TNFα-inhibitors cycling with golimumab as second drug in inflammatory arthritis patients: Data from the multicenter GO-REAL registry

Carolina Ayelen Isnardi , Emma Estela Civit De Garignani , Agustín García Ciccarelli , Jimena Sanchez Alcover , Ingrid Strusberg , Marcos Baravalle , Sol Castaños , Liliana Morales , Matias Palombo , Eduardo Albiero , Carla Gobbi , Rodrigo Garcia Salinas , Sebastian Magri , Edson Velozo , Enrique R. Soriano , Alfredo Vargas Caselles , Luis Carlos Palomino Romero , Sergio Paira , Romina Calvo , Alberto Ortiz , Gustavo Citera
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Abstract

Introduction/Objectives

There are still controversies about the efficacy of cycling to a second tumor necrosis factor inhibitor (TNFi) in patients with inflammatory arthritis. The aim of this study was to evaluate survival, persistence and effectiveness of golimumab (GLM) in patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) with previous experience with other TNFi and to compare these results with TNFi naive patients.

Methods

Observational cohort of consecutive patients with RA, PsA and axSpA who had started treatment with GLM according to medical indication. bDMARD naive and TNFi experienced patients were selected.

Results

A total of 147 (62.3%) bDMARD naive and 45 (19.1%) TNFi experienced patients were included. Patients were followed up for a total of 441.5 patients/year, 55 (28.6%) discontinued GLM, 42 (28.6%) and 13 (28.9%) in each group, respectively (p = 0.967). The majority (63.6%) suspended due to inefficacy, followed by lack of access (23.6%) and adverse events (9.1%). Median GLM survival was 74.0 months (95% CI 57.0, 91.0) and 71.0 months (95% CI 37.0, 105.0), in the bDMARD naive and TNFi experienced patients, respectively (p = 0.695). Drug persistence at 6, 12, 24 and 36 months was 92.8%, 88.1%, 76.1%, 65.4% and 93.1%, 77.4%, 74.2%, 68.5%, respectively. In the multivariable analysis, having public health insurance was associated with higher risk of drug discontinuation (HR 2.56, 95% CI 1.28–5.00, p = 0.008). TNFi experienced patients did not show significantly higher risk of GLM suspension (HR 1.35, 95% CI 0.70–2.57, p = 0.370).

Conclusion

In this cohort, TNFi experienced patients had comparable survival and persistence of treatment with GLM. Having public health insurance was associated with lower drug retention rates.
tnf α-抑制剂在炎症性关节炎患者中作为第二种药物循环:来自多中心GO-REAL注册的数据
介绍/目的炎性关节炎患者循环使用第二种肿瘤坏死因子抑制剂(TNFi)的疗效仍存在争议。本研究的目的是评估golimumab (GLM)在类风湿关节炎(RA)、轴型脊柱炎(axSpA)和银屑病关节炎(PsA)患者中的生存、持久性和有效性,并将这些结果与TNFi初发患者进行比较。方法对按医学指征开始GLM治疗的连续RA、PsA和axSpA患者进行观察队列研究。选择bDMARD患者和有TNFi经验的患者。结果共纳入147例(62.3%)bDMARD初发患者和45例(19.1%)TNFi经验患者。共随访441.5例/年,两组停药患者分别为55例(28.6%)、42例(28.6%)和13例(28.9%)(p = 0.967)。大多数(63.6%)因无效而暂停,其次是缺乏获取(23.6%)和不良事件(9.1%)。bDMARD患者和TNFi患者的中位GLM生存期分别为74.0个月(95% CI 57.0, 91.0)和71.0个月(95% CI 37.0, 105.0) (p = 0.695)。6、12、24、36个月的药物持续率分别为92.8%、88.1%、76.1%、65.4%和93.1%、77.4%、74.2%、68.5%。在多变量分析中,拥有公共医疗保险与较高的停药风险相关(HR 2.56, 95% CI 1.28-5.00, p = 0.008)。经历过TNFi的患者没有显示出明显更高的GLM悬浮风险(HR 1.35, 95% CI 0.70-2.57, p = 0.370)。结论在这个队列中,经历过TNFi的患者具有相当的生存和GLM治疗的持久性。拥有公共医疗保险与较低的药物保留率有关。
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