WHO Collaborating Centre for Public Health Aspects of Musculo-Skeletal Health and Ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, 4000 Liège, Belgium.
Aptissen SA Medical Department, 1228 Plan-les-Ouates, Switzerland.
Biomolecules. 2021 Oct 11;11(10):1498. doi: 10.3390/biom11101498.
In a previous randomized trial, the non-inferiority of two hyaluronic acid injections (Synolis VA versus Synvisc-One) was assessed in patients with knee OA, with a response rate of 79% for Synolis VA. To assess whether a responder profile could be established for this treatment modality, we used the Synolis VA arm of a published 6-month prospective, multicenter, comparative, randomized, double-blinded trial. At baseline and during the study, pain and function were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire. Ninety-six subjects from the intention-to-treat trial were included in the analysis. The 6-month change of WOMAC Pain with Synolis VA was not associated with any baseline clinical data. However, the change in WOMAC Function was significantly associated with its baseline level, even after adjustment for potential confounding variables ( = 0.028), i.e., a poorer physical function at baseline was associated with a better response. In conclusion, in addition to the high absolute response rate to Synolis VA, the probability of success is even increased if administered in patients with more limited physical function at baseline. Further research with other potential confounding clinical variables is warranted in order to better applicate the concept of personalized medicine.
在之前的一项随机试验中,评估了两种透明质酸注射剂(Synolis VA 与 Synvisc-One)在膝骨关节炎患者中的非劣效性,Synolis VA 的应答率为 79%。为了评估这种治疗方式是否可以建立应答者特征,我们使用了已发表的为期 6 个月的前瞻性、多中心、比较、随机、双盲试验的 Synolis VA 臂进行评估。在基线和研究期间,使用 Western Ontario 和 McMaster 大学关节炎指数(WOMAC)问卷评估疼痛和功能。共有 96 名意向治疗试验受试者纳入分析。Synolis VA 的 WOMAC 疼痛 6 个月的变化与任何基线临床数据均无关联。然而,WOMAC 功能的变化与基线水平显著相关,即使在调整了潜在混杂变量后(=0.028),即基线时身体功能较差与更好的应答相关。总之,除了 Synolis VA 的高绝对应答率外,如果在基线时身体功能更受限的患者中给予 Synolis VA,则成功的可能性甚至更高。为了更好地应用个体化医学的概念,需要进一步研究其他潜在的混杂临床变量。