Altoona Center for Clinical Research, Duncansville, PA 16635, USA.
Pain. 2013 Jul;154(7):1009-21. doi: 10.1016/j.pain.2013.03.006. Epub 2013 Mar 14.
Tanezumab is a humanized monoclonal antibody that specifically inhibits nerve growth factor as a treatment for chronic pain. This phase IIB study investigated the efficacy and safety of tanezumab for chronic low back pain vs placebo and naproxen. Patients (N=1347) received intravenous tanezumab (5, 10, or 20mg every 8weeks), naproxen (500mg twice daily), or placebo. The primary efficacy end point was mean change in daily average low back pain intensity (LBPI) from baseline to week 16. Secondary end points included mean change from baseline to week 16 in the Roland Morris Disability Questionnaire and Patient's Global Assessment (PGA) of low back pain. Tanezumab 10 and 20mg had similar efficacy profiles and significantly improved LBPI, Roland Morris Disability Questionnaire, and PGA scores vs both placebo and naproxen (P⩽.05). Tanezumab 5mg provided improvement of PGA scores vs placebo (P⩽.05), and naproxen resulted in significant improvement of LBPI vs placebo (P⩽.05). Adverse event incidence was comparable across tanezumab doses but higher than with placebo or naproxen. Arthralgia, pain in extremity, headache, and paresthesia were the most commonly reported adverse events by tanezumab-treated patients. The most frequently reported adverse events resulting in discontinuation of tanezumab treatment were arthralgia and paresthesia; the highest frequency was observed with tanezumab 20mg (both 1.4%). Serious adverse event incidence was similar across treatments. In conclusion, tanezumab provided significantly greater improvement in pain, function, and global scores vs placebo and naproxen in patients with chronic low back pain.
地舒单抗是一种人源化单克隆抗体，特异性抑制神经生长因子，用于治疗慢性疼痛。这项 IIB 期研究调查了地舒单抗治疗慢性腰痛与安慰剂和萘普生的疗效和安全性。患者（N=1347）接受静脉内地舒单抗（5、10 或 20mg，每 8 周一次）、萘普生（500mg，每日两次）或安慰剂治疗。主要疗效终点是从基线到第 16 周时每日平均腰痛强度（LBPI）的平均变化。次要终点包括从基线到第 16 周时 Roland Morris 残疾问卷和患者对腰痛的总体评估（PGA）的平均变化。地舒单抗 10 和 20mg 具有相似的疗效特征，与安慰剂和萘普生相比，LBPI、Roland Morris 残疾问卷和 PGA 评分均显著改善（P ⩽.05）。地舒单抗 5mg 与安慰剂相比，PGA 评分有所改善（P ⩽.05），而萘普生与安慰剂相比，LBPI 显著改善（P ⩽.05）。地舒单抗各剂量组的不良事件发生率相当，但高于安慰剂或萘普生组。关节痛、四肢疼痛、头痛和感觉异常是接受地舒单抗治疗的患者最常报告的不良事件。导致地舒单抗治疗停止的最常报告的不良事件是关节痛和感觉异常；地舒单抗 20mg 组（均为 1.4%）发生率最高。各治疗组严重不良事件发生率相似。总之，地舒单抗治疗慢性腰痛患者的疼痛、功能和总体评分显著优于安慰剂和萘普生。
