Raimondo Vincenzo, Caminiti Maurizio, Olivo Domenico, Gigliotti Pietro, L'Andolina Massimo, Muto Pietro, Pellegrini Roberta, Varcasia Giuseppe, Bruno Caterina, Massaro Laura, Pagano Mariano Giuseppa, Luppino Jessica Maria Elisa, Cirillo Mariateresa, Caira Virginia, Calabria Marilena, Ciaffi Jacopo, Ferri Clodoveo, Ursini Francesco
Rheumatology Clinic, ASP Crotone, 88836 Crotone, Italy.
Rheumatology Unit, Grande Ospedale Metropolitano, 89124 Reggio Calabria, Italy.
J Clin Med. 2024 Nov 27;13(23):7185. doi: 10.3390/jcm13237185.
Janus kinase inhibitors (JAKis) are a novel class of drugs interfering with intracellular signaling of type I and type II cytokines, which play a crucial role in immune dysregulation associated with several chronic inflammatory diseases. Filgotinib (FIL), in particular, is the newest member of the JAKi class and exerts its therapeutic effects by selectively targeting and inhibiting the kinase activity of JAK1. While the efficacy of FIL in rheumatoid arthritis (RA) has been confirmed in clinical trials, real-world evidence may provide better insights into its effectiveness and safety in routine clinical practice. We performed a multicenter, retrospective cohort study investigating the real-life effectiveness and safety of FIL in adult patients with RA. Demographic information, disease characteristics, prior treatment history, and comorbid conditions were retrieved from clinical records at baseline (M0) and after 3 (M3) and 6 months (M6) of treatment. A total of 82 patients (63 women) agreed to participate in the study, of whom 39 (47.6%) were older than 65 years. The average RA duration was 13 ± 9 years; 19 patients (23.1%) were current or former smokers, and 4 patients (4.9%) had a history of cardiovascular events. Most patients had previously received at least one biologic disease-modifying antirheumatic drug (range: 1-6+); in addition, 11 patients (13.4%) had been already exposed to another JAKi. During the follow-up, 7 patients discontinued treatment due to primary failure ( = 3) or adverse events ( = 4). Significant reductions in pain and number of tender and swollen joints were observed at M3 and M6. A relevant proportion of patients achieved DAS28-CRP remission at M3 and M6 (46.3% and 66.2%, respectively). Our data provide additional insight into the effectiveness of filgotinib in a real-world setting, even among patients with difficult-to-treat RA and a high prevalence of cardiovascular risk factors.
Janus激酶抑制剂(JAKi)是一类新型药物,可干扰I型和II型细胞因子的细胞内信号传导,这些细胞因子在与多种慢性炎症性疾病相关的免疫失调中起关键作用。特别是非戈替尼(FIL),它是JAKi类药物中的最新成员,通过选择性靶向和抑制JAK1的激酶活性发挥其治疗作用。虽然FIL在类风湿性关节炎(RA)中的疗效已在临床试验中得到证实,但真实世界的证据可能会为其在常规临床实践中的有效性和安全性提供更好的见解。我们进行了一项多中心回顾性队列研究,调查FIL在成年RA患者中的实际有效性和安全性。从基线(M0)以及治疗3个月(M3)和6个月(M6)后的临床记录中获取人口统计学信息、疾病特征、既往治疗史和合并症情况。共有82例患者(63例女性)同意参与研究,其中39例(47.6%)年龄超过65岁。RA的平均病程为13±9年;19例患者(23.1%)为现吸烟者或既往吸烟者,4例患者(4.9%)有心血管事件史。大多数患者此前至少接受过一种生物改善病情抗风湿药物治疗(范围:1 - 6种以上);此外,11例患者(13.4%)已经接触过另一种JAKi。在随访期间,7例患者因原发性失败(n = 3)或不良事件(n = 4)停止治疗。在M3和M6时观察到疼痛以及压痛和肿胀关节数量显著减少。相当比例的患者在M3和M6时达到DAS28-CRP缓解(分别为46.3%和66.2%)。我们的数据为非戈替尼在真实世界环境中的有效性提供了更多见解,即使在难治性RA和心血管危险因素患病率高的患者中也是如此。