Efficacy and Safety of Etanercept in Severely Active Rheumatoid Arthritis: 6-month, Open Label, Prospective, Observational Study from Iraq

Abstract

Objective: To assess the efficacy and safety of etanercept in severely active rheumatoid arthritis (RA) in a sample of Iraqi patients.

Patients and methods: An open labeled single group prospective observational study was conducted over 15 months on 190 Iraqi patients with RA diagnosed according to 1987 American College of Rheumatology criteria. All the included patients were given etanercept at a dose of 50 mg by subcutaneous injection on weekly bases. Disease activity score at 28 joints (DAS28) and functional class of RA were measured at baseline and after 6months.

Results: There was significant improvement in disease activity (DAS28) (p<0.001) with percent of change (-29.26%) and functional disability (P=0.001) with etanercept use over a period of 6 months. Elevated liver transaminase were 3.68%, leucopenia 3.15%, headache 2.11%, itching 2.11%,  serious chest infection 1.57%, leg abscess 0.52%,  injection site reactions 1.05%, breast cancer  0.52, and  drug induced psoriasis 0.52%.

Conclusion: Etanercept was effective and relatively safe in treatment of RA patients among Iraqi patients.

Keywords: Etanercept, Rheumatoid arthritis, Diseases activity score 28 (DAS28).