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Abstract：
Objectives: The objective of this study was to evaluate the real-world drug survival, adherence, and discontinuation risk of biologics disease-modifying anti-rheumatic drugs (bDMARDs) among patients with ankylosing spondylitis (AS). Methods: This was a retrospective study using a computerized database. Biologic-naïve and biologic-experienced AS patients who initiated treatment with bDMARDs (tumor necrosis factor alpha inhibitors {TNF-αis} or interleukin-17 inhibitor {IL-17i}) during 2015-2018 were included. Adherence was assessed using the proportion of days covered (PDC) method. Drug survival was analyzed using Kaplan-Meier estimates. Risk of discontinuation was estimated by the Cox proportional hazard model. Results: We identified 343 eligible patients utilizing 481 lines of therapy. The mean age was 44.6 years (SD ± 13.4), 57.7% were males, and 69.7% were biologic-naïve at baseline. The proportion of highly adherent patients (PDC ≥ 0.8) in the biologic-naïve group was 63.5% for golimumab, 69.2% for etanercept, and 71.6% for adalimumab (p > 0.9). Among the biologic-experienced group, secukinumab had the highest proportion of adherent patients (75.7%) and etanercept the lowest (50.0%) reaching statistical difference (p < 0.001). The Kaplan-Meier analysis did not show a significant difference in drug survival in either the biologic-naïve or the biologic-experienced groups (p = 0.85). Multivariable analysis demonstrated a similar risk for discontinuation for etanercept, golimumab, and secukinumab compared with adalimumab, regardless of biologic-experience status. Conclusions: Adherence, drug survival, and risk for discontinuation were similar for all TNF-αis and the IL-17i SEC, regardless of biologic-experience status. As drug survival is an indirect measure of drug efficacy, n, in real-world settings, we believe caregivers can integrate these results into treatment considerations.
摘要：
目的：本研究的目的是评估真实世界的药物生存，坚持,以及强直性脊柱炎（AS）患者停用生物制剂疾病缓解抗风湿药（bDMARDs）的风险。方法：这是一项使用计算机数据库的回顾性研究。纳入了2015-2018年期间开始使用bDMARDs（肿瘤坏死因子α抑制剂{TNF-αis}或白介素-17抑制剂{IL-17i}）治疗的未接受生物学和有生物学经验的AS患者。使用覆盖天数比例(PDC)方法评估依从性。使用Kaplan-Meier估计分析药物存活率。停药风险由Cox比例风险模型估计。结果：我们使用481种治疗线确定了343名合格患者。平均年龄为44.6岁（SD±13.4），57.7%为男性，基线时，69.7%为生物性未治疗。戈利木单抗在生物制剂初治组中高度粘附患者（PDC≥0.8）的比例为63.5％，依那西普69.2%，阿达木单抗为71.6%(p>0.9)。在有生物经验的群体中，粘附患者中苏金单抗的比例最高(75.7%),依那西普的比例最低(50.0%),差异有统计学意义(p<0.001).Kaplan-Meier分析未显示在未接受生物制剂或有生物制剂经验的组中药物存活率的显著差异(p=0.85)。多变量分析表明停药依那西普的风险相似，戈利木单抗,苏金单抗与阿达木单抗相比，无论生物经验状态如何。结论：坚持，药物生存,所有TNF-α和IL-17iSEC的停药风险相似，无论生物经验状态如何。由于药物生存是药物疗效的间接测量，n,在现实世界中，我们相信护理人员可以将这些结果纳入治疗考虑。
