Real-world outcomes after anifrolumab initiation in systemic lupus erythematosus: a pragmatic treat-to-target analysis.

IF 2.7 3区医学 Q2 RHEUMATOLOGY

Clinical Rheumatology Pub Date : 2026-10-05 DOI:10.1007/s10067-026-08455-7

Dalifer Freites Núñez, Paloma Camarero Diaz, Sara Rodríguez Montes, Cristina Martínez Prada, Cristina Lajas Petisco, Lydia Abasolo, Benjamin Fernández Gutierrez

{"title":"Real-world outcomes after anifrolumab initiation in systemic lupus erythematosus: a pragmatic treat-to-target analysis.","authors":"Dalifer Freites Núñez, Paloma Camarero Diaz, Sara Rodríguez Montes, Cristina Martínez Prada, Cristina Lajas Petisco, Lydia Abasolo, Benjamin Fernández Gutierrez","doi":"10.1007/s10067-026-08455-7","DOIUrl":null,"url":null,"abstract":"Introduction/objectives: Treat-to-target (T2T) strategies in systemic lupus erythematosus (SLE) emphasise remission or low disease activity together with glucocorticoid minimisation. Real-world evidence evaluating anifrolumab using predefined target-oriented outcomes remains limited. We evaluated outcomes after anifrolumab initiation within a pragmatic T2T framework.Methods: This retrospective single-centre cohort included adults with SLE receiving anifrolumab. The study-defined pragmatic low disease activity composite required SLEDAI-2K ≤ 4, Physician Global Assessment ≤ 1, prednisone ≤ 7.5 mg/day, and absence of clinically significant renal activity. Prednisone ≤ 5 mg/day was explored in sensitivity analyses. Outcomes were assessed at baseline and 1, 3, 6, and 12 months. Longitudinal changes in SLEDAI-2K, PGA, and prednisone dose were analysed using linear mixed-effects models.Results: Nineteen patients were included (median baseline SLEDAI-2K 12.0 and median PGA 2.0). Composite attainment using prednisone ≤ 7.5 mg/day was 5.3% at 1 month, 47.4% at 3 months, 50.0% at 6 months, and 8/12 (66.7%) at 12 months. Using prednisone ≤ 5 mg/day, attainment was 36.8% at 3 months, 50.0% at 6 months, and 66.7% at 12 months. Disease activity components were met earlier than glucocorticoid thresholds. Mixed-effects models showed significant reductions in SLEDAI-2K, PGA, and prednisone dose during follow-up. One patient permanently discontinued anifrolumab due to influenza A, and one temporarily interrupted treatment because of pneumonia.Conclusions: After anifrolumab initiation, the proportion of evaluable patients meeting the pragmatic composite increased alongside reductions in disease activity and glucocorticoid dose. These exploratory findings suggest a potential role for anifrolumab within T2T strategies and warrant confirmation in larger controlled studies using validated treatment targets.","PeriodicalId":10482,"journal":{"name":"Clinical Rheumatology","volume":" ","pages":""},"PeriodicalIF":2.7000,"publicationDate":"2026-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Rheumatology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10067-026-08455-7","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Introduction/objectives: Treat-to-target (T2T) strategies in systemic lupus erythematosus (SLE) emphasise remission or low disease activity together with glucocorticoid minimisation. Real-world evidence evaluating anifrolumab using predefined target-oriented outcomes remains limited. We evaluated outcomes after anifrolumab initiation within a pragmatic T2T framework.

Methods: This retrospective single-centre cohort included adults with SLE receiving anifrolumab. The study-defined pragmatic low disease activity composite required SLEDAI-2K ≤ 4, Physician Global Assessment ≤ 1, prednisone ≤ 7.5 mg/day, and absence of clinically significant renal activity. Prednisone ≤ 5 mg/day was explored in sensitivity analyses. Outcomes were assessed at baseline and 1, 3, 6, and 12 months. Longitudinal changes in SLEDAI-2K, PGA, and prednisone dose were analysed using linear mixed-effects models.

Results: Nineteen patients were included (median baseline SLEDAI-2K 12.0 and median PGA 2.0). Composite attainment using prednisone ≤ 7.5 mg/day was 5.3% at 1 month, 47.4% at 3 months, 50.0% at 6 months, and 8/12 (66.7%) at 12 months. Using prednisone ≤ 5 mg/day, attainment was 36.8% at 3 months, 50.0% at 6 months, and 66.7% at 12 months. Disease activity components were met earlier than glucocorticoid thresholds. Mixed-effects models showed significant reductions in SLEDAI-2K, PGA, and prednisone dose during follow-up. One patient permanently discontinued anifrolumab due to influenza A, and one temporarily interrupted treatment because of pneumonia.

Conclusions: After anifrolumab initiation, the proportion of evaluable patients meeting the pragmatic composite increased alongside reductions in disease activity and glucocorticoid dose. These exploratory findings suggest a potential role for anifrolumab within T2T strategies and warrant confirmation in larger controlled studies using validated treatment targets.

查看原文本刊更多论文

在系统性红斑狼疮的无瘤单抗启动后的现实世界结果：一个实用的治疗目标分析。

介绍/目的：系统性红斑狼疮（SLE）的从治疗到目标（T2T）策略强调缓解或降低疾病活动性以及糖皮质激素最小化。使用预定义的目标导向结果评估anifrolumab的真实证据仍然有限。我们在实用的T2T框架内评估了anfrolumab起始后的结果。方法：这项回顾性单中心队列研究纳入了接受anfrolumab治疗的成年SLE患者。研究定义的实用低疾病活动性组合要求SLEDAI-2K≤4，医师总体评估≤1，强的松≤7.5 mg/天，无临床显著的肾脏活动。以强的松≤5mg /天为敏感性分析对象。在基线和1、3、6和12个月时评估结果。采用线性混合效应模型分析SLEDAI-2K、PGA和强的松剂量的纵向变化。结果：纳入19例患者（基线SLEDAI-2K中位数为12.0，PGA中位数为2.0）。强的松≤7.5 mg/天的综合疗效在1个月时为5.3%，3个月时为47.4%，6个月时为50.0%，12个月时为8/12（66.7%）。使用强的松≤5 mg/天，3个月时达到36.8%，6个月时达到50.0%，12个月时达到66.7%。疾病活动性成分比糖皮质激素阈值更早达到。混合效应模型显示SLEDAI-2K、PGA和强的松剂量在随访期间显著降低。一名患者因甲型流感而永久停用anfrolumab，一名患者因肺炎而暂时中断治疗。结论：在anfrolumab开始治疗后，随着疾病活动性和糖皮质激素剂量的降低，符合实用组合的可评估患者的比例增加。这些探索性发现提示anfrolumab在T2T治疗策略中的潜在作用，并需要在使用有效治疗靶点的大型对照研究中得到证实。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Clinical Rheumatology 医学-风湿病学

CiteScore

6.90

自引率

2.90%

发文量

441

审稿时长

3 months

期刊介绍： Clinical Rheumatology is an international English-language journal devoted to publishing original clinical investigation and research in the general field of rheumatology with accent on clinical aspects at postgraduate level. The journal succeeds Acta Rheumatologica Belgica, originally founded in 1945 as the official journal of the Belgian Rheumatology Society. Clinical Rheumatology aims to cover all modern trends in clinical and experimental research as well as the management and evaluation of diagnostic and treatment procedures connected with the inflammatory, immunologic, metabolic, genetic and degenerative soft and hard connective tissue diseases.