Rheumatology and Clinical Immunology, Humanitas Research Hospital IRCCS, Rozzano, Milan, Italy.
Rheumatology, Azienda Ospedaliera Universitaria Integrata, Verona, University of Verona, Italy.
Clin Exp Rheumatol. 2021 Jul-Aug;39(4):868-873. doi: 10.55563/clinexprheumatol/pudtpo. Epub 2020 Dec 18.
Baricitinib, an oral Janus kinase (JAK) 1-2 inhibitor, is currently used along biologic DMARDs (bDMARDs) after the failure of methotrexate (MTX) in rheumatoid arthritis (RA). We investigated the efficacy and safety of baricitinib in real life.
We prospectively enrolled 446 RA patients treated with baricitinib from 11 Italian centres. Patients were evaluated at baseline and after 3, 6, and 12 months. They were arrayed based on previous treatments as bDMARD-naïve and bDMARD-insufficient responders (IR) after the failure or intolerance to bDMARDs. A sub-analysis differentiated the effects of methotrexate (MTX) and the use of oral glucocorticoids (OGC).
Our cohort included 150 (34%) bDMARD-naïve and 296 (66%) bDMARD-IR patients, with 217 (49%) using baricitinib as monotherapy. Considering DAS-28-CRP as the primary outcome, at 3 and 6 months, 114/314 (36%) and 149/289 (51.6%) patients achieved remission, while those in low disease activity (LDA) were 62/314 (20%) and 46/289 (15.9%), respectively; finally at 12 months 81/126 (64%) were in remission and 21/126 (17%) in LDA. At all-timepoints up to 12 months, bDMARDs-naïve patients demonstrated a better clinical response, independently of MTX. A significant reduction in the OGC dose was observed at 3 and 12 months in all groups. The serum positivity for both rheumatoid factors (RF) and anti-citrullinated protein antibodies (ACPA) conferred a lower risk of stopping baricitinib due to inefficacy. Fifty-eight (13%) patients discontinued baricitinib due to adverse events, including thrombotic events and herpes zoster reactivation.
Real-life data confirm the efficacy and safety profiles of baricitinib in patients with RA and provide evidence that drug survival is higher in bDMARDs-naïve and seropositive patients.
巴利昔替尼是一种口服 JAK1-2 抑制剂，在甲氨蝶呤（MTX）治疗类风湿关节炎（RA）失败后，与生物 DMARD（bDMARD）联合使用。我们研究了巴利昔替尼在真实世界中的疗效和安全性。
我们前瞻性地招募了来自意大利 11 个中心的 446 例接受巴利昔替尼治疗的 RA 患者。患者在基线时和治疗后 3、6 和 12 个月进行评估。他们根据之前的治疗方案分为 bDMARD 初治和 bDMARD 疗效不足的应答者（IR），即在 bDMARD 治疗失败或不耐受后。一项亚分析区分了 MTX 和口服糖皮质激素（OGC）的作用。
我们的队列包括 150 例（34%）bDMARD 初治和 296 例（66%）bDMARD-IR 患者，其中 217 例（49%）患者使用巴利昔替尼单药治疗。以 DAS28-CRP 作为主要结局，在 3 个月和 6 个月时，314 例患者中有 114 例（36%）和 289 例患者中有 149 例（51.6%）达到缓解，而低疾病活动度（LDA）患者分别为 62 例和 46 例（20%和 15.9%）；最终在 12 个月时，126 例患者中有 81 例（64%）达到缓解，126 例中有 21 例（17%）达到 LDA。在所有时间点，直到 12 个月，bDMARD 初治患者表现出更好的临床反应，与 MTX 无关。所有组在 3 个月和 12 个月时均观察到 OGC 剂量显著减少。血清类风湿因子（RF）和抗瓜氨酸蛋白抗体（ACPA）阳性与因疗效不佳而停止使用巴利昔替尼的风险较低相关。58 例（13%）患者因不良反应（包括血栓事件和带状疱疹再激活）停止使用巴利昔替尼。
真实世界的数据证实了巴利昔替尼在 RA 患者中的疗效和安全性，并提供了证据表明，在 bDMARD 初治和血清阳性患者中，药物存活率更高。
