O'Dell James R, Petersen Kara, Leff Robert, Palmer William, Schned Eric, Blakely Kent, Haire Claire, Fernandez Ana
Department of Internal Medicine, University of Nebraska Medical Center, Omaha, 983025, USA.
J Rheumatol. 2006 Feb;33(2):213-8. Epub 2005 Dec 15.
To prospectively determine the efficacy and safety of etanercept in combination with sulfasalazine (SSZ), hydroxychloroquine (HCQ), and gold in the treatment of rheumatoid arthritis (RA).
A prospective open-label study enrolled 119 patients with RA who had active disease despite stable therapy with SSZ (n = 50), HCQ (n = 50), or intramuscular gold (n = 19). Primary efficacy endpoints consisted of American College of Rheumatology responses at 24 and 48 weeks. Safety was established at regularly scheduled visits.
Patients in each etanercept combination showed significant improvement at both 24 and 48 weeks. Toxicity withdrawals by 48 weeks included gold (n = 1): proteinuria; HCQ (n = 5): septic wrist and bilateral pneumonia, rash, optic neuritis, breast cancer, squamous cancer of the tongue; and SSZ (n = 5): otitis media, elevated liver function indicators, pericarditis, rash, and gastroenteritis. The most common adverse events not requiring discontinuation from the study were injection site reactions (43% of patients) and upper respiratory type infections (34%).
This study is the first to prospectively evaluate the safety of etanercept in combination with SSZ, HCQ, and gold in patients with RA. Etanercept in combination with SSZ, HCQ, or gold was efficacious and well tolerated, with a discontinuation rate of 9% (11/119) for adverse events at 48 weeks.
前瞻性地确定依那西普联合柳氮磺吡啶（SSZ）、羟氯喹（HCQ）和金制剂治疗类风湿关节炎（RA）的疗效和安全性。
一项前瞻性开放标签研究纳入了119例RA患者，这些患者尽管接受了SSZ（n = 50）、HCQ（n = 50）或肌肉注射金制剂（n = 19）的稳定治疗，但疾病仍处于活动期。主要疗效终点包括24周和48周时美国风湿病学会的反应。在定期随访时确定安全性。
每种依那西普联合治疗组的患者在24周和48周时均有显著改善。至48周因毒性而停药的情况包括：金制剂组（n = 1）：蛋白尿；HCQ组（n = 5）：腕关节感染、双侧肺炎、皮疹、视神经炎、乳腺癌、舌鳞状癌；SSZ组（n = 5）：中耳炎、肝功能指标升高、心包炎、皮疹和肠胃炎。最常见的无需停药的不良事件是注射部位反应（43%的患者）和上呼吸道感染（34%）。
本研究首次前瞻性评估了依那西普联合SSZ、HCQ和金制剂在RA患者中的安全性。依那西普联合SSZ、HCQ或金制剂有效且耐受性良好，48周时因不良事件的停药率为9%（11/119）。
