PDF(Pubmed)
Abstract：
OBJECTIVE: There are few effective osteoarthritis (OA) therapies. A novel injectable polyacrylamide hydrogel (iPAAG) previously demonstrated efficacy and safety up to week 26 in an open-label study of knee OA. Here we report longer-term effectiveness and safety data.
METHODS: This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).
RESULTS: 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.
CONCLUSIONS: This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.
BACKGROUND: Clinicaltrials.gov NCT04179552.
METHODS: This multi-centre, open-label study included patients with symptomatic and radiographic knee OA. Primary outcome was WOMAC pain (0-100 scale) at 13 weeks, and patients continued to 26 weeks before entering a further 26-week extension phase. Secondary efficacy outcomes included WOMAC stiffness and function subscales, Patient Global Assessment (PGA) and proportion of OMERACT-OARSI responders. Safety outcomes were adverse events (AEs).
RESULTS: 49 participants (31 women, mean age 70) received an ultrasound-guided, intra-articular injection of 6 ml iPAAG; 46 completed the extension phase to 52 weeks. There was a significant reduction in the WOMAC pain score from baseline to 52 weeks (- 17.7 points (95% CI - 23.1; - 12.4); p < 0.0001). Similar sustained improvements were observed for WOMAC stiffness (11.0 points; 95% CI - 17.0; - 4.9), physical function (18.0 points; 95% CI - 19.1; - 10.6), and PGA (16.3 points; 95% CI - 23.1; - 9.4). At 52 weeks 62.2% of patients were OMERACT-OARSI responders. From 26 to 52 weeks, 8 adverse effects (AE), including 1 serious AE (cerebrovascular accident) were reported in 5 subjects. None of the new adverse events were thought to be device related.
CONCLUSIONS: This open-label study suggests persistent benefits and safety of iPAAG through 52 weeks after a single injection.
BACKGROUND: Clinicaltrials.gov NCT04179552.
摘要：
目的：目前很少有有效的骨关节炎（OA）治疗方法。一种新型可注射聚丙烯酰胺水凝胶（iPAAG）先前在膝OA的开放标签研究中显示了长达26周的功效和安全性。在这里，我们报告了长期的有效性和安全性数据。
方法：这种多中心，开放标签研究包括有症状和影像学表现的膝关节OA患者.主要结果是13周时的WOMAC疼痛（0-100量表），患者持续到26周，然后进入另一个26周的延长期。次要疗效结果包括WOMAC硬度和功能分量表，患者全球评估(PGA)和OMERACT-OARSI应答者的比例。安全性结果为不良事件（AE）。
结果：49名参与者（31名女性，平均年龄70)接受超声引导，关节内注射6mliPAAG;46完成了延伸期至52周。WOMAC疼痛评分从基线到52周显著降低(-17.7分(95%CI-23.1;-12.4);p<0.0001)。WOMAC刚度观察到类似的持续改善(11.0分；95%CI-17.0；-4.9)，身体功能（18.0分；95%CI-19.1；-10.6），和PGA（16.3点；95%CI-23.1；-9.4）。在52周时，62.2％的患者为OMERACT-OARSI应答者。从26到52周，8不良反应（AE），包括1例严重的AE（脑血管意外）在5名受试者中报告。没有新的不良事件被认为与设备相关。
结论：这项开放标签研究表明，iPAAG在单次注射后52周内具有持续的益处和安全性。
背景：Clinicaltrials.govNCT04179552。
方法：这种多中心，开放标签研究包括有症状和影像学表现的膝关节OA患者.主要结果是13周时的WOMAC疼痛（0-100量表），患者持续到26周，然后进入另一个26周的延长期。次要疗效结果包括WOMAC硬度和功能分量表，患者全球评估(PGA)和OMERACT-OARSI应答者的比例。安全性结果为不良事件（AE）。
结果：49名参与者（31名女性，平均年龄70)接受超声引导，关节内注射6mliPAAG;46完成了延伸期至52周。WOMAC疼痛评分从基线到52周显著降低(-17.7分(95%CI-23.1;-12.4);p<0.0001)。WOMAC刚度观察到类似的持续改善(11.0分；95%CI-17.0；-4.9)，身体功能（18.0分；95%CI-19.1；-10.6），和PGA（16.3点；95%CI-23.1；-9.4）。在52周时，62.2％的患者为OMERACT-OARSI应答者。从26到52周，8不良反应（AE），包括1例严重的AE（脑血管意外）在5名受试者中报告。没有新的不良事件被认为与设备相关。
结论：这项开放标签研究表明，iPAAG在单次注射后52周内具有持续的益处和安全性。
背景：Clinicaltrials.govNCT04179552。
