生物制剂治疗幼年特发性关节炎早期反应轨迹的潜在类别：四项试验分析。
Latent classes of early response trajectories to biologics initiation in juvenile idiopathic arthritis: an analysis of four trials.
机构信息
Department of Pediatrics, Children's Hospital Research Institute of Manitoba, University of Manitoba, 501F-715 McDermot Ave, Winnipeg, Manitoba, R3E 0V9, Canada.
Department of Community Health Sciences, University of Manitoba, Winnipeg, Canada.
出版信息
Pediatr Rheumatol Online J. 2022 Jul 30;20(1):57. doi: 10.1186/s12969-022-00719-1.
AIMS
- To delineate latent classes of treatment response to biologics in juvenile idiopathic arthritis (JIA) patients in the first 16 weeks after initiation. 2) To identify predictors of early disease response.
METHODS
The study population was drawn from four biologics trials in polyarticular course JIA: Etanercept 2000, Abatacept 2008, TRial of Early Aggressive Therapy (TREAT) 2012 and Tocilizumab 2014. The outcome was active joint counts (AJC). Semiparametric latent class trajectory analysis was applied to identify latent classes of response to treatment; AJC was transformed for this modelling. We tested baseline disease and treatment characteristics for their abilities to predict class membership of response.
RESULTS
There were 480 participants, 74% females. At baseline, 26% were rheumatoid factor positive. 67% were on methotrexate at enrollment. Three latent class solution provided the best fit. Baseline AJC was the sole best predictor of class membership. Participants classified by their highest membership probabilities into high baseline AJC (> 30) and slow response (26.5%), low baseline AJC (< 10), early and sustained response (29.7%), and moderate baseline AJC progressive response (43.8%). Participants were classified into the latent classes with a mean class membership posterior probability of 0.97. Those on methotrexate at baseline were less likely to belong to high baseline AJC class.
CONCLUSIONS
Three latent classes of responses were detectable in the first 16 weeks of biologics therapy. Those with the highest baseline AJC demonstrated very slow response in this window and were less likely to be on concomitant methotrexate.
TRIALS REGISTRATION
TREAT 2012 (NCT NCT00443430 ) (Wallace et. al, Arthritis Rheum 64:2012-21, 2012), tocilizumab trial 2014 ( NCT00988221 ), abatacept trial 2008 ( NCT00095173 ). Etanercept 2000 from Amgen does not have a trial registration number.
目的
1）描绘生物制剂治疗幼年特发性关节炎（JIA）患者在起始后 16 周内的治疗反应的潜在类别。2）确定早期疾病反应的预测因素。
方法
该研究人群来自四项多关节病程 JIA 的生物制剂试验：依那西普 2000 年、阿巴西普 2008 年、早期积极治疗试验（TREAT）2012 年和托珠单抗 2014 年。结局是活跃关节计数（AJC）。采用半参数潜在类别轨迹分析来确定治疗反应的潜在类别；为了进行建模，对 AJC 进行了转换。我们测试了基线疾病和治疗特征，以确定其预测反应类别成员的能力。
结果
共有 480 名参与者，其中 74%为女性。基线时，26%的人类风湿因子阳性。67%的人在入组时接受甲氨蝶呤治疗。三种潜在类别解决方案提供了最佳拟合。基线 AJC 是类别成员资格的唯一最佳预测因子。根据其最高成员概率将参与者分为高基线 AJC（>30）和缓慢反应（26.5%）、低基线 AJC（<10）、早期和持续反应（29.7%）以及中度基线 AJC 进行性反应（43.8%）。参与者的平均类别成员后验概率为 0.97。基线时接受甲氨蝶呤治疗的参与者不太可能属于高基线 AJC 类别。
结论
在生物制剂治疗的前 16 周内，可以检测到三种反应的潜在类别。那些基线 AJC 最高的患者在这个时间窗口内反应非常缓慢，并且不太可能同时接受甲氨蝶呤治疗。
试验注册
TREAT 2012（NCT NCT00443430）（Wallace 等人，关节炎 Rheum 64:2012-21, 2012 年），托珠单抗试验 2014 年（NCT00988221 年），阿巴西普试验 2008 年（NCT00095173 年）。安进的依那西普 2000 年没有试验登记号。
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