So Alexander, De Meulemeester Marc, Pikhlak Andrey, Yücel A Eftal, Richard Dominik, Murphy Valda, Arulmani Udayasankar, Sallstig Peter, Schlesinger Naomi
University Hospital of Lausanne, Lausanne, Switzerland.
Arthritis Rheum. 2010 Oct;62(10):3064-76. doi: 10.1002/art.27600.
To assess the efficacy and tolerability of canakinumab, a fully human anti-interleukin-1β monoclonal antibody, for the treatment of acute gouty arthritis.
In this 8-week, single-blind, double-dummy, dose-ranging study, patients with acute gouty arthritis whose disease was refractory to or who had contraindications to nonsteroidal antiinflammatory drugs and/or colchicine were randomized to receive a single subcutaneous dose of canakinumab (10, 25, 50, 90, or 150 mg; n = 143) or an intramuscular dose of triamcinolone acetonide (40 mg; n = 57). Patients assessed pain using a 100-mm visual analog scale.
Seventy-two hours after treatment, a statistically significant dose response was observed for canakinumab. All canakinumab doses were associated with numerically less pain than triamcinolone acetonide; thus, a dose with equivalent efficacy to triamcinolone acetonide 72 hours after treatment could not be determined. The reduction from baseline in pain intensity with canakinumab 150 mg was greater than with triamcinolone acetonide 24, 48, and 72 hours after treatment (differences of -11.5 mm [P = 0.04], -18.2 mm [P = 0.002], and -19.2 mm [P < 0.001], respectively), and 4, 5, and 7 days after treatment (all P < 0.05). Canakinumab significantly reduced the risk of recurrent flares versus triamcinolone acetonide (P ≤ 0.01 for all doses) (relative risk reduction 94% for canakinumab 150 mg versus triamcinolone acetonide). The overall incidence of adverse events was similar for canakinumab (41%) and triamcinolone acetonide (42%); most were mild or moderate in severity.
Our findings indicate that canakinumab 150 mg provides rapid and sustained pain relief in patients with acute gouty arthritis, and significantly reduces the risk of recurrent flares compared with triamcinolone acetonide.
评估全人源抗白细胞介素-1β单克隆抗体卡那单抗治疗急性痛风性关节炎的疗效和耐受性。
在这项为期8周的单盲、双模拟、剂量范围研究中，将对非甾体抗炎药和/或秋水仙碱治疗无效或有禁忌证的急性痛风性关节炎患者随机分为接受单次皮下注射卡那单抗（10、25、50、90或150mg；n = 143）或肌肉注射曲安奈德（40mg；n = 57）。患者使用100mm视觉模拟量表评估疼痛程度。
治疗72小时后，观察到卡那单抗有统计学意义的剂量反应。所有卡那单抗剂量在数值上的疼痛程度均低于曲安奈德；因此，无法确定治疗72小时后与曲安奈德疗效相当的剂量。治疗后24、48和72小时以及治疗后4、5和7天，150mg卡那单抗使疼痛强度较基线的降低幅度大于曲安奈德（差异分别为-11.5mm[P = 0.04]、-18.2mm[P = 0.002]和-19.2mm[P < 0.001]）（所有P < 0.05）。与曲安奈德相比，卡那单抗显著降低了复发发作的风险（所有剂量P≤0.01）（150mg卡那单抗与曲安奈德相比相对风险降低94%）。卡那单抗（41%）和曲安奈德（42%）的不良事件总发生率相似；大多数不良事件为轻度或中度。
我们的研究结果表明，150mg卡那单抗可使急性痛风性关节炎患者迅速且持续地缓解疼痛，与曲安奈德相比，显著降低了复发发作的风险。
