Chevalier X, Goupille P, Beaulieu A D, Burch F X, Bensen W G, Conrozier T, Loeuille D, Kivitz A J, Silver D, Appleton B E
Department of Rheumatology, Hospital Henri Mondor, University Paris XII, Créteil, France.
Arthritis Rheum. 2009 Mar 15;61(3):344-52. doi: 10.1002/art.24096.
To evaluate the clinical response, safety, and tolerability of a single intraarticular injection of anakinra in patients with symptomatic osteoarthritis (OA) of the knee.
Patients with OA of the knee were enrolled in a multicenter, double-blind, placebo-controlled study and randomized 2:1:2 to receive a single intraarticular injection of placebo, anakinra 50 mg, or anakinra 150 mg in their symptomatic knee. Patients were evaluated for 12 weeks postinjection. The primary end point was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from baseline to week 4. Safety assessments included the evaluation of adverse events (AEs), laboratory tests, and vital signs. Pharmacokinetic parameters were assessed in a subset of patients.
Of 170 patients who enrolled, 160 (94%) completed the study. The mean improvements from baseline to week 4 in the WOMAC score were not statistically different between the placebo group and the patients who received 50 mg of anakinra (P = 0.67) or 150 mg of anakinra (P = 0.77). Anakinra was well tolerated. No withdrawals due to AEs or serious AEs, and no serious infections or deaths were reported. No clinically significant trends were noted in laboratory values or vital signs. Pharmacokinetic parameters demonstrated that the mean terminal half-life of anakinra in serum after intraarticular injection was approximately 4 hours.
Anakinra was well tolerated as a single 50-mg or 150-mg intraarticular injection in patients with OA of the knee. However, anakinra was not associated with improvements in OA symptoms compared with placebo.
评估单剂量关节腔内注射阿那白滞素治疗症状性膝关节骨关节炎（OA）患者的临床反应、安全性及耐受性。
膝关节OA患者参与一项多中心、双盲、安慰剂对照研究，按2:1:2随机分组，在其症状性膝关节内单剂量关节腔内注射安慰剂、50mg阿那白滞素或150mg阿那白滞素。注射后对患者进行12周评估。主要终点是从基线到第4周时西安大略和麦克马斯特大学骨关节炎指数（WOMAC）评分的变化。安全性评估包括不良事件（AE）评估、实验室检查及生命体征检查。在部分患者中评估药代动力学参数。
170例入组患者中，160例（94%）完成研究。安慰剂组与接受50mg阿那白滞素（P = 0.67）或150mg阿那白滞素（P = 0.77）的患者相比，从基线到第4周时WOMAC评分的平均改善无统计学差异。阿那白滞素耐受性良好。未因AE或严重AE而停药，未报告严重感染或死亡。实验室检查值或生命体征未发现具有临床意义的趋势。药代动力学参数显示，关节腔内注射后阿那白滞素在血清中的平均终末半衰期约为4小时。
对于膝关节OA患者，单剂量50mg或150mg关节腔内注射阿那白滞素耐受性良好。然而，与安慰剂相比，阿那白滞素未改善OA症状。
