Abstract：
The majority of patients with a rheumatic disease treated with etanercept may be overexposed. Data regarding etanercept tapering are scarce, particularly in psoriatic arthritis (PsA) and ankylosing spondylitis (AS). We compared extending the dose interval to continuation of the standard dose and studied the success rate of etanercept discontinuation. Etanercept concentrations were measured throughout the study.
160 patients with rheumatoid arthritis (RA), PsA, or AS with sustained minimal disease activity (MDA) were enrolled in this 18-month, open-label, randomized controlled trial. The intervention group doubled the dosing interval at baseline and discontinued etanercept 6 months later. The control group continued the standard dose for 6 months and doubled the dosing-interval thereafter. The primary outcome was the proportion of patients maintaining MDA at 6 month follow-up.
At 6 months, MDA status was maintained in 47 patients (63%) in the intervention group and 56 (74%) in the control group (p = 0.15), with comparable results in all rheumatic diseases. And median etanercept concentrations decreased from 1.50 µg/mL (interquartile range 1.06- 2.65) to 0.46 µg/mL (0.28-0.92). In total, 40% discontinued etanercept successfully with maintained MDA for at least 6 months.
Etanercept tapering can be done without losing efficacy in RA, PsA, and AS patients in sustained MDA. A substantial proportion of patients could stop etanercept for at least 6 months. In many patients, low drug concentrations proved sufficient to control disease activity. However, the risk of minor and major flares is substantial, even in patients continuing standard dosing.
160 patients with rheumatoid arthritis (RA), PsA, or AS with sustained minimal disease activity (MDA) were enrolled in this 18-month, open-label, randomized controlled trial. The intervention group doubled the dosing interval at baseline and discontinued etanercept 6 months later. The control group continued the standard dose for 6 months and doubled the dosing-interval thereafter. The primary outcome was the proportion of patients maintaining MDA at 6 month follow-up.
At 6 months, MDA status was maintained in 47 patients (63%) in the intervention group and 56 (74%) in the control group (p = 0.15), with comparable results in all rheumatic diseases. And median etanercept concentrations decreased from 1.50 µg/mL (interquartile range 1.06- 2.65) to 0.46 µg/mL (0.28-0.92). In total, 40% discontinued etanercept successfully with maintained MDA for at least 6 months.
Etanercept tapering can be done without losing efficacy in RA, PsA, and AS patients in sustained MDA. A substantial proportion of patients could stop etanercept for at least 6 months. In many patients, low drug concentrations proved sufficient to control disease activity. However, the risk of minor and major flares is substantial, even in patients continuing standard dosing.
摘要：
未经证实：大多数接受依那西普治疗的风湿性疾病患者可能过度暴露。关于etanercept逐渐减少的数据很少，特别是银屑病关节炎（PsA）和强直性脊柱炎（AS）。我们比较了延长剂量间隔到标准剂量的延续，并研究了依那西普停药的成功率。在整个研究中测量依那西普浓度。
未经授权：160例类风湿关节炎（RA）患者，PsA,在这18个月内纳入或具有持续微小疾病活动（MDA）的AS，开放标签，随机对照试验。干预组在基线时将给药间隔加倍，并在6个月后停用依那西普。对照组继续标准剂量6个月，此后给药间隔加倍。主要结果是在6个月随访时维持MDA的患者比例。
未经批准：在6个月时，干预组47例患者（63%）和对照组56例患者（74%）（p=0.15）保持MDA状态，在所有风湿性疾病中具有可比性的结果。依那西普浓度中位数从1.50µg/mL（四分位数范围1.06-2.65）降至0.46µg/mL（0.28-0.92）。总的来说,40％的人成功停用依那西普，并维持MDA至少6个月。
未经ASSIGNED：可以在RA中不丧失疗效的情况下进行Etanercept逐渐减少，PsA,和AS患者持续MDA。相当比例的患者可以停用依那西普至少6个月。在许多患者中，低药物浓度足以控制疾病活动。然而,轻微和主要耀斑的风险很大，即使在患者持续标准剂量。
未经授权：160例类风湿关节炎（RA）患者，PsA,在这18个月内纳入或具有持续微小疾病活动（MDA）的AS，开放标签，随机对照试验。干预组在基线时将给药间隔加倍，并在6个月后停用依那西普。对照组继续标准剂量6个月，此后给药间隔加倍。主要结果是在6个月随访时维持MDA的患者比例。
未经批准：在6个月时，干预组47例患者（63%）和对照组56例患者（74%）（p=0.15）保持MDA状态，在所有风湿性疾病中具有可比性的结果。依那西普浓度中位数从1.50µg/mL（四分位数范围1.06-2.65）降至0.46µg/mL（0.28-0.92）。总的来说,40％的人成功停用依那西普，并维持MDA至少6个月。
未经ASSIGNED：可以在RA中不丧失疗效的情况下进行Etanercept逐渐减少，PsA,和AS患者持续MDA。相当比例的患者可以停用依那西普至少6个月。在许多患者中，低药物浓度足以控制疾病活动。然而,轻微和主要耀斑的风险很大，即使在患者持续标准剂量。
