Abstract：
OBJECTIVE: The safety profile of Janus Kinase (JAK) inhibitors has acquired attention due to post-marketing observed adverse drug reactions. The study focuses on the analysis of adverse reactions related to tofacitinib, baricitinib, upadacitinib, and filgotinib in rheumatoid arthritis patients, including identifying predictive factors linked to their occurrence.
METHODS: Observational retrospective study. Adult patients with rheumatoid arthritis from a university hospital receiving JAK inhibitor treatment between September 2017 and January 2024 were included. The cumulative incidence of each adverse reaction was calculated using the Naranjo scale. Risk factors for developing adverse reactions were identified through logistic regression analyses.
RESULTS: Two hundred twenty-three patients were included, with 28.7% presenting adverse reaction related to JAK inhibitor treatment. The adverse drug reactions with the highest cumulative incidence were infections and gastrointestinal disorders. Infections included: upper respiratory tract (4.5%), cellulitis (3.1%), urinary tract (2.7%), herpes zoster (1.8%). Gastrointestinal disorders comprised: abdominal pain (4.0%), diarrhea (3.6%), nausea and vomiting (3.6%), gastrointestinal perforation (1.3%), diverticulitis (0.9%). Classified at 0.5% were: headache, paresthesias, skin rash, severe neutropenia, insomnia, dyspnea, hypertensive crisis. As risk factors, were identified: the treatment with a non-selective JAK inhibitor (OR adjusted: 4.03; 95% CI: 1.15-14.10; P=.029) and older age (OR adjusted: 1.03; 95% CI: 1.00-1.05; P=.036).
CONCLUSIONS: Infections and gastrointestinal disorders represented the adverse reactions related to JAK inhibitor treatment with the highest cumulative incidence, with risk factors for their occurrence being non-selective JAK inhibitor treatment and older age of the patient.
METHODS: Observational retrospective study. Adult patients with rheumatoid arthritis from a university hospital receiving JAK inhibitor treatment between September 2017 and January 2024 were included. The cumulative incidence of each adverse reaction was calculated using the Naranjo scale. Risk factors for developing adverse reactions were identified through logistic regression analyses.
RESULTS: Two hundred twenty-three patients were included, with 28.7% presenting adverse reaction related to JAK inhibitor treatment. The adverse drug reactions with the highest cumulative incidence were infections and gastrointestinal disorders. Infections included: upper respiratory tract (4.5%), cellulitis (3.1%), urinary tract (2.7%), herpes zoster (1.8%). Gastrointestinal disorders comprised: abdominal pain (4.0%), diarrhea (3.6%), nausea and vomiting (3.6%), gastrointestinal perforation (1.3%), diverticulitis (0.9%). Classified at 0.5% were: headache, paresthesias, skin rash, severe neutropenia, insomnia, dyspnea, hypertensive crisis. As risk factors, were identified: the treatment with a non-selective JAK inhibitor (OR adjusted: 4.03; 95% CI: 1.15-14.10; P=.029) and older age (OR adjusted: 1.03; 95% CI: 1.00-1.05; P=.036).
CONCLUSIONS: Infections and gastrointestinal disorders represented the adverse reactions related to JAK inhibitor treatment with the highest cumulative incidence, with risk factors for their occurrence being non-selective JAK inhibitor treatment and older age of the patient.
摘要：
目的：由于上市后观察到的药物不良反应，Janus激酶（JAK）抑制剂的安全性受到关注。该研究的重点是分析与托法替尼相关的不良反应，baricitinib,upadacitinib,和类风湿关节炎患者的菲尔戈替尼，包括确定与其发生相关的预测因素。
方法：观察性回顾性研究。纳入了2017年9月至2024年1月接受JAK抑制剂治疗的大学医院类风湿关节炎成年患者。使用Naranjo量表计算每种不良反应的累积发生率。通过logistic回归分析确定发生不良反应的危险因素。
结果：纳入了223例患者，28.7%的患者出现与JAK抑制剂治疗相关的不良反应。累积发生率最高的药物不良反应是感染和胃肠道疾病。感染包括：上呼吸道（4.5％），蜂窝织炎（3.1%），泌尿道(2.7%),带状疱疹（1.8%）。胃肠道疾病包括：腹痛（4.0%），腹泻（3.6%），恶心和呕吐(3.6%),胃肠道穿孔（1.3%），憩室炎（0.9%）。按0.5%分类的是：头痛，感觉异常,皮疹,严重的中性粒细胞减少症,失眠,呼吸困难,高血压危象。作为风险因素，已确定：非选择性JAK抑制剂治疗（OR调整：4.03;95％CI：1.15-14.10;P=0.029）和年龄较大（OR调整：1.03;95％CI：1.00-1.05;P=.036）。
结论：感染和胃肠道疾病是与JAK抑制剂治疗相关的不良反应，累积发生率最高。其发生的危险因素是非选择性JAK抑制剂治疗和患者年龄较大。
方法：观察性回顾性研究。纳入了2017年9月至2024年1月接受JAK抑制剂治疗的大学医院类风湿关节炎成年患者。使用Naranjo量表计算每种不良反应的累积发生率。通过logistic回归分析确定发生不良反应的危险因素。
结果：纳入了223例患者，28.7%的患者出现与JAK抑制剂治疗相关的不良反应。累积发生率最高的药物不良反应是感染和胃肠道疾病。感染包括：上呼吸道（4.5％），蜂窝织炎（3.1%），泌尿道(2.7%),带状疱疹（1.8%）。胃肠道疾病包括：腹痛（4.0%），腹泻（3.6%），恶心和呕吐(3.6%),胃肠道穿孔（1.3%），憩室炎（0.9%）。按0.5%分类的是：头痛，感觉异常,皮疹,严重的中性粒细胞减少症,失眠,呼吸困难,高血压危象。作为风险因素，已确定：非选择性JAK抑制剂治疗（OR调整：4.03;95％CI：1.15-14.10;P=0.029）和年龄较大（OR调整：1.03;95％CI：1.00-1.05;P=.036）。
结论：感染和胃肠道疾病是与JAK抑制剂治疗相关的不良反应，累积发生率最高。其发生的危险因素是非选择性JAK抑制剂治疗和患者年龄较大。
