Department of Pediatric Immunology and Rheumatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, P.O. box 85090, 3508 AB, Utrecht, The Netherlands.
Faculty of Medicine, Utrecht University, Utrecht, the Netherlands.
Pediatr Rheumatol Online J. 2022 Nov 14;20(1):96. doi: 10.1186/s12969-022-00763-x.
Etanercept (ETN) and adalimumab (ADA) are considered equally effective biologicals in the treatment of arthritis in juvenile idiopathic arthritis (JIA) but no studies have compared their impact on patient-reported well-being. The objective of this study was to determine whether ETN and ADA have a differential effect on patient-reported well-being in non-systemic JIA using real-world data.
Biological-naive patients without a history of uveitis were selected from the international Pharmachild registry. Patients starting ETN were matched to patients starting ADA based on propensity score and outcomes were collected at time of therapy initiation and 3-12 months afterwards. Primary outcome at follow-up was the improvement in Juvenile Arthritis Multidimensional Assessment Report (JAMAR) visual analogue scale (VAS) well-being score from baseline. Secondary outcomes at follow-up were decrease in active joint count, adverse events and uveitis events. Outcomes were analyzed using linear and logistic mixed effects models.
Out of 158 eligible patients, 45 ETN starters and 45 ADA starters could be propensity score matched resulting in similar VAS well-being scores at baseline. At follow-up, the median improvement in VAS well-being was 2 (interquartile range (IQR): 0.0 - 4.0) and scores were significantly better (P = 0.01) for ETN starters (median 0.0, IQR: 0.0 - 1.0) compared to ADA starters (median 1.0, IQR: 0.0 - 3.5). The estimated mean difference in VAS well-being improvement from baseline for ETN versus ADA was 0.89 (95% CI: -0.01 - 1.78; P = 0.06). The estimated mean difference in active joint count decrease was -0.36 (95% CI: -1.02 - 0.30; P = 0.28) and odds ratio for adverse events was 0.48 (95% CI: 0.16 -1.44; P = 0.19). One uveitis event was observed in the ETN group.
Both ETN and ADA improve well-being in non-systemic JIA. Our data might indicate a trend towards a slightly stronger effect for ETN, but larger studies are needed to confirm this given the lack of statistical significance.
依那西普(ETN)和阿达木单抗(ADA)在治疗幼年特发性关节炎(JIA)中被认为同样有效,但尚无研究比较它们对患者报告的健康状况的影响。本研究的目的是使用真实世界数据确定 ETN 和 ADA 是否对非全身型 JIA 患者的报告健康状况有不同的影响。
从国际 Pharmachild 注册处选择无葡萄膜炎病史的生物初治患者。根据倾向评分匹配开始使用 ETN 的患者和开始使用 ADA 的患者,并在治疗开始时和 3-12 个月后收集结果。随访时的主要结局是青少年关节炎多维评估报告(JAMAR)视觉模拟量表(VAS)健康状况评分从基线的改善。随访时的次要结局为活跃关节计数、不良事件和葡萄膜炎事件的减少。使用线性和逻辑混合效应模型分析结果。
在 158 名符合条件的患者中,45 名 ETN 起始者和 45 名 ADA 起始者可进行倾向评分匹配,从而使基线 VAS 健康状况评分相似。随访时,VAS 健康状况的中位数改善为 2(四分位距(IQR):0.0-4.0),ETN 起始者(中位数 0.0,IQR:0.0-1.0)的评分明显更好(P=0.01),而 ADA 起始者(中位数 1.0,IQR:0.0-3.5)。ETN 与 ADA 相比,从基线 VAS 健康状况改善的估计平均差异为 0.89(95%CI:-0.01-1.78;P=0.06)。活跃关节计数减少的估计平均差异为-0.36(95%CI:-1.02-0.30;P=0.28),不良事件的比值比为 0.48(95%CI:0.16-1.44;P=0.19)。ETN 组观察到 1 例葡萄膜炎事件。
ETN 和 ADA 均可改善非全身型 JIA 的健康状况。我们的数据可能表明 ETN 的作用略有增强,但鉴于缺乏统计学意义,需要进行更大的研究来证实这一点。