Department of Rheumatology, Osaki Citizen Hospital, Osaki, Japan.
Department of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Int J Rheum Dis. 2022 Mar;25(3):335-343. doi: 10.1111/1756-185X.14281. Epub 2022 Jan 6.
To investigate 6-year drug survival (median: 48.5 months) of golimumab and predictors for lack of efficacy leading to golimumab discontinuation in Japanese patients with rheumatoid arthritis (RA) in routine practice.
This retrospective single-center study included 60 patients with RA treated with golimumab from November 2011 to August 2020. Patients were divided into 2 groups (retention, n = 28; withdrawal due to lack of efficacy, n = 24). The retention rate was assessed using the Kaplan-Meier method, and variables associated with golimumab discontinuation were identified using the Cox proportional hazard model.
The prevalence of concomitant methotrexate and no biologics use was significantly higher in the retention than in the withdrawal group. Overall drug survival of golimumab was 66.3%, 48.3%, and 24.5% at 12, 36, and 72 months, respectively. There were statistical differences in retention rates among groups stratified by initiation dose, methotrexate, and biologics use. Multivariate analysis revealed the factor associated with golimumab discontinuation as history of 1 (hazards ratio: 4.42, 95% CI: 1.35-19.93, P = .012) and ≥2 biologics use (7.49, 1.97-36.27, P = .003).
Prior exposure of increasing number of biologics was identified as the most important factor negatively affecting long-term golimumab retention in Japanese patients with RA.
评估在常规临床实践中,日本类风湿关节炎(RA)患者使用戈利木单抗的 6 年药物(中位:48.5 个月)生存率,以及导致戈利木单抗停药的无应答预测因素。
本回顾性单中心研究纳入了 2011 年 11 月至 2020 年 8 月期间使用戈利木单抗治疗的 60 例 RA 患者。患者分为两组(保留组,n=28;因无应答而停药组,n=24)。采用 Kaplan-Meier 法评估保留率,采用 Cox 比例风险模型识别与戈利木单抗停药相关的变量。
保留组同时使用甲氨蝶呤和未使用生物制剂的患者比例明显高于停药组。戈利木单抗的总体药物生存率分别为 12、36 和 72 个月时的 66.3%、48.3%和 24.5%。根据起始剂量、甲氨蝶呤和生物制剂的使用情况对各组进行分层,保留率存在统计学差异。多变量分析显示,戈利木单抗停药的相关因素为既往使用 1(风险比:4.42,95%CI:1.35-19.93,P=0.012)和≥2 种生物制剂(7.49,1.97-36.27,P=0.003)。
既往使用越来越多生物制剂的经历被确定为影响日本 RA 患者长期保留戈利木单抗的最重要负面因素。