Aim of the study: To investigate the effectiveness and safety of etanercept (ETA) treatment in patients with active rheumatoid arthritis (RA) and ankylosing spondylitis (AS) enrolled in the national therapeutic program.
Material and methods: The study was conducted in 55 adult patients with active RA (DAS28 > 5.8) and 33 adult patients with active AS (BASDAI > 7) who were enrolled in the ETA national therapeutic program as a first (40 RA patients) or second (15 RA patients) line biological therapy. The period of observation of RA patients lasted from 3 months to 9 years, whereas in AS patients it lasted from 1 to 30 months. The safety; rate of long-term remissions and primary or secondary ineffectiveness of ETA treatment were analyzed.
Results: Permanent remission (over 12 months without biological therapy) occurred in a similar percentage of RA patients (5–9%) and AS patients (3–9%). There were 7 non-responders (12.7%) to the initial treatment with ETA in a group of RA patients and 3 (9%) in AS patients (NS). Secondary ineffectiveness of ETA therapy was observed in 19 (34.5%) RA patients and in 2 (6.1%) AS patients. Side effects (infections and allergic skin reactions) were relatively rare, mainly at the beginning of therapy.
Conclusions: We conclude that ETA treatment is a safe and effective form of therapy in patients with active, long-term RA previously treated with various DMARDs, and in patients with active form of AS. Primary ineffectiveness of ETA therapy is relatively rare in RA and AS patients. On the other hand, the secondary ineffectiveness of therapy in RA patients is the reason for its discontinuation in about one-third of patients after ca. 28 months of treatment.