Gomez Alvaro, Qiu Victor, Cederlund Arvid, Borg Alexander, Lindblom Julius, Emamikia Sharzad, Enman Yvonne, Lampa Jon, Parodis Ioannis
Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
Department of Gastroenterology, Dermatology and Rheumatology, Karolinska University Hospital, Stockholm, Sweden.
Front Med (Lausanne). 2021 Apr 16;8:651249. doi: 10.3389/fmed.2021.651249. eCollection 2021.
To determine the prevalence of adverse health-related quality of life (HRQoL) outcomes in patients with SLE who achieved an adequate clinical response after a 52-week long standard therapy plus belimumab or placebo, and identify contributing factors. We included patients who met the primary endpoint of the BLISS-52 (NCT00424476) and BLISS-76 (NCT00410384) trials, i.e., SLE Responder Index 4 (total population: = 760/1,684; placebo: = 217/562; belimumab 1 mg/kg: = 258/559; belimumab 10 mg/kg: = 285/563). Adverse HRQoL outcomes were defined as SF-36 scale scores ≤ the 5th percentile derived from age- and sex-matched population-based norms, and FACIT-Fatigue scores <30. We investigated factors associated with adverse HRQoL outcomes using logistic regression analysis. We found clinically important diminutions of HRQoL in SLE patients compared with matched norms and high frequencies of adverse HRQoL outcomes, the highest in SF-36 general health (29.1%), followed by FACIT-Fatigue (25.8%) and SF-36 physical functioning (25.4%). Overall, frequencies were higher with increasing age. Black/African American and White/Caucasian patients reported higher frequencies than Asians and Indigenous Americans, while Hispanics experienced adverse HRQoL outcome less frequently than non-Hispanics. Established organ damage was associated with adverse physical but not mental HRQoL outcomes; particularly, damage in the cardiovascular (OR: 2.12; 95% CI: 1.07-4.21; = 0.032) and musculoskeletal (OR: 1.41; 95% CI: 1.01-1.96; = 0.041) domains was associated with adverse SF-36 physical component summary. Disease activity showed no impact on HRQoL outcomes. In multivariable logistic regression analysis, addition of belimumab to standard therapy was associated with lower frequencies of adverse SF-36 physical functioning (OR: 0.59; 95% CI: 0.39-0.91; = 0.016) and FACIT-F (OR: 0.53; 95% CI: 0.34-0.81; = 0.004). Despite adequate clinical response to standard therapy plus belimumab or placebo, a substantial proportion of SLE patients still reported adverse HRQoL outcomes. While no impact was documented for disease activity, established organ damage contributed to adverse outcome within physical HRQoL aspects and add-on belimumab was shown to be protective against adverse physical functioning and severe fatigue.
为了确定在接受为期52周的标准疗法加贝利木单抗或安慰剂治疗后获得充分临床缓解的系统性红斑狼疮（SLE）患者中，与健康相关的生活质量（HRQoL）不良结局的患病率，并确定相关因素。我们纳入了符合BLISS - 52（NCT00424476）和BLISS - 76（NCT00410384）试验主要终点的患者，即SLE缓解指数4（总人群：n = 760/1684；安慰剂：n = 217/562；贝利木单抗1mg/kg：n = 258/559；贝利木单抗10mg/kg：n = 285/563）。HRQoL不良结局定义为SF - 36量表评分≤基于年龄和性别匹配的人群规范得出的第5百分位数，以及FACIT - 疲劳评分<30。我们使用逻辑回归分析研究与HRQoL不良结局相关的因素。我们发现，与匹配的规范相比，SLE患者的HRQoL有临床上重要的降低，且HRQoL不良结局的发生率较高，其中SF - 36总体健康方面最高（29.1%），其次是FACIT - 疲劳（25.8%）和SF - 36身体功能（25.4%）。总体而言，发生率随年龄增长而升高。黑人/非裔美国人和白人/高加索患者报告的发生率高于亚洲人和美洲原住民，而西班牙裔患者经历HRQoL不良结局的频率低于非西班牙裔患者。已有的器官损害与不良的身体HRQoL结局相关，但与精神方面无关；特别是，心血管（OR：2.12；95%CI：1.07 - 4.21；P = 0.032）和肌肉骨骼（OR：1.41；95%CI：1.01 - 1.96；P = 0.041）领域的损害与不良的SF - 36身体成分总结相关。疾病活动对HRQoL结局无影响。在多变量逻辑回归分析中，在标准疗法中添加贝利木单抗与较低的SF - 36身体功能不良发生率（OR：0.59；95%CI：0.39 - 0.91；P = 0.016）和FACIT - F（OR：0.53；95%CI：0.34 - 0.81；P = 0.004）相关。尽管对标准疗法加贝利木单抗或安慰剂有充分的临床反应，但仍有相当比例的SLE患者报告了HRQoL不良结局。虽然未记录到疾病活动的影响，但已有的器官损害导致了身体HRQoL方面的不良结局，并且添加贝利木单抗被证明可预防不良的身体功能和严重疲劳。
