Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial.
Secukinumab in enthesitis-related arthritis and juvenile psoriatic arthritis: a randomised, double-blind, placebo-controlled, treatment withdrawal, phase 3 trial.
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DOI：
10.1136/ard-2022-222849
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发表时间：
2023-01
影响因子：
27.4
通讯作者：
中科院分区：
文献类型：
--
作者：
附着点炎相关关节炎（ERA）和青少年银屑病关节炎（JPsA）患者的治疗选择目前有限。本试验旨在证明阿基诺单抗在对常规治疗反应不足的活动性ERA和JPsA患者中的疗效和安全性。在这项随机化、双盲、安慰剂对照、治疗退出、III期试验中，生物制剂初治患者活动性疾病患者（年龄2至<18岁）接受开放标签皮下注射阿基诺单抗治疗（75/150 mg，<50/≥50 kg的患者），治疗期（TP）1至第12周，和幼年特发性关节炎（JIA），在第12周时，将30名应答者以1：1随机分配至阿基诺单抗或安慰剂组，直至100周。在TP 2中发作的患者立即进入开放标签的阿基诺单抗TP 3，持续至第104周。主要终点是TP 2中至疾病发作的时间。共有86例患者（中位年龄14岁）进入TP 1的开放标签阿基诺单抗治疗。在TP 2中，应答者（ERA，44/52; JPsA，31/34）接受了阿基诺单抗或安慰剂。该研究达到了其主要终点，并证明了与安慰剂相比，在TP 2中ERA和JPsA的疾病发作时间在统计学上显著更长（27% vs 55%，HR，0.28; 95% CI 0.13至0.63; p<0.001）。在总体JIA人群中，总患者的暴露量校正发生率（每100患者-年（PY），95% CI）为290. 7/100 PY（230. 2 - 362. 3）不良事件和8. 2/100 PY（4. 1 - 14. 6）严重不良事件。在ERA和JPsA儿童中，苏金单抗的疾病发作时间显著长于安慰剂，与银屑病关节炎和中轴性脊柱关节炎的成人适应症一致的安全性特征。 NCT 03031782。
Treatment options in patients with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) are currently limited. This trial aimed to demonstrate the efficacy and safety of secukinumab in patients with active ERA and JPsA with inadequate response to conventional therapy. In this randomised, double-blind, placebo-controlled, treatment-withdrawal, phase 3 trial, biologic-naïve patients (aged 2 to <18 years) with active disease were treated with open-label subcutaneous secukinumab (75/150 mg in patients <50/≥50 kg) in treatment period (TP) 1 up to week 12, and juvenile idiopathic arthritis (JIA) American College of Rheumatology 30 responders at week 12 were randomised 1:1 to secukinumab or placebo up to 100 weeks. Patients who flared in TP2 immediately entered open-label secukinumab TP3 that lasted up to week 104. Primary endpoint was time to disease flare in TP2. A total of 86 patients (median age, 14 years) entered open-label secukinumab in TP1. In TP2, responders (ERA, 44/52; JPsA, 31/34) received secukinumab or placebo. The study met its primary end point and demonstrated a statistically significant longer time to disease flare in TP2 for ERA and JPsA with secukinumab versus placebo (27% vs 55%, HR, 0.28; 95% CI 0.13 to 0.63; p<0.001). Exposure-adjusted incidence rates (per 100 patient-years (PY), 95% CI) for total patients were 290.7/100 PY (230.2 to 362.3) for adverse events and 8.2/100 PY (4.1 to 14.6) for serious adverse events in the overall JIA population. Secukinumab demonstrated significantly longer time to disease flare than placebo in children with ERA and JPsA with a consistent safety profile with the adult indications of psoriatic arthritis and axial spondyloarthritis. NCT03031782.
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影响因子：
158.5
作者：
Baeten, Dominique;Sieper, Joachim;Richards, Hanno B.
通讯作者：
Richards, Hanno B.
DOI：
10.3899/jrheum.120642
发表时间：
2012-12
期刊：
The Journal of rheumatology
影响因子：
--
作者：
Weiss PF;Beukelman T;Schanberg LE;Kimura Y;Colbert RA;CARRA Registry Investigators
通讯作者：
CARRA Registry Investigators
影响因子：
6.7
作者：
Petitpain, Nadine;D'Amico, Ferdinando;Gillet, Pierre
通讯作者：
Gillet, Pierre
影响因子：
168.9
作者：
McInnes, Iain B.;Mease, Philip J.;Mpofu, Shephard
通讯作者：
Mpofu, Shephard
影响因子：
158.5
作者：
Langley, Richard G.;Elewski, Boni E.;Papavassilis, Charis
通讯作者：
Papavassilis, Charis