Ruxolitinib用于covid -19相关细胞因子风暴的紧急治疗：来自扩大准入研究的发现

IF 2.2 4区医学 Q3 RESPIRATORY SYSTEM Clinical Respiratory Journal Pub Date : 2025-04-08 DOI:10.1111/crj.70050

Jeffrey Weinstein, Nikhil Jagan, Shawnta Lorthridge-Jackson, J. E. Hamer-Maansson, Peg Squier

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引用次数: 0

摘要

该扩大准入计划（EAP）为符合住院条件的患者提供ruxolitinib（口服，选择性Janus激酶[JAK]1/JAK2抑制剂）用于covid -19相关细胞因子风暴的紧急治疗（NCT04355793）。方法患者服用ruxolitinib 5 mg，每日2次（耐受时首选方案）或每日1次，疗程≤14天，或直至无临床获益。结果包括临床状态、医生评估的临床获益和严重不良事件（SAE）发生率。结果312例患者中，45.5%的患者临床状态改善≥1点。42.6%的可评估患者报告了经医生评估的临床获益。42.9%发生SAE，其中2.6%发生疑似与鲁索利替尼相关的SAE。结论总体而言，部分新冠肺炎相关细胞因子风暴住院患者接受鲁索利替尼治疗后，临床状况有所改善；Ruxolitinib耐受性良好。试验注册ClinicalTrials.gov标识符：NCT04355793

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Ruxolitinib for Emergency Treatment of COVID-19–Associated Cytokine Storm: Findings From an Expanded Access Study

Introduction

This expanded access program (EAP) provided ruxolitinib (oral, selective Janus kinase [JAK]1/JAK2 inhibitor) for emergency treatment of COVID-19–associated cytokine storm in patients eligible for hospitalization (NCT04355793).

Methods

Patients received ruxolitinib 5 mg twice daily (preferred regimen when tolerated) or once daily for ≤ 14 days, or until determination of no clinical benefit was made. Outcomes were clinical status, physician-assessed clinical benefit, and serious adverse event (SAE) incidence.

Results

Of 312 patients, 45.5% achieved ≥ 1-point clinical status improvement. Physician-assessed clinical benefit was reported in 42.6% of evaluable patients. SAEs occurred in 42.9%, with 2.6% experiencing an SAE suspected to be ruxolitinib related.

Conclusions

Overall, some hospitalized patients with COVID-19–associated cytokine storm who received ruxolitinib experienced clinical status improvement; ruxolitinib was well tolerated.

Trial Registration

ClinicalTrials.gov identifier: NCT04355793

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来源期刊

Clinical Respiratory Journal 医学-呼吸系统

CiteScore

3.70

自引率

0.00%

发文量

104

审稿时长

>12 weeks

期刊介绍： Overview Effective with the 2016 volume, this journal will be published in an online-only format. Aims and Scope The Clinical Respiratory Journal (CRJ) provides a forum for clinical research in all areas of respiratory medicine from clinical lung disease to basic research relevant to the clinic. We publish original research, review articles, case studies, editorials and book reviews in all areas of clinical lung disease including: Asthma Allergy COPD Non-invasive ventilation Sleep related breathing disorders Interstitial lung diseases Lung cancer Clinical genetics Rhinitis Airway and lung infection Epidemiology Pediatrics CRJ provides a fast-track service for selected Phase II and Phase III trial studies. Keywords Clinical Respiratory Journal, respiratory, pulmonary, medicine, clinical, lung disease, Abstracting and Indexing Information Academic Search (EBSCO Publishing) Academic Search Alumni Edition (EBSCO Publishing) Embase (Elsevier) Health & Medical Collection (ProQuest) Health Research Premium Collection (ProQuest) HEED: Health Economic Evaluations Database (Wiley-Blackwell) Hospital Premium Collection (ProQuest) Journal Citation Reports/Science Edition (Clarivate Analytics) MEDLINE/PubMed (NLM) ProQuest Central (ProQuest) Science Citation Index Expanded (Clarivate Analytics) SCOPUS (Elsevier)