Understanding the correlation between transplant symptoms, health-related quality of life (HRQoL), and graft outcomes is needed to support patient-focused drug development and posttransplant management. A post-hoc analysis of patient-reported outcomes from the Phase III belatacept trials was conducted in order to investigate the interrelationship between trajectories of HRQoL, symptom experience, and allograft outcomes. HRQoL and symptom experience were evaluated using Short-Form 36 Survey (SF-36) and Modified Transplant Symptom Occurrence and Distress Scale (MTSOSD-59R), respectively. HRQoL was captured in 831 eligible renal transplant patients at baseline, 12, 24, and 36 months posttransplant. Following transplantation, patients reported improvements in all SF-36 subscales compared to baseline. Latent class analysis revealed four trajectories in perceived general health, which were associated with graft failure after adjustment. Compared to patients with good perceived health, patients with fair and poor perceived health had 4.7 (95% confidence interval [CI] 1.5-14.8, P < .01) and 19.8 (95% CI 5.9-66.0, P < .01) times the risk of graft failure, respectively. Using multinomial logistic regression, different sets of symptoms were associated with perceived general health at baseline and 12 months posttransplant. The study supports monitoring HRQoL and symptom experience to capture each patient's health perspective, improve drug development, and optimize posttransplant management.

中文翻译：

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与移植物失败和症状困扰相关的肾移植患者的健康相关生活质量轨迹：BENEFIT 和 BENEFIT-EXT 试验分析。

需要了解移植症状、健康相关生活质量 (HRQoL) 和移植结果之间的相关性，以支持以患者为中心的药物开发和移植后管理。对来自 III 期 belatacept 试验的患者报告结果进行了事后分析，以调查 HRQoL 轨迹、症状体验和同种异体移植结果之间的相互关系。HRQoL 和症状体验分别使用简表 36 调查 (SF-36) 和改良的移植症状发生和痛苦量表 (MTSOSD-59R) 进行评估。在基线、移植后 12、24 和 36 个月时，在 831 名符合条件的肾移植患者中捕获了 HRQoL。移植后，患者报告与基线相比所有 SF-36 子量表都有改善。潜在类别分析揭示了感知总体健康状况的四个轨迹，这些轨迹与调整后的移植失败有关。与自觉健康良好的患者相比，自觉健康一般和差的患者有 4.7（95% 置信区间 [CI] 1.5-14.8，P < .01）和 19.8（95% CI 5.9-66.0，P < .01）次移植失败的风险，分别。使用多项逻辑回归，不同的症状集与基线和移植后 12 个月的总体健康状况相关。该研究支持监测 HRQoL 和症状体验，以捕捉每位患者的健康观点、改进药物开发并优化移植后管理。自觉健康一般和较差的患者移植失败的风险分别为 4.7（95% 置信区间 [CI] 1.5-14.8，P < .01）和 19.8（95% CI 5.9-66.0，P < .01）。使用多项逻辑回归，不同的症状集与基线和移植后 12 个月的总体健康状况相关。该研究支持监测 HRQoL 和症状体验，以捕捉每位患者的健康观点、改进药物开发并优化移植后管理。自觉健康一般和较差的患者移植失败的风险分别为 4.7（95% 置信区间 [CI] 1.5-14.8，P < .01）和 19.8（95% CI 5.9-66.0，P < .01）。使用多项逻辑回归，不同的症状集与基线和移植后 12 个月的总体健康状况相关。该研究支持监测 HRQoL 和症状体验，以捕捉每位患者的健康观点、改进药物开发并优化移植后管理。