ReLiFiRa（类风湿关节炎中真实世界的非戈替尼）：常见临床实践中疗效与安全性的回顾性研究
ReLiFiRa (Real Life Filgotinib in Rheumatoid Arthritis): Retrospective Study of Efficacy and Safety in Common Clinical Practice.
作者信息
Benucci Maurizio, Bardelli Marco, Cazzato Massimiliano, Laurino Elenia, Bartoli Francesca, Damiani Arianna, Li Gobbi Francesca, Panaccione Anna, Di Cato Luca, Niccoli Laura, Frediani Bruno, Mosca Marta, Guiducci Serena, Cantini Fabrizio
机构信息
Rheumatology Unit, San Giovanni di Dio Hospital, 50143 Florence, Italy.
Rheumatology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, 53100 Siena, Italy.
出版信息
J Pers Med. 2023 Aug 25;13(9):1303. doi: 10.3390/jpm13091303.
BACKGROUND
Filgotinib (FIL) is a selective JAK1 inhibitor with an affinity 30-fold higher than JAK2, approved to treat moderate to severe active rheumatoid arthritis (RA), in adults with inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
METHODS
We conducted a retrospective, multicentric study in order to evaluate efficacy and safety of FIL 200 mg daily therapy, after 3 and 6 months, in 120 patients affected by RA, managed in Tuscany and Umbria rheumatological centers. The following clinical records were analyzed: demographical data, smoking status, previous presence of comorbidities (Herpes zoster -HZ- infection, venous thromboembolism -VTE-, major adverse cardiovascular events -MACE-, cancer, diabetes, and hypertension), disease duration, presence of anti-citrullinated protein antibodies (ACPA), rheumatoid factor (RF), number of biological failures, and prior csDMARDs utilized. At baseline, and after 3 (T3) and 6 (T6) months of FIL therapy, we evaluated mean steroid dosage, csDMARDs intake, clinimetric indexes (DAS28, CDAI, HAQ, patient and doctor PGA, VAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and body mass index (BMI).
RESULTS
At baseline, the mean disease duration was 9.4 ± 7.5 years; the prevalence of previous HZ infection, VTE, MACE, and cancer was respectively 4.12%, 0%, 7.21%, and 0.83%, respectively. In total, 76.3% of patients failed one or more biologics (one biological failure, 20.6%; two biological failures, 27.8%; three biological failures, 16.5%; four biological failures, 10.3%; five biological failures, 1.1%). After 3 months of FIL therapy, all clinimetric index results significantly improved from baseline, as well as after 6 months. Also, ESR and CRP significatively decreased at T3 and T6. Two cases of HZ were recorded, while no new MACE, VTE, or cancer were recorded during the observation time.
CONCLUSION
Despite the limitations of the retrospective study and of the observational period of only 6 months, real-life data on the treatment of RA patients with FIL demonstrate that this Jak inhibitor therapy is safe in terms of CV, VTE events, and occurrence of cancer, and is also effective in a population identified as "difficult to treat" due to failure of previous b-DMARD therapy.
背景
非戈替尼（FIL）是一种选择性JAK1抑制剂，其对JAK1的亲和力比对JAK2高30倍，已被批准用于治疗对一种或多种改善病情抗风湿药物（DMARDs）反应不足或不耐受的中度至重度活动性类风湿关节炎（RA）成人患者。
方法
我们进行了一项回顾性多中心研究，以评估在托斯卡纳和翁布里亚风湿病中心接受治疗的120例RA患者中，每日200 mg非戈替尼治疗3个月和6个月后的疗效和安全性。分析了以下临床记录：人口统计学数据、吸烟状况、既往合并症（带状疱疹-HZ-感染、静脉血栓栓塞-VTE-、主要不良心血管事件-MACE-、癌症、糖尿病和高血压）、病程、抗瓜氨酸化蛋白抗体（ACPA）、类风湿因子（RF）的存在情况、生物制剂治疗失败的次数以及先前使用的传统合成DMARDs。在基线时以及非戈替尼治疗3个月（T3）和6个月（T6）后，我们评估了平均类固醇剂量、传统合成DMARDs的摄入量、临床指标（DAS28、CDAI、HAQ、患者和医生的PGA、VAS）、红细胞沉降率（ESR）、C反应蛋白（CRP）和体重指数（BMI）。
结果
基线时，平均病程为9.4±7.5年；既往HZ感染、VTE、MACE和癌症的患病率分别为4.12%、0%、7.21%和0.83%。总共有76.3%的患者一种或多种生物制剂治疗失败（一次生物制剂治疗失败，20.6%；两次生物制剂治疗失败，27.8%；三次生物制剂治疗失败，16.5%；四次生物制剂治疗失败，10.3%；五次生物制剂治疗失败，1.1%）。非戈替尼治疗3个月后，所有临床指标结果均较基线显著改善，6个月后亦是如此。此外，ESR和CRP在T3和T6时显著下降。记录到2例HZ病例，而在观察期内未记录到新的MACE、VTE或癌症病例。
结论
尽管该回顾性研究存在局限性且观察期仅6个月，但关于非戈替尼治疗RA患者的真实世界数据表明，这种JAK抑制剂治疗在心血管、VTE事件和癌症发生方面是安全的，并且对因先前b-DMARD治疗失败而被认定为“难治”的人群也有效。
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