Background The efficacy of biological therapy has been proven in a number of randomized clinical trials. The important data are however provided by registries of the biological therapies that reflect the biological therapy in real clinical practice. Adherence to T2T principals in clinical practice was not established yet.
Objectives To evaluate predictive factors for achievement of remission or low disease activity of first anti TNF therapy.
Methods Efficacy of the first anti-TNF drug in rheumatoid arthritis (RA) treatment was evaluated during the first year of therapy. This evaluation included all patients receiving biological therapy in centres within the national registry of the biological therapy ATTRA in Czech Republic. This therapy was indicated in case of at least 1 DMARD failure and disease activity higher than DAS28 5.1.
Results There were 1945 patients enrolled in the study, 518 of which were treated with etanercept, 655 with infliximab, 747 with adalimumab, and 25 with golimumab. For analysis purposes, the monoclonal antibodies were amalgamated in one group consisting of 1427 patients. The average duration of the disease exceeded 10 years and the average number of DMARDs failed was 3. Disease activity at baseline was high; the mean DAS28 was 6.4 and mean CRP was about 29 mg/l. There were no significant differences between both groups by the initiation of therapy.
In both groups, DAS28 decreased significantly. Mean values in etanercept (ETA) were significantly lower in Week 10 than in monoclonal antibodies (p<0.001). Remission was achieved in 35% of patients treated with ETA and in 24.1% of patients treated with monoclonal antibodies in Week 54. Low disease activity was achieved in 51.6% of patients with ETA and in 40.5% of patients with monoclonal antibodies in Week 54. Significant factors to predict remission were the following: ETA therapy against monoclonal antibodies (HR 1.41 95% CI 1.167 – 1.708, p<0.001), age under 35 years (HR 2.086 95% CI 1.688 – 2.578, p<0.001), a duration of the disease less than 10 years (HR 1.438 95% CI 1.193 – 1.733, p<0.001), baseline DAS28 <4.5 and medical history with less than 3 DMARDs failed. No effect on the prediction of remission was found for neither gender, rheumatoid factors positivity and for concomitant treatment with methotrexate.
Conclusions Remission or LDA was achieved in about 50% of patients after 1 year of therapy. Predictive factors of the therapeutic response were the use of etanercept, lower age, short duration of the disease and lower baseline DAS28. Results reflect treatment before introduction of T2T principals. Its introduction should improve patients outcomes.
Supported by grant of Ministry of health Nr. MZO 00023728
Disclosure of Interest None Declared
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