Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study.

Methods

Adults with SLE received subcutaneous anifrolumab 120 mg or placebo once weekly for 52 weeks (1:1 randomization).

患有SLE的成人每周一次皮下注射120 mg的anifrolumab或安慰剂，持续52周（1:1随机分配）。

Only the primary endpoint (treatment difference in BILAG-based Composite Lupus Assessment [BICLA] response at 52 weeks) was formally tested in a preplanned interim analysis; key secondary and other endpoints were tested in the full analysis.

只有主要终点（基于BILAG的综合红斑狼疮评估[BICLA]在52周的治疗差异）在预先计划的中期分析中进行了正式测试；关键的次要终点和其他终点在全面分析中进行了测试。

Results

At the interim analysis (220 patients, anifrolumab: n = 109; placebo: n = 111), the primary endpoint was met (anifrolumab vs placebo: 59.4% vs 43.9%; BICLA response difference 15.5%, 95% confidence interval[95% CI] 2.3-28.6; P = 0.0211).

在中期分析中（220名患者，anifrolumab：n=109；安慰剂：n=111），达到了主要终点（anifrolumab与安慰剂相比：59.4%对43.9%；BICLA反应差异15.5%，95%置信区间[95% CI] 2.3-28.6；P=0.0211）。

The full analysis included 367 patients (anifrolumab: n = 184; placebo: n = 183).

全分析包括了367名患者（anifrolumab组：n = 184；安慰剂组：n = 183）。

Versus placebo, more patients treated with anifrolumab attained a BICLA response while maintaining low/reduced oral glucocorticoid doses through week 52 (56.2% vs 34.0%; difference 22.3%, 95% CI 12.3-32.2; P < 0.0001), and the time to first sustained BICLA response was reduced (hazard ratio2.2, 95% CI 1.5-3.2; P < 0.0001).

与安慰剂相比，接受anifrolumab治疗的患者在第52周时维持低/减少口服糖皮质激素剂量的同时，达到BICLA应答的患者更多（56.2%对比34.0%；差异22.3%，95%置信区间12.3-32.2；P < 0.0001），并且首次持续BICLA应答的时间缩短（风险比2.2，95%置信区间1.5-3.2；P < 0.0001）。

Treatment differences in week 52 DORIS remission and Low Lupus Disease Activity State attainment rates favored anifrolumab over placebo (14.2%, 95% CI 5.6-22.8; P = 0.0012, and 14.1%, 95% CI 4.6-23.6; P = 0.0038).

在第52周，DORIS缓解率和低狼疮疾病活动状态的达成率方面，anifrolumab相对于安慰剂有优势（14.2%，95%置信区间5.6-22.8；P = 0.0012，以及14.1%，95%置信区间4.6-23.6；P = 0.0038）。

The frequencies of serious adverse events were 11.9% with anifrolumab and 10.4% with placebo; the frequencies of herpes zoster were 3.8% and 1.1%, respectively.

严重不良事件的发生频率为anifrolumab组的11.9%，安慰剂组的10.4%；带状疱疹的发生频率分别为3.8%和1.1%。

Conclusions

Consistent with the well-established profile of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant, clinically meaningful treatment benefits when added to standard therapy, and an acceptable safety profile in patients with moderate to severe SLE.

与静脉注射阿尼弗洛单抗的已知特性一致，皮下注射阿尼弗洛单抗在添加到标准治疗中时，对中度至重度系统性红斑狼疮（SLE）患者显示出显著的、临床意义上的治疗益处，并具有可接受的安全性特征。