Rooks Daniel, Praestgaard Jens, Hariry Sam, Laurent Didier, Petricoul Olivier, Perry Robert G, Lach-Trifilieff Estelle, Roubenoff Ronenn
Novartis Institutes for Biomedical Research, Cambridge, Massachusetts.
Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
J Am Geriatr Soc. 2017 Sep;65(9):1988-1995. doi: 10.1111/jgs.14927. Epub 2017 Jun 27.
To assess the effects of bimagrumab on skeletal muscle mass and function in older adults with sarcopenia and mobility limitations.
A 24-week, randomized, double-blind, placebo-controlled, parallel-arm, proof-of-concept study.
Five centers in the United States.
Community-dwelling adults (N = 40) aged 65 and older with gait speed between 0.4 and 1.0 m/s over 4 m and an appendicular skeletal muscle index of 7.25 kg/m or less for men and 5.67 kg/m or less for women.
Intravenous bimagrumab 30 mg/kg (n = 19) or placebo (n = 21).
Change from baseline in thigh muscle volume (TMV), subcutaneous and intermuscular fat, appendicular and total lean body mass, grip strength, gait speed, and 6-minute walk distance (6MWD).
Thirty-two (80%) participants completed the study. TMV increased by Week 2, was sustained throughout the treatment period, and remained above baseline at the end of study in bimagrumab-treated participants, whereas there was no change with placebo treatment (Week 2: 5.15 ± 2.19% vs -0.34 ± 2.59%, P < .001; Week 4: 6.12 ± 2.56% vs 0.16 ± 3.42%, P < .001; Week 8: 8.01 ± 3.70% vs 0.35 ± 3.32%, P < .001; Week 16: 7.72 ± 5.31% vs 0.42 ± 5.14%, P < .001; Week 24: 4.80 ± 5.81% vs -1.01 ± 4.43%, P = .002). Participants with slower walking speed at baseline receiving bimagrumab had clinically meaningful and statistically significantly greater improvements in gait speed (mean 0.15 m/s, P = .009) and 6MWD (mean 82 m, P = .022) than those receiving placebo at Week 16. Adverse events in the bimagrumab group included muscle-related symptoms, acne, and diarrhea, most of which were mild in severity and resolved by the end of study.
Treatment with bimagrumab over 16 weeks increased muscle mass and strength in older adults with sarcopenia and improved mobility in those with slow walking speed.
评估比马鲁单抗对患有肌肉减少症和行动受限的老年人骨骼肌质量和功能的影响。
一项为期24周的随机、双盲、安慰剂对照、平行组概念验证研究。
美国的五个中心。
年龄在65岁及以上的社区居住成年人（N = 40），4米步行速度在0.4至1.0米/秒之间，男性四肢骨骼肌指数为7.25千克/平方米或更低，女性为5.67千克/平方米或更低。
静脉注射30毫克/千克比马鲁单抗（n = 19）或安慰剂（n = 21）。
大腿肌肉体积（TMV）、皮下和肌间脂肪、四肢和总体瘦体重、握力、步行速度和6分钟步行距离（6MWD）相对于基线的变化。
32名（80%）参与者完成了研究。在接受比马鲁单抗治疗的参与者中，TMV在第2周增加，在整个治疗期间持续增加，在研究结束时仍高于基线，而安慰剂治疗则无变化（第2周：5.15±2.19% 对 -0.34±2.59%，P <.001；第4周：6.12±2.56% 对 0.16±3.42%，P <.001；第8周：8.01±3.70% 对 0.35±3.32%，P <.001；第16周：7.72±5.31% 对 0.42±5.14%，P <.001；第24周：4.80±5.81% 对 -1.01±4.43%，P =.002）。在第16周时，基线步行速度较慢且接受比马鲁单抗治疗的参与者在步行速度（平均0.15米/秒，P =.009）和6MWD（平均82米，P =.022）方面的改善在临床上具有意义且在统计学上显著优于接受安慰剂治疗的参与者。比马鲁单抗组的不良事件包括肌肉相关症状、痤疮和腹泻，大多数严重程度为轻度，在研究结束时缓解。
16周的比马鲁单抗治疗增加了患有肌肉减少症的老年人的肌肉质量和力量，并改善了步行速度慢的老年人的行动能力。
