Department of Biomedical and Neuromotor Sciences, University of Bologna, 40126 Bologna, Italy.
Unit of Bologna, CNR-Institute of Molecular Genetics "Luigi Cavalli Sforza", 40136 Bologna, Italy.
Int J Mol Sci. 2023 Aug 5;24(15):12474. doi: 10.3390/ijms241512474.
Pathogenetic mechanism recognition and proof-of-concept clinical trials were performed in our patients affected by collagen VI-related myopathies. This study, which included 69 patients, aimed to identify innovative clinical data to better design future trials. Among the patients, 33 had Bethlem myopathy (BM), 24 had Ullrich congenital muscular dystrophy (UCMD), 7 had an intermediate phenotype (INTM), and five had myosclerosis myopathy (MM). We obtained data on muscle strength, the degree of contracture, immunofluorescence, and genetics. In our BM group, only one third had a knee extension strength greater than 50% of the predicted value, while only one in ten showed similar retention of elbow flexion. These findings should be considered when recruiting BM patients for future trials. All the MM patients had axial and limb contractures that limited both the flexion and extension ranges of motion, and a limitation in mouth opening. The immunofluorescence analysis of collagen VI in 55 biopsies from 37 patients confirmed the correlation between collagen VI defects and the severity of the clinical phenotype. However, biopsies from the same patient or from patients with the same mutation taken at different times showed a progressive increase in protein expression with age. The new finding of the time-dependent modulation of collagen VI expression should be considered in genetic correction trials.
我们对患有胶原 VI 相关肌病的患者进行了致病机制识别和概念验证临床试验。这项研究纳入了 69 名患者,旨在确定创新的临床数据,以更好地设计未来的试验。患者中,33 名患有 Bethlem 肌病(BM),24 名患有 Ullrich 先天性肌营养不良症(UCMD),7 名患有中间表型(INTM),5 名患有肌硬化性肌病(MM)。我们获取了肌肉力量、挛缩程度、免疫荧光和遗传学方面的数据。在我们的 BM 组中,只有三分之一的患者膝关节伸展力量大于预测值的 50%,而只有十分之一的患者保留了类似的肘部弯曲力量。在未来的试验中招募 BM 患者时应考虑这些发现。所有 MM 患者都有轴向和肢体挛缩,限制了关节的屈伸运动范围,以及张口受限。对 37 名患者的 55 份活检标本进行的胶原 VI 免疫荧光分析证实了胶原 VI 缺陷与临床表型严重程度之间的相关性。然而,来自同一患者或同一突变患者在不同时间采集的活检标本显示,蛋白表达随年龄呈进行性增加。在基因矫正试验中应考虑到胶原 VI 表达的时间依赖性调节这一新发现。