL, Lunt M, et al. Effectiveness of rituximab in patients with rheumatoid arthritis: observational study from the British Society for Rheumatology Biologics Register. J Rheumatol 2012; 39: 240-246. .
Finckh A, Ciurea A, Brulhart L, et al. B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents. Arthritis Rheum 2007; 56: 1417-1423. .
Strangfeld A, Eveslage M, Listing J, et al. Effectiveness of treatment with rituximab depends on autoantibody status – results from 2 years of experience in the German biologics register RABBIT [abstract]. Arthritis Rheum 2009; 60 Suppl 10: 1695. .
van Vollenhoven RF, Chatzidionysiou K, Nasonov E, et al. Six-Month Results From the Collaborative European REgistries for Rituximab in Rheumatoid Arthritis (CERERRA). Efficacy of Rituximab Is Highest in RF-Positive Patients and in Those Who Failed at Most One Prior Anti-TNF [abstract]. Arthritis Rheum 2009; 60 Suppl 10: 1671. .
Bijlsma JW. Optimal treatment of rheumatoid arthritis: EULAR recommendations for clinical practice. Pol Arch Med Wewn 2010; 120: 347-353. .
Tłustochowicz W, Filipowicz-Sosnowska A, Kucharz EJ, et al. Treatment of patient with rheumatoid arthritis in daily practice of rheumatologist – results of the nationwide survey [in Polish]. Reumatologia 2008; 46: 330-339. .
Kulig M, Malec Z, Tłustochowicz W. Analysis of ambulatory treatment with methotrexate in patients treated for rheumatoid arthritis [in Polish]. Reumatologia 2009; 47: 202-206. .
Sokka T, Kautiainen H, Toloza S, et al. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries. Ann Rheum Dis 2007; 66; 1491-1496.
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