Lynen Nils A, Eichhorn Christoph, Portelange Nicolas, Chausson Mickaël, Weyenberg Wim
Praxiszentrum Elisengalerie, Aachen, Germany.
KiOmed Pharma, 4 rue Haute Claire, 4040, Herstal, Belgium.
Rheumatol Ther. 2024 Jun;11(3):649-662. doi: 10.1007/s40744-024-00661-6. Epub 2024 Mar 18.
Evaluate the real-world efficacy of a single intra-articular injection of carboxymethyl-chitosan (CM-chitosan), a new product class for knee osteoarthritis (OA).
This post-marketing study included adult patients with knee OA, who received a single injection of 60 mg CM-chitosan (currently marketed as KioMedineone) according to the instructions for use. Follow-up was performed at weeks 1, 12, 24, and 36. Efficacy was evaluated using a Visual Analog Scale (VAS) score for pain, the Knee injury and Osteoarthritis Outcome Score (KOOS), Patient's Global Assessment (PGA), and overall patient satisfaction.
Forty-nine patients were included in the study. VAS pain score significantly decreased from a median of 49.0 mm at baseline to 24.0 mm at week 1 and to 18 mm at week 36. Pain improvement was stable since at week 36; 91.8% of patients confirmed pain reduction. All KOOS subscales (symptoms, pain, activities of daily living, sports and recreational activities, quality of life) improved significantly compared to baseline at all time points. KOOS pain improved progressively from a median of 58.3% at baseline (mean 56.2 ± 18.8%) to 86.1% (mean 74.1 ± 24%) at week 36 compared to baseline. Overall, more than 70% of patients reported a condition gain (PGA), matching well with the more than 75% of patients being satisfied with the treatment. At 6 months, 72.7% of the patients could be classified as responder according to the OMERACT-OARSI proposed set of responder criteria.
CM-chitosan showed a rapid onset of pain relief after 1 week and with a duration of 9 months. In a real-world setting, treatment with CM-chitosan would appear to be a potentially effective option to reduce pain and improve physical function and global condition in patients with knee OA, opening new perspectives in patients who are considered as refractory to current symptomatic therapies and where the unmet need is high.
NCT04757051 (ClinicalTrials.gov).
评估单次关节腔内注射羧甲基壳聚糖（CM-壳聚糖）这一用于膝关节骨关节炎（OA）的新型产品在现实世界中的疗效。
这项上市后研究纳入了成年膝关节OA患者，他们按照使用说明接受了一次60毫克CM-壳聚糖（目前商品名为KioMedineone）的注射。在第1、12、24和36周进行随访。使用视觉模拟量表（VAS）疼痛评分、膝关节损伤和骨关节炎疗效评分（KOOS）、患者整体评估（PGA）以及患者总体满意度来评估疗效。
49名患者纳入研究。VAS疼痛评分从基线时的中位数49.0毫米显著降至第1周时的24.0毫米以及第36周时的18毫米。自第36周起疼痛改善情况稳定；91.8%的患者确认疼痛减轻。与基线相比，所有KOOS子量表（症状、疼痛、日常生活活动、运动和娱乐活动、生活质量）在所有时间点均有显著改善。KOOS疼痛评分从基线时的中位数58.3%（平均56.2±18.8%）逐渐改善至第36周时的86.1%（平均74.1±24%）。总体而言，超过70%的患者报告病情改善（PGA），与超过75%的患者对治疗满意情况相符。在6个月时，根据OMERACT - OARSI提出的应答者标准，72.7% 的患者可被归类为应答者。
CM - 壳聚糖在1周后显示出快速的疼痛缓解起效，且持续时间长达9个月。在现实世界中，CM - 壳聚糖治疗似乎是减轻膝关节OA患者疼痛、改善身体功能和整体状况的一种潜在有效选择，为那些被认为对当前对症治疗难治且未满足需求较高的患者开辟了新的前景。
NCT04757051（ClinicalTrials.gov）
