Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, Ontario, Canada
School of Public Health, Texas A&M University, College Station, Texas, USA.
Ann Rheum Dis. 2019 Mar;78(3):372-379. doi: 10.1136/annrheumdis-2018-214043. Epub 2019 Jan 4.
The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).
A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.
For the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (-0.434; 95% CI -0.667 to -0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.
PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.
本研究（206347）比较了接受贝利尤单抗治疗的系统性红斑狼疮（SLE）患者与多伦多狼疮队列（TLC）中接受标准治疗（SoC）的倾向评分（PS）匹配患者在 BLISS 长期扩展（LTE）研究中的器官损伤进展情况。
系统文献检索确定了 17 个已知的器官损伤预测因子，为每位患者计算 PS。BLISS LTE 和 TLC 的患者根据其 PS（±套管）进行了事后 1:1 的 PS 匹配。主要终点是从基线到 5 年时系统红斑狼疮国际合作临床/美国风湿病学会损伤指数（SDI）评分的变化差异。
在 5 年分析中，567 例患者（BLISS LTE 组 n=195；TLC 组 n=372）中，每队列有 99 例患者进行了 1:1 PS 匹配。与 SoC 相比，接受贝利尤单抗治疗的患者在第 5 年时 SDI 评分的变化明显更低（-0.434；95%CI-0.667 至-0.201；p<0.001）。对于器官损伤进展分析的时间（≥1 年随访），样本包括 965 例患者（BLISS LTE 组 n=259；TLC 组 n=706），其中每队列有 179 例患者进行了 PS 匹配。与接受 SoC 治疗的患者相比，接受贝利尤单抗治疗的患者在任何给定年份进展为更高 SDI 评分的可能性降低了 61%（HR 0.391；95%CI 0.253 至 0.605；p<0.001）。在 SDI 评分增加的患者中，SoC 组的增加≥2 的比例高于贝利尤单抗组。
与接受 SoC 治疗的患者相比，接受贝利尤单抗治疗的 PS 匹配患者的器官损伤进展明显较少。
