Reumatologia, Dipartimento di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Italy.
Sezione di Reumatologia, Dipartimento di Medicina, Università di Perugia, Italy.
Clin Exp Rheumatol. 2021 May-Jun;39(3):525-531. doi: 10.55563/clinexprheumatol/lfg83z. Epub 2020 Dec 18.
Baricitinib is a Janus-kinase (JAK) 1/2 inhibitor, approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) patients with inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). We report the first real-life experience with baricitinib in a monocentric cohort of unselected RA patients.
We enrolled consecutive RA patients starting baricitinib. At baseline and after 4, 12, 24 and 48 weeks we assessed the disease activity by composite indices (SDAI, CDAI and DAS28CRP) and ultrasonography, and we recorded any adverse events. The primary endpoint was the percentage of patients achieving SDAI remission at week 4.
We enrolled 59 patients [(F:M = 50:9, median age 58.1 years (IQR 12.8), median disease duration 144 (IQR 150) months] treated with baricitinib in combination with a csDMARD (52.5%) or monotherapy (47.5%) for a median follow-up of 24 weeks (IQR 36). The 12-month drug retention rate was 74%. At weeks 4, 12, 24 and 48 we observed a significant reduction of DAS28, CDAI and SDAI, global health and pain (p<0.001 for all). After 4 weeks of treatment, 12% of patients achieved SDAI remission. Concomitant csDMARDs, previous biological DMARDs, gender, seropositivity and BMI did not affect the efficacy of baricitinib. Baricitinib allowed a significant reduction in prednisone dose after 12 and 24 weeks and a rapid and sustained ultrasound improvement. No serious adverse events, serious infections or cardiovascular events were recorded.
Our study confirms the efficacy and safety profile and rapid onset of the effect of baricitinib in RA patients in a real-life setting.
巴瑞替尼是一种 Janus 激酶（JAK）1/2 抑制剂，已被批准用于治疗对常规合成疾病修饰抗风湿药物（csDMARDs）反应不足的中重度类风湿关节炎（RA）患者。我们报告了巴瑞替尼在一个未经选择的 RA 患者的单中心队列中的首个真实世界经验。
我们招募了开始接受巴瑞替尼治疗的连续 RA 患者。在基线和第 4、12、24 和 48 周时，我们使用综合指标（SDAI、CDAI 和 DAS28CRP）和超声评估疾病活动，并记录任何不良事件。主要终点是第 4 周时达到 SDAI 缓解的患者比例。
我们招募了 59 名患者[（F：M=50：9，中位年龄 58.1 岁（IQR 12.8），中位疾病持续时间 144（IQR 150）个月]，巴瑞替尼联合 csDMARD（52.5%）或单药治疗（47.5%），中位随访时间为 24 周（IQR 36）。12 个月的药物保留率为 74%。在第 4、12、24 和 48 周时，我们观察到 DAS28、CDAI 和 SDAI、总体健康和疼痛显著降低（所有 P<0.001）。在治疗 4 周后，12%的患者达到了 SDAI 缓解。同时使用 csDMARDs、以前使用生物 DMARDs、性别、血清阳性和 BMI 并不影响巴瑞替尼的疗效。巴瑞替尼在 12 和 24 周后允许显著减少泼尼松剂量，并迅速和持续改善超声。没有记录到严重不良事件、严重感染或心血管事件。
我们的研究在真实环境中证实了巴瑞替尼在 RA 患者中的疗效和安全性，并证实了其快速起效。
