Optimizing the Start Time of Biologics in Polyarticular Juvenile Idiopathic Arthritis: A Comparative Effectiveness Study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans.

Optimizing the Start Time of Biologics in Polyarticular Juvenile Idiopathic Arthritis: A Comparative Effectiveness Study of Childhood Arthritis and Rheumatology Research Alliance Consensus Treatment Plans.
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DOI:
10.1002/art.41888
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发表时间:
2021-10
期刊:
Arthritis & rheumatology (Hoboken, N.J.)
影响因子:
--
通讯作者:
CARRA STOP-JIA Investigators
CARRA STOP-JIA Investigators
中科院分区:
其他
文献类型:
--
作者:
Kimura Y;Schanberg LE;Tomlinson GA;Riordan ME;Dennos AC;Del Gaizo V;Murphy KL;Weiss PF;Natter MD;Feldman BM;Ringold S;CARRA STOP-JIA Investigators

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多关节型幼年特发性关节炎 (JIA) 开始使用生物制剂的最佳时间仍不确定。儿童关节炎和风湿病研究联盟 (CARRA) 针对未经治疗的多关节 JIA 制定了 3 个共识治疗计划 (CTP),以比较开始使用生物制剂的策略。多关节型 JIA 生物制剂的开始时间优化 (STOP-JIA) 是一项前瞻性、观察性 CARRA 注册研究,比较了 3 个 CTP 的有效性:1) 升级计划(初始非生物疾病缓解抗风湿药物 [DMARD] 单药治疗,如果需要添加生物制剂,2) 早期联合计划(DMARD 和生物制剂一起开始),3) 生物制剂优先计划(生物制剂单药治疗)。主要结局指标是根据美国风湿病学会 (ACR) 临时标准,12 个月时未使用糖皮质激素的临床非活动性疾病。次要结果指标包括患者报告结果测量信息系统 (PROMIS) 疼痛干扰和活动度评分、10 个关节临床幼年关节炎疾病活动评分 (JADAS-10) 定义的非活动性疾病,以及 ACR Pediatric 70 标准 (Pedi 70)。在入组的 400 名患者中,257 名 (64%) 名患者开始升级计划,100 名 (25%) 名患者开始早期联合计划,43 名 (11%) 名患者开始生物优先计划。经过倾向评分加权和多重插补后,早期联合计划中 37% 的患者、升级计划中的 32% 患者以及生物首个计划中的 24% 患者达到了根据 ACR 标准的临床非活动性疾病(P = 0.17)。根据临床 JADAS-10(评分≤2.5),早期联合计划中达到非活动性疾病的患者数量也多于升级计划(59% 对比 43%;P = 0.03),ACR Pedi 70 也是如此(81% 对比 62%;P = 0.008),但普遍性因缺失数据而受到限制。所有组的 PROMIS 测量值均有所改善,但没有显着差异。报告了二十起严重不良事件(主要是感染)。 12 个月时,在不使用糖皮质激素的情况下,各组之间的临床非活动性疾病的进展没有显着差异。虽然根据临床 JADAS-10 和 ACR Pedi 70,早期联合治疗实现非活动性疾病的可能性明显更高,但这些结果需要进一步探索。
The optimal time to start biologics in polyarticular juvenile idiopathic arthritis (JIA) remains uncertain. The Childhood Arthritis and Rheumatology Research Alliance (CARRA) developed 3 consensus treatment plans (CTPs) for untreated polyarticular JIA to compare strategies for starting biologics. Start Time Optimization of Biologics in Polyarticular JIA (STOP‐JIA) was a prospective, observational, CARRA Registry study comparing the effectiveness of 3 CTPs: 1) the step‐up plan (initial nonbiologic disease‐modifying antirheumatic drug [DMARD] monotherapy, adding a biologic if needed, 2) the early combination plan (DMARD and biologic started together), and 3) the biologic first plan (biologic monotherapy). The primary outcome measure was clinically inactive disease according to the provisional American College of Rheumatology (ACR) criteria, without glucocorticoids, at 12 months. Secondary outcome measures included Patient‐Reported Outcomes Measurement Information System (PROMIS) pain interference and mobility scores, inactive disease as defined by the clinical Juvenile Arthritis Disease Activity Score in 10 joints (JADAS‐10), and the ACR Pediatric 70 criteria (Pedi 70). Of 400 patients enrolled, 257 (64%) began the step‐up plan, 100 (25%) the early combination plan, and 43 (11%) the biologic first plan. After propensity score weighting and multiple imputation, clinically inactive disease according to the ACR criteria was achieved in 37% of those on the early combination plan, 32% on the step‐up plan, and 24% on the biologic first plan (P = 0.17). Inactive disease according to the clinical JADAS‐10 (score ≤2.5) was also achieved in more patients on the early combination plan than the step‐up plan (59% versus 43%; P = 0.03), as was ACR Pedi 70 (81% versus 62%; P = 0.008), but generalizability was limited by missing data. PROMIS measures improved in all groups, but without significant differences. Twenty serious adverse events were reported (mostly infections). Achievement of clinically inactive disease without glucocorticoids did not significantly differ between groups at 12 months. While there was a significantly higher likelihood of early combination therapy achieving inactive disease according to the clinical JADAS‐10 and ACR Pedi 70, these results require further exploration.
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