ObjectiveTo report 52‐week safety and efficacy of ianalumab from phase 2b dose‐finding study in patients with Sjögren's disease (SjD).MethodsPatients randomly received (1:1:1:1) ianalumab (5, 50, or 300 mg) or placebo subcutaneously every 4 weeks till week 24 (treatment period [TP]1). At week 24, patients on 300 mg were re‐randomized to continue 300 mg or receive placebo till week 52 (TP2), patients on placebo were switched to ianalumab 150 mg, while patients on 5 and 50 mg directly entered post treatment safety follow‐up. Patients who discontinued treatment early or completed treatment entered safety follow‐up (≥20 weeks).ResultsDuring TP1, 190 patients were randomized (placebo=49, 5 mg=47, 50 mg=47, 300 mg=47). Of these 190 patients, 90 (47.4 %; 43 continued 300 mg and 47 received placebo) entered TP2, and 81/90 (90.0%) completed the study treatment. By week 52, efficacy was sustained in patients who continued 300 mg in TP2 (ESSDAI, ESSPRI, PaGA, PhGA change from week 24: −1.45, −0.46, −4.69, −6.86, respectively). Stimulated salivary flow rates and autoantibody levels numerically improved in the 300 mg group. Treatment‐emergent adverse events were not dose‐dependent, except for injection‐site reactions. Cases of decreased neutrophil counts (CTCAE v4.03 grade 3 according to laboratory listings) were observed in 3 patients during the post‐treatment follow‐up, occurring at 3.5, 5.5, and 3 months, after the last ianalumab administration. None were associated with infection except one incidental finding of asymptomatic cytomegalovirus infection (IgM+).ConclusionIn patients with SjD, ianalumab 300 mg demonstrated sustained efficacy through week 52 and a favorable safety profile up to two years of follow‐up.

中文翻译：

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Ianalumab 在干燥症患者中的安全性和有效性：一项随机、安慰剂对照、2b 期剂量范围研究的 52 周结果


目的报告干燥病 （SjD） 患者 2b 期剂量探索研究中 ianalumab 的 52 周安全性和有效性。方法患者每 4 周随机接受 （1：1：1：1） ianalumab （5、50 或 300 mg） 或安慰剂皮下注射，直至第 24 周 （治疗期 [TP]1）。在第 24 周，服用 300 mg 的患者被重新随机分配继续服用 300 mg 或接受安慰剂至第 52 周 （TP2），服用安慰剂的患者改用 150 mg 伊那利尤单抗，而服用 5 和 50 mg 的患者直接进入治疗后安全随访。提前停止治疗或完成治疗的患者进入安全随访 （≥20 周）。结果TP1期间，随机分配190例患者（安慰剂=49,5 mg=47,50 mg=47,300 mg=47）。在这 190 名患者中，90 名 （47.4 %;43 名继续服用 300 毫克，47 名接受安慰剂）进入 TP2,81/90 （90.0%） 完成研究治疗。到第 52 周，继续 300 mg TP2 的患者疗效得以维持 （ESSDAI 、 ESSPRI 、 PaGA 、 PhGA 与第 24 周相比的变化分别为：-1.45、 -0.46、 -4.69、 -6.86）。300 mg 组刺激的唾液流速和自身抗体水平在数值上得到改善。治疗中出现的不良事件不是剂量依赖性的，除了注射部位反应。在治疗后随访期间，在 3 例患者中观察到中性粒细胞计数降低的病例 （根据实验室列表，CTCAE v4.03 3 级），发生在最后一次 ianalumab 给药后 3.5 、 5.5 和 3 个月。除了一次偶然发现的无症状巨细胞病毒感染 （IgM+） 外，没有一项与感染相关。结论在 SjD 患者中，ianalumab 300 mg 在第 52 周表现出持续疗效，并且在长达两年的随访中具有良好的安全性。