Etanercept in severe active rheumatoid arthritis: first Australian experience.
BACKGROUND: Etanercept reduces disease activity in adults with chronic rheumatoid arthritis (RA) who are resistant to other therapies. Medicare Australia Pharmaceutical Benefit Scheme subsidized treatment (since August 2003) restricts etanercept availability to a most drug-resistant RA population. The aim of the study was to assess the efficacy of etanercept in this unique group after 12 months of therapy. METHODS: A prospective study of the first 50 consecutive private practice, adult RA patients whom were commenced on etanercept. The primary efficacy measures included short form 36 scores, Disease Activity Score 28, American College of Rheumatology (ACR) response improvement in per cent and the ACR individual core set components at baseline, 3 and 12 months. Analysis was by intention to treat. RESULTS: There was significant improvement in all mean short form 36 component scores (P < 0.05) and all ACR core set component scores (P < 0.05) comparing 12 months to baseline. The disease activity score 28 also significantly fell from baseline at both 3 and 12 months (P < 0.05). The ACR 20% response significantly improved (P < 0.05) both at baseline to 3 months 92% (81.2, 96.9) and to 12 months 80% (67.0, 88.8). Serious adverse events occurred in 16%. At 12 months 88% completed treatment. CONCLUSION: Etanercept therapy will, by 3 and 12 months, significantly improve the short form 36, disease activity score 28, ACR 20% response and core set components. Our results are similar to international studies using etanercept in efficacy and tolerance despite our cohort being more resistant to preceding drug therapy. Etanercept offers this unique active severe refractory late RA Australian population a new therapeutic option to control their disease.