Servicio de Farmacia, Hospital de la Santa Creu i Sant Pau, Barcelona, España; Departamento de Medicina, Universitat Autònoma de Barcelona (UAB), Bellaterra, España.
Departamento de Medicina, Universitat Autònoma de Barcelona (UAB), Bellaterra, España; Servicio de Urgencias, Hospital de la Santa Creu i Sant Pau, Barcelona, España.
Med Clin (Barc). 2024 Oct 25;163(8):391-396. doi: 10.1016/j.medcli.2024.05.007. Epub 2024 Jul 14.
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.
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.
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).
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.
由于上市后观察到的药物不良反应，Janus 激酶（JAK）抑制剂的安全性备受关注。本研究侧重于分析类风湿关节炎患者接受托法替布、巴瑞替尼、乌帕替尼和菲戈替尼治疗时与药物相关的不良反应，包括确定与不良反应发生相关的预测因素。
这是一项观察性回顾性研究。纳入了 2017 年 9 月至 2024 年 1 月期间在一家大学医院接受 JAK 抑制剂治疗的成年类风湿关节炎患者。使用 Naranjo 量表计算每种不良反应的累积发生率。通过逻辑回归分析确定发生不良反应的危险因素。
共纳入 223 例患者，其中 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为感染和胃肠道疾病。感染包括：上呼吸道感染（4.5%）、蜂窝织炎（3.1%）、尿路感染（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%）。发生率为 0.5%的不良反应有：头痛、感觉异常、皮疹、严重中性粒细胞减少、失眠、呼吸困难、高血压危象。作为危险因素，发现：使用非选择性 JAK 抑制剂治疗（调整后的 OR：4.03；95%CI：1.15-14.10；P=.029）和患者年龄较大（调整后的 OR：1.03；95%CI：1.00-1.05；P=.036）。
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。
