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.
Keywords: TNF inhibitors; rheumatoid arthritis; treatment failure; treatment modification.