Background The Czech national registry ATTRA collects data of patients treated by the biological drugs with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis. Abatacept has the position of the second line agent which can be prescribed after a failure of at least one TNFalfa inhibitor. ATTRA is prospective centralized computerized registry of patients and concentrates the data on efficacy, safety and on the quality of life. Data of patients treated by abatacept has been collected since 2008.
Objectives To perform the statistical anylysis of patients treated with abatacept
Methods ATTRA registers 162 patients, mean age of patients 51.0± 12.2 (median 53.1, 19-74 years). Mean duration of RA disease was 14±9.1, median 11.3 years (0-41). 130 were women (80.2%). DAS28- Disease Activity Score 28 was monitored as well as patients’ and physicians’ assessment of the efficacy of treatment. A remission was defined as DAS28<2.6. The quality of life was measured by the EuroQol and SF36 questionnaires, HAQ (Health Assessment Questionnaire) was used to determine functional impairment. Persistence of patients on treatment, reasons for premature discontinuation of treatment, biological treatment used before and after administration of abatacept were monitored as well. In order to observe the safety of treatment, the occurrence of serious and non-serious adverse effects was monitored. Results were processed by Statistica. StatSoft, Inc. (2011) STATISTICA (data analysis software system), version 10.
Results The mean DAS28 was at week 0 5.9±1.1, at week 16 4.1±1.4, at week 24 3.8±1.2, at week 36 3.6±1.3 and at week 52 3.5±1.2. DAS28 remission was achieved at week 16 in 15.8% (10.7%), at week 24 in 10% (20.8%), at week 36 20.9% and at week 52 20.8%. Patients with DAS28 <2.6 (remission) at week 16, had the DAS28 <2.6 in 58.3% also at the week 52. Patients with DAS28 >5.1 (high disease activity) at the week 16, had DAS >5.1 at the week 52 in 41.7%. One year on treatment survival was 82% Altogether 50 non-serious adverse events (AE) were reported in 36 patients (22%) and 11 serious AE in 10 patients (6%) with most common being infections (31) and skin rashes (5), just one non serious allergic reaction was reported.
Conclusions Presented data from the ATTRA registry represent four-year-long period of abatacept administration in the Czech Republic. Data from registry confirms a good overall efficacy and safety and a very good on drug survival of abatacept.
Acknowledgements: Funding: ATTRA registry, Czech Republic
Disclosure of Interest None Declared