Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus
Anifrolumab reduces flare rates in patients with moderate to severe systemic lupus erythematosus
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DOI：
10.1177/09612033211014267
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发表时间：
2021-05-12
期刊：
影响因子：
2.6
通讯作者：
Tummala, Raj
中科院分区：
文献类型：
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作者：
Furie, Richard;Morand, Eric F.;Tummala, Raj
背景系统性红斑狼疮（SLE）的治疗目标包括预防疾病发作，同时尽量减少糖皮质激素的暴露.汇总数据从3期TULIP-1和TULIP-2试验中的中度至重度SLE患者进行了分析，以确定阿尼福禄单抗的效果耀斑，包括那些出现与糖皮质激素taper.MethodsTULIP-1和TULIP-2随机，安慰剂对照，52周的试验静脉注射阿尼福禄单抗（300毫克，每4周48周）。对于接受基线糖皮质激素≥ 10 mg/天的患者，尝试与上次访视相比逐渐减少至≥ 1个新BILAG-2004 A或≥ 2个新BILAG-2004 B评分。结果与安慰剂组（n = 366）相比，阿尼福鲁单抗组（n = 360）与较低的年发作率相关（率比0.75，95%置信区间[CI] 0.60-0.95），至首次发作的时间延长（风险比0.70，95%CI 0.55-0.89），且发作≥ 1次的患者较少（差异-9.3%，95%CI-16.3至-2.3），基线时通常活跃的器官领域（肌肉骨骼、粘膜皮肤）的发作也较少。与安慰剂组（30.4%，34/112）相比，阿尼福鲁单抗组（21.1%，36/171）中基于BILAG的狼疮综合评估应答者出现≥ 1次发作的人数较少。在基线时糖皮质激素从>= 10 mg/天持续减少的患者中，与安慰剂（17.3%，32/185）相比，更多的患者保持了阿尼福鲁单抗（40.0%，76/190）的无发作。结论对汇总的TULIP-1和TULIP-2数据的分析支持阿尼福鲁单抗减少了发作，同时允许糖皮质激素逐渐减少患者中的糖皮质激素，这些患者具有SLE.ClinicalTrials.gov标识符TULIP-1 NCT 02446912（clinicaltrials.gov/ct2/show/NCT02446912）;TULIP-2 NCT 02446899（clinicaltrials.gov/ct2/show/NCT02446899）。
BackgroundSystemic lupus erythematosus (SLE) management objectives include preventing disease flares while minimizing glucocorticoid exposure. Pooled data from the phase 3 TULIP-1 and TULIP-2 trials in patients with moderate to severe SLE were analyzed to determine anifrolumab's effect on flares, including those arising with glucocorticoid taper.MethodsTULIP-1 and TULIP-2 were randomized, placebo-controlled, 52-week trials of intravenous anifrolumab (300 mg every 4 weeks for 48 weeks). For patients receiving baseline glucocorticoid >= 10 mg/day, attempted taper to = 1 new BILAG-2004 A or >= 2 new BILAG-2004 B scores versus the previous visit. Flare assessments were compared for patients receiving anifrolumab versus placebo.ResultsCompared with placebo (n = 366), anifrolumab (n = 360) was associated with lower annualized flare rates (rate ratio 0.75, 95% confidence interval [CI] 0.60-0.95), prolonged time to first flare (hazard ratio 0.70, 95% CI 0.55-0.89), and fewer patients with >= 1 flare (difference -9.3%, 95% CI -16.3 to -2.3), as well as flares in organ domains commonly active at baseline (musculoskeletal, mucocutaneous). Fewer BILAG-based Composite Lupus Assessment responders had >= 1 flare with anifrolumab (21.1%, 36/171) versus placebo (30.4%, 34/112). Of patients who achieved sustained glucocorticoid reductions from >= 10 mg/day at baseline, more remained flare free with anifrolumab (40.0%, 76/190) versus placebo (17.3%, 32/185).ConclusionsAnalyses of pooled TULIP-1 and TULIP-2 data support that anifrolumab reduces flares while permitting glucocorticoid taper in patients with SLE.ClinicalTrials.gov identifiersTULIP-1 NCT02446912 (clinicaltrials.gov/ct2/show/NCT02446912);TULIP-2 NCT02446899 (clinicaltrials.gov/ct2/show/NCT02446899).