Department of Anesthesiology and Critical Care, Johns Hopkins School of Medicine , Baltimore, MD, USA.
Expert Rev Clin Pharmacol. 2020 Jun;13(6):631-639. doi: 10.1080/17512433.2020.1772052. Epub 2020 Jun 4.
The treatment of chronic low back pain (cLBP) often involves multimodal pharmacologic and non-pharmacologic strategies. There remain shortcomings with these tools with regards to both effect size and side effects.
In an effort to better address cLBP, anti-nerve growth factor (NGF) monoclonal antibodies (mAbs) are nearing marketing approval. This class of medications has been primarily evaluated for osteoarthritis, but are being examined at higher doses for use in cLBP. We review the efficacy of this class in treating LBP as well as their potential side effects based on nine phase II or III published clinical trials. Five trials evaluated Tanezumab and four trials evaluated Fasinumab, with seven trials evaluating nonspecific LBP, one evaluating sciatica related cLBP, and one evaluating vertebral fracture related cLBP.
The results of available clinical trials indicate modest effectiveness with regard to reduction of pain in the low back, and improved functionality, compared to placebo in keeping with the effect size of other pharmacologic treatment modalities. Rapidly progressive osteoarthritis was infrequently reported. However, the continued observation of this serious side effects warrants careful patient selection and balancing the risks and benefits of anti-NGF mAbs in treating cLBP.
慢性下腰痛(cLBP)的治疗通常涉及多模式的药物和非药物策略。这些工具在疗效和副作用方面都存在不足。
为了更好地治疗 cLBP,抗神经生长因子(NGF)单克隆抗体(mAbs)已接近上市批准。这类药物主要在骨关节炎中进行了评估,但在更高剂量下也在用于治疗 cLBP。我们根据九项已发表的 II 期或 III 期临床试验,评估了这类药物治疗 LBP 的疗效及其潜在的副作用。五项试验评估了 Tanezumab,四项试验评估了 Fasinumab,其中七项试验评估了非特异性 LBP,一项评估了与坐骨神经痛相关的 cLBP,一项评估了与椎体骨折相关的 cLBP。
现有临床试验结果表明,与安慰剂相比,在减轻腰痛和改善功能方面,这类药物具有适度的疗效,与其他药物治疗方式的疗效大小一致。快速进展性骨关节炎的报告罕见。然而,这种严重副作用的持续观察需要仔细选择患者,并权衡抗 NGF mAbs 治疗 cLBP 的风险和收益。