Touma Zahi, Bruce Ian N, Furie Richard, Morand Eric, Tummala Raj, Chandran Shelly, Abreu Gabriel, Knagenhjelm Jacob, Arnold Kellyn, Lee Hopin, Ralphs Eleanor, Bedenkov Aleksandr, Kielar Danuta, Waratani Miina
Schroeder Arthritis Institute, Krembil Research Institute, University Health Network, Toronto, ON, Canada; University of Toronto Lupus Clinic, Centre for Prognosis Studies in Rheumatic Diseases, Toronto Western Hospital, Toronto, ON, Canada.
Centre for Musculoskeletal Research, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK; Centre for Public Health, Faculty of Medicine, Health and Life Sciences, Queens University Belfast, Belfast, UK.
Ann Rheum Dis. 2025 May;84(5):767-776. doi: 10.1016/j.ard.2025.01.025. Epub 2025 Feb 1.
Anifrolumab is approved for the treatment of systemic lupus erythematosus (SLE). We aimed to determine if anifrolumab plus standard of care (SOC) was associated with reduced organ damage accumulation in adult patients with moderately to severely active SLE compared to real-world (RW) external controls from the University of Toronto Lupus Clinic (UTLC) cohort who received SOC only.
Patients who initiated 300 mg anifrolumab in the TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway) trials were included in the anifrolumab arm; key eligibility criteria were applied to the UTLC to create the RW SOC arm. Propensity score and censoring weighting were used to account for baseline confounding and loss to follow-up. The primary endpoint was change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to week 208, and the secondary endpoint was time to first SDI score increase.
354 patients were included in the anifrolumab arm, and 561 patients were included in the RW SOC arm. Following weighting, mean change in SDI was 0.416 points lower (95% CI: -0.582, -0.249; P < .001) in the anifrolumab arm than in the RW SOC arm. Patients in the anifrolumab arm were 59.9% less likely (hazard ratio: 0.401; 95% CI: 0.213, 0.753, P = .005) to experience an increase in SDI within 208 weeks.
Patients who received anifrolumab accumulated significantly less organ damage after 208 weeks than patients who received RW SOC. The addition of anifrolumab to SOC is effective at preventing and/or delaying organ damage in patients with moderately to severely active SLE.
阿尼鲁单抗已被批准用于治疗系统性红斑狼疮（SLE）。我们旨在确定与仅接受标准治疗（SOC）的多伦多大学狼疮诊所（UTLC）队列的真实世界（RW）外部对照相比，阿尼鲁单抗加标准治疗（SOC）是否与中度至重度活动性SLE成年患者的器官损伤累积减少相关。
在TULIP（通过干扰素途径治疗难治性狼疮）试验中开始使用300mg阿尼鲁单抗的患者被纳入阿尼鲁单抗组；关键纳入标准应用于UTLC以创建RW SOC组。使用倾向评分和删失加权来解释基线混杂因素和失访情况。主要终点是从基线到第208周系统性红斑狼疮国际协作临床/美国风湿病学会损伤指数（SDI）评分的变化，次要终点是首次SDI评分增加的时间。
阿尼鲁单抗组纳入354例患者，RW SOC组纳入561例患者。加权后，阿尼鲁单抗组的SDI平均变化比RW SOC组低0.416分（95%CI：-0.582，-0.249；P<.001）。阿尼鲁单抗组患者在208周内SDI增加的可能性降低59.9%（风险比：0.401；95%CI：0.213，0.753，P=.005）。
接受阿尼鲁单抗治疗的患者在208周后累积的器官损伤明显少于接受RW SOC治疗的患者。在SOC基础上加用阿尼鲁单抗可有效预防和/或延迟中度至重度活动性SLE患者的器官损伤。
