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<p>This multicenter, randomized, controlled study was conducted to explore the safety and efficacy of low-dose baricitinib plus danazol for ITP patients who had failed corticosteroids and at least one recommended subsequent treatment. Participants were randomly assigned to receive baricitinib plus danazol (<i>n</i> = 108) or danazol alone (n = 108) by a central, interactive web-based system. Patients and caregivers were not blinded to group assignment. Efficacy assessments were performed in the intention-to-treat population by investigators blinded to group assignment. The primary endpoint was 6-month durable response. Forty-nine (45.4%) patients in the combination arm and 22 (20.4%) patients in the monotherapy arm achieved 6-month durable response (<i>P</i> &lt; 0.001). The safety analysis set included patients who received at least one dose of study medication (n = 108 in the combination arm and n = 105 in the monotherapy arm). Fifty-two (48.1%) patients receiving baricitinib plus danazol and 47 (44.7%) patients receiving danazol alone reported at least one adverse event. Each arm reported two patients who developed an adverse event causing study discontinuation and one patient who developed a grade 3 or more severe adverse event. Low-dose baricitinib plus danazol might be a novel option for difficult-to-treat ITP. Funding: National Key Research and Development Program of China (No. 2023YFC2507800), National Natural Science Foundation of China (No. 82230004, No. 82430006, No. 82400157), Capital Health Development and Research of Special (No. 2022-1-4082), and Beijing Natural Science Foundation (No. 7242154 and No. 7232188). ClinicalTrials.gov identifier: NCT05852847.</p>

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Low-dose baricitinib plus danazol in primary immune thrombocytopenia: a randomized, controlled phase 2 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月25日

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  • Peng Zhao,
  • Zhuo-Yu An,
  • Hai-Xia Fu,
  • Yang Wang,
  • Guo-Shuang Feng,
  • Hui-Xin Liu,
  • Dai-Hong Liu,
  • Yi Liu,
  • He-Bing Zhou,
  • Hui Liu,
  • Zhao Wang,
  • Yu-Jun Dong,
  • Hong-Mei Jing,
  • Zhen-Ling Li,
  • Li-Hong Li,
  • Li-Ping Dou,
  • Qiu-Sha Huang,
  • Jin Wu,
  • Li-Ping Yang,
  • Yue Jin,
  • Zhi-Xue Li,
  • Chen-Cong Wang,
  • Qi Chen,
  • Xiao-Lu Zhu,
  • Yun He,
  • Yuan-Yuan Zhang,
  • Qian Jiang,
  • Hao Jiang,
  • Jin Lu,
  • Ying-Jun Chang,
  • Xiang-Yu Zhao,
  • Xiao-Jun Huang,
  • Xiao-Hui Zhang

摘要

This multicenter, randomized, controlled study was conducted to explore the safety and efficacy of low-dose baricitinib plus danazol for ITP patients who had failed corticosteroids and at least one recommended subsequent treatment. Participants were randomly assigned to receive baricitinib plus danazol (n = 108) or danazol alone (n = 108) by a central, interactive web-based system. Patients and caregivers were not blinded to group assignment. Efficacy assessments were performed in the intention-to-treat population by investigators blinded to group assignment. The primary endpoint was 6-month durable response. Forty-nine (45.4%) patients in the combination arm and 22 (20.4%) patients in the monotherapy arm achieved 6-month durable response (P < 0.001). The safety analysis set included patients who received at least one dose of study medication (n = 108 in the combination arm and n = 105 in the monotherapy arm). Fifty-two (48.1%) patients receiving baricitinib plus danazol and 47 (44.7%) patients receiving danazol alone reported at least one adverse event. Each arm reported two patients who developed an adverse event causing study discontinuation and one patient who developed a grade 3 or more severe adverse event. Low-dose baricitinib plus danazol might be a novel option for difficult-to-treat ITP. Funding: National Key Research and Development Program of China (No. 2023YFC2507800), National Natural Science Foundation of China (No. 82230004, No. 82430006, No. 82400157), Capital Health Development and Research of Special (No. 2022-1-4082), and Beijing Natural Science Foundation (No. 7242154 and No. 7232188). ClinicalTrials.gov identifier: NCT05852847.