Longer-term safety and efficacy of baricitinib for atopic dermatitis in pediatric patients 2 to <18 years old: a randomized clinical trial of extended treatment to 3.6 years.

Andreas Wollenberg, Masanori Ikeda, Chia-Yu Chu, Lawrence F Eichenfield, Marieke M B Seyger, Apurva Prakash, Robinette Angle, Danting Zhu, Marco Pontes, Amy S Paller
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Abstract

Background: Baricitinib, an oral selective Janus kinase inhibitor, improved clinical signs and symptoms of moderate-to-severe atopic dermatitis (AD) at week 16 in the phase 3 pediatric study BREEZE-AD-PEDS.

Objective: To assess longer-term efficacy and safety of baricitinib in pediatric patients aged 2 to <18 years.

Methods: In BREEZE-AD-PEDS long-term extension, responders and partial responders (validated Investigator Global Assessment-Atopic Dermatitis [vIGA-AD®] 0/1/2) at Week 16 remained on double-blind treatment to which they were randomized (placebo, baricitinib [1-mg equivalent, 2-mg equivalent, or 4-mg equivalent); non-responders (vIGA-AD 3 or 4) at Week 16 transitioned to open-label baricitinib 4-mg equivalent. Safety was summarized for all randomized patients who received ≥1 dose of study treatment.

Results: In total 467 patients received baricitinib for 750.7 patient-years. Proportion of responders/partial responders (at Week 16) who achieved vIGA-AD 0/1 at Week 52 was greater for baricitinib 4-mg equivalent (56.8%) versus all other treatment groups (42.2%, 47.7%, and 39.7% for 2-mg equivalent, 1-mg equivalent, and placebo, respectively). Most treatment-emergent adverse events were mild/moderate in severity. No deaths, pulmonary emboli, deep vein thromboses or arterial thrombotic events, major adverse cardiovascular events, malignancies, tuberculosis events, or gastrointestinal perforations were reported.

Conclusions: Baricitinib demonstrated sustained long-term efficacy. No new safety signals were identified.

Trial registration: ClinicalTrials.gov Identifier: NCT03952559.

巴利昔尼治疗2至18岁儿童特应性皮炎的长期安全性和有效性:延长治疗至3.6年的随机临床试验。
研究背景巴利昔尼是一种口服选择性Janus激酶抑制剂,在3期儿科研究BREEZE-AD-PEDS中,巴利昔尼在第16周改善了中重度特应性皮炎(AD)的临床症状和体征:目的:评估巴利昔尼在2至6岁儿童患者中的长期疗效和安全性:在BREEZE-AD-PEDS长期扩展研究中,第16周时应答者和部分应答者(有效的研究者全球评估-特异性皮炎[vIGA-AD®] 0/1/2)仍接受随机分配的双盲治疗(安慰剂、巴利替尼[1毫克当量、2毫克当量或4毫克当量]);第16周时无应答者(vIGA-AD 3或4)转为开放标签巴利替尼4毫克当量。对所有接受≥1个剂量研究治疗的随机患者的安全性进行了总结:共有467名患者接受了巴利替尼治疗,共750.7个患者年。巴利替尼4毫克等效剂量(56.8%)的应答者/部分应答者(第16周)在第52周达到vIGA-AD 0/1的比例高于所有其他治疗组(2毫克等效剂量、1毫克等效剂量和安慰剂分别为42.2%、47.7%和39.7%)。大多数治疗引发的不良反应为轻度/中度。未报告死亡、肺栓塞、深静脉血栓或动脉血栓事件、重大心血管不良事件、恶性肿瘤、结核事件或胃肠道穿孔:结论:巴瑞替尼具有持续的长期疗效。结论:巴瑞替尼具有持续的长期疗效,未发现新的安全信号:试验注册:ClinicalTrials.gov Identifier:NCT03952559。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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