Boussaid Soumaya, Tbini Houssem, Rekik Sonia, Khaled Saadaoui, Rahmouni Safa, Zouaoui Khaoula, Riahi Salem, Sahli Hela, Elleuch Mohamed
Rheumatology Department, La Rabta Hospital, Tunis, Tunisia.
Faculty of Medicine of Tunis, University Tunis el Manar, Tunis, Tunisia.
Mediterr J Rheumatol. 2024 Jan 31;35(3):448-458. doi: 10.31138/mjr.090723.pof. eCollection 2024 Sep.
This study aims to investigate the efficacy and tolerance of biologic disease-modifying anti-rheumatic drug (bDMARDs) in the current management of rheumatoid arthritis (RA) by identifying the retention time and survival rate of bDMARDs.
We conducted a retrospective cohort study including Tunisian patients initiating bDMARD treatment between 2016 and 2018 whose data were collected from the National Health Insurance Fund (NHIF). The NHIF is the national office which organises and centralises patients under bDMARDs from all over the country. Retention and survival rate of bDMARDs at 48 months were analysed using Kaplan-Meier survival curves and compared using the log-rank test. Survival factor analysis was performed using Cox regression.
Three hundred seventy-four patients, aged 55.5±12.5years [20-90], (87.2%women), were included. The mean duration of RA was 11.7±6.7 years [2-41]. The mean disease activity score (DAS)28 at initiation of the first bDMARD was 6.01±0.89 [5.37-6.5]. This first bDMARD induced low disease activity (LDA) in 55% of cases. Remission was observed in 28% of patients. The highest LDA and remission rates were observed with Tocilizumab (70.8% and 33.3% of cases, respectively). LDA and remission were achieved within a mean of 45 weeks [26-88] and 72 weeks [31-117] respectively. The 48-month first-line survival rate was 55.9%. Retention time was 41.7 months, 95%CI [39.47-43.91]. Presence of rheumatoid factors, co-prescription of methotrexate, and good initial therapeutic response were factors influencing better survival of bDMARDs (p<0.01). Glucocorticoid use predicted poorer survival (p<10-3). The first bDMARD was interrupted in 39% of cases. Ineffectiveness was the most common cause of treatment cessation (52.7%).
This real-life study of the Tunisian population allowed us to establish the factors that can influence the survival and retention rates of bDMARDs.
本研究旨在通过确定生物改善病情抗风湿药物(bDMARDs)的保留时间和生存率,探讨其在类风湿关节炎(RA)当前治疗中的疗效和耐受性。
我们进行了一项回顾性队列研究,纳入了2016年至2018年间开始接受bDMARD治疗的突尼斯患者,其数据来自国家健康保险基金(NHIF)。NHIF是负责组织和集中全国接受bDMARDs治疗患者信息的国家机构。使用Kaplan-Meier生存曲线分析bDMARDs在48个月时的保留率和生存率,并使用对数秩检验进行比较。使用Cox回归进行生存因素分析。
共纳入374例患者,年龄55.5±12.5岁[20 - 90岁],女性占87.2%。RA的平均病程为11.7±6.7年[2 - 41年]。首次使用bDMARD时的平均疾病活动评分(DAS)28为6.01±0.89[5.37 - 6.5]。首次使用的bDMARD在55%的病例中诱导了低疾病活动度(LDA)。28%的患者达到缓解。托珠单抗的LDA和缓解率最高(分别为70.8%和33.3%的病例)。LDA和缓解分别在平均45周[26 - 88周]和72周[31 - 117周]内实现。48个月的一线生存率为55.9%。保留时间为41.7个月,95%置信区间[39.47 - 43.91]。类风湿因子的存在、甲氨蝶呤的联合处方以及良好的初始治疗反应是影响bDMARDs更好生存的因素(p<0.01)。使用糖皮质激素预示着较差的生存率(p<10 - 3)。39%的病例中首次使用的bDMARD被中断。无效是治疗停止的最常见原因(52.7%)。
这项针对突尼斯人群的真实研究使我们能够确定影响bDMARDs生存率和保留率的因素。