Publication details

Anti-TNF therapy of ankylosing spondylitis in clinical practice. Results from the Czech national registry ATTRA



Year of publication 2009
Type Conference abstract
MU Faculty or unit

Description Background: Registries of biologicals provide, in addition to data obtained from RCTs, important information about long-term efficacy/safety and adherence to therapy in daily clinical practice. The Czech National registry ATTRA for AS was founded in 2003. Objectives: To evaluate long term efficacy/safety using validated outcome measures. To estimate survival on therapy for the 3 individual anti TNF drugs. To evaluate working disability of patients with AS treated by anti TNF drugs. Methods: The indication criteria for anti TNF therapy included: BASDAI > 4, failure to respond to conventional therapy, expert opinion and CRP > 10 mg/l. The monitored treatment efficacy endpoints were: BASDAI, BASFI, HAQ, EuroQol, CRP, global estimation of effect by patient and physician. Adherence to therapy was evaluated using Kaplan - Maier analysis. Cox regression was used for evaluation of risk factors of treatment discontinuation. Results: We present results from the total of 310 patients who have completed at least one year of treatment or who have discontinued therapy by this date. Drug survival rates of AS patients were very good and significantly better than in patients with rheumatoid arthritis patients in the ATTRA registry (N=1033) (88% vs. 81% after 1 year, 80% vs. 60% after 2 years, and 76% vs. 51% after 3 years, p = 0.001). Female gender and higher CRP values were risk factors for the discontinuation of treatment; however, no association was found with disease duration, BASDAI and presence of hip involvement. The comparison among various anti-TNF agents has not shown statistically significant difference. The efficacy of anti- TNF treatment was good, with a decrease of BASDAI scores from mean baseline values of 6.4+-1.7 to 3.6+-2.6 after 3 months and to 3.1+-2.6 after 1 year; the efficacy has been maintained for the next 2 years. Initial mean CRP values of 31.0+-26.5 mg/l had decreased significantly as early as after 3 months of treatment (5.2+-10.2 mg/l). This effect then persisted for up to 3 years of follow-up. The proportion of patients who were working has increased from 48% at baseline to 63% after one year of therapy. In the course of 3 years, 80 out of 310 patients discontinued the therapy. Adverse events or lack of efficacy were the most frequent causes of discontinuation. Conclusion: Treatment with anti TNF agents in daily clinical practice is very effective and well tolerated, with very good adherence to therapy. The study was supported by grant of University of Health Nr. MZO 00023728 Disclosure of Interest: Dr. Pavelka was consultant to Abbott Laboratories, Wyeth Whitehall, Schering Plough, ROCHE and Bristol Myers Squibb

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