Objective Upon commencement of therapy for active disease, patients with systemic lupus erythematosus (SLE) show varying evolution regarding disease activity measures and patient-reported outcomes (PROs). Our objective was to identify disease evolution trajectories to gain a deeper understanding of SLE progression, ultimately improving future trial design. Methods Patients with ≥2 visits and available data on SLEDAI-2K, BILAG, PGA, FACIT-F, and glucocorticoid use were included in a post-hoc analysis of four randomised controlled trials of belimumab (BLISS-52, BLISS-76, BLISS-SC, EMBRACE). Growth mixture modelling identified latent classes. Results Among 2868 patients analysed, baseline median disease duration was 4.5 (IQR: 1.5–9.7) years and mean (± standard deviation) SDI 0.7 (±2.0), SLEDAI-2K 10.2 (±3.6), BILAG 17.0 (±7.8), PGA 1.5 (±0.5), FACIT-F 30.6 (±11.9), and prednisone dose 11.0 (±8.9) mg/day. In the initial model, glucocorticoid use and dose yielded high standard errors, indicating a weak link with the latent process. A refined model considered only clinical measures and FACIT-F, corrected for intervention and SDI; no other covariates improved the fit. Four classes best described disease evolution: highly active, responders; highly active, non-responders; moderately active, responders; moderately active, non-responders. LLDAS and DORIS remission attainment associated with latent classes. Conclusion By linking disease activity measures with PROs, we identified four distinct trajectories describing SLE evolution following the initiation of therapy. This classification could be valuable for personalising treatment and guiding biological studies aimed at distinguishing patients with varying anticipated treatment responses, as no single clinical variable alone can predict disease progression.

中文翻译：

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系统性红斑狼疮治疗开始后疾病演变轨迹：贝利尤单抗四项临床试验的结果


目的 在活动性疾病开始治疗后，系统性红斑狼疮 （SLE） 患者在疾病活动指标和患者报告结果 （PRO） 方面表现出不同的演变。我们的目标是确定疾病演变轨迹，以更深入地了解 SLE 进展，最终改进未来的试验设计。方法 将 ≥2 次就诊的患者以及 SLEDAI-2K、BILAG、PGA、FACIT-F 和糖皮质激素使用的可用数据纳入贝利尤单抗的四项随机对照试验 （BLISS-52、BLISS-76、BLISS-SC、EMBRACE） 的事后分析。生长混合模型确定了潜在类别。结果 在分析的 2868 例患者中，基线中位病程为 4.5 （IQR： 1.5-9.7） 年，平均 （± 标准差） SDI 0.7 （±2.0）、SLEDAI-2K 10.2 （±3.6）、BILAG 17.0 （±7.8）、PGA 1.5 （±0.5）、FACIT-F 30.6 （±11.9） 和泼尼松剂量 11.0 （±8.9） mg/天。在初始模型中，糖皮质激素的使用和剂量产生高标准误差，表明与潜伏过程的联系较弱。改进模型仅考虑临床测量和 FACIT-F，并针对干预和 SDI 进行了校正;没有其他协变量提高了拟合度。最能描述疾病演变的四类：高度活跃、反应者;高度活跃、无反应者;中等活跃，反应者;中等活跃度，无反应者。与潜在类别相关的 LLDAS 和 DORIS 缓解实现情况。结论通过将疾病活动指标与 PRO 联系起来，我们确定了描述治疗开始后 SLE 演变的四种不同轨迹。 这种分类对于个性化治疗和指导旨在区分具有不同预期治疗反应的患者的生物学研究可能很有价值，因为没有单一的临床变量可以单独预测疾病进展。