Etanercept, tumor necrosis factor (TNF-alpha) antagonist, lowers the disease activity level in patients with rheumatoid arthritis (RA), reduces joint destruction saving physical functions and improving life quality.
The aim of this study was to establish efficacy and safety of etanercept in combination with disease modifying antirheumatic drugs (DMARDs) in the treatment of RA.
To patients with active RA, who were on therapy with DMARD, etanercept was introduced in weekly doses of 50 mg, with continuation of DMARD. Efficacy of this form of treatment was evaluated in the 12th week. Maintenance of the effect of treatment was also evaluated during 24, 48 and 96 weeks. Long-term evaluation of etanercept safety was assessed by registering all unwanted events during a two-year period.
After 12 weeks of treatment with etanercept, 80% of patients had ACR20 response, while 85% showed clinically significant decrease of DAS28 index. We achieved remission in five patients (12.5%) and low activity of RA in 17 patients (42.5%). During a 96-week of follow-up period, achieved therapy effects were maintained. In four patients (10%) etanercept therapy was interrupted after 24 weeks because of inadequate response. In one of them (2.5%) we recorded a cardiovascular incident. Acute infections were registered in 47 cases. Four of those were severe infections. Neither cases of malignancy development were noted, nor were there any lethal disease outcomes.
Etanercept in combination with DMARD shows a high level of efficacy in the treatment of RA. The safety profile of the drug is satisfactory.