Evaluation of the efficacy and safety of etanercept 50 mg once weekly in Japanese patients with rheumatoid arthritis and comparison with 25 mg etanercept twice weekly.

OBJECTIVE: Tumor necrosis factor-α inhibitors have been available in recent years for treating early and established rheumatoid arthritis (RA). Twice-weekly administration of 25 mg etanercept (ETN) has demonstrated efficacy and safety. The objective of this study was to evaluate the efficacy of once-weekly administration of 50 mg ETN (ETN50), and to compare it with that of twice-weekly administration of 25 mg ETN (ETN25).

METHODS: The ETN50 group comprised 29 patients and the ETN25 group 26. The analysis compared changes from baseline in Disease Activity Score in 28 joints (DAS28)-C reactive protein (CRP) and DAS28-erythrocyte sedimentation rate (ESR) between the ETN50 and ETN25 groups.

RESULTS: Overall, 42.3 % of ETN50 patients achieved DAS28-ESR remission (<2.6), and 76.9 % experienced low disease activity at 24 weeks. Patients in the ETN50 group also experienced more significant improvement in DAS28-ESR at 4 weeks, higher DAS28-ESR remission rates, and lower disease activity rates than ETN25 group patients. No serious adverse events were experienced in the safety analysis set (ETN50 group).

CONCLUSION: These results suggest that ETN50 can lead to earlier remission and higher remission rates compared with ETN25 in patients with RA.