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.