Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
PRI Research, Bad Bramstedt, Germany.
Arthritis Care Res (Hoboken). 2023 Nov;75(11):2259-2266. doi: 10.1002/acr.25156. Epub 2023 Jun 22.
To investigate the frequency and trajectories of individual patients with polyarticular-course juvenile idiopathic arthritis (JIA) achieving novel composite end points on abatacept.
Data from a clinical trial of subcutaneous abatacept (NCT01844518) and a post hoc analysis of intravenous abatacept (NCT00095173) in patients with polyarticular-course JIA were included. Three end points were defined and evaluated: combined occurrence of low disease activity (LDA) measured by the Juvenile Arthritis Disease Activity Score; 50% improvement in American College of Rheumatology criteria for JIA (ACR50); and patient-reported outcomes. Patient-reported outcomes included visual analog scale score of minimal pain (pain-min) and Childhood Health Assessment Questionnaire disability index score of 0 (C-HAQ DI0). In this post hoc analysis, maintenance of month 13 and 21 end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) in those who achieved them at month 4 was determined.
Composite end points (LDA+pain-min, LDA+C-HAQ DI0, and ACR50+pain-min) were achieved at month 4 (44.7%, 19.6%, and 58.9% of the 219 patients treated with subcutaneous abatacept, respectively). Of those who achieved LDA+pain-min at month 4, 84.7% (83 of 98) and 65.3% (64 of 98) maintained LDA+pain-min at months 13 and 21, respectively. The proportions of patients meeting LDA+pain-min outcomes increased from 44.7% (98 of 219) at month 4 to 54.8% (120 of 219) at month 21. The frequency of patients who met an LDA+C-HAQ DI score of 0 increased from 19.6% (43 of 219) at month 4 to 28.8% (63 of 219) at month 21.
Among individual patients with polyarticular-course JIA treated with abatacept who achieved 1 of the combined clinical and patient-reported outcomes composite end points, many maintained them over 21 months of abatacept treatment.
研究接受阿巴西普治疗的多关节病程幼年特发性关节炎(JIA)患者达到新型复合终点的频率和轨迹。
纳入了皮下注射阿巴西普的临床试验(NCT01844518)和静脉注射阿巴西普的事后分析(NCT00095173)的数据,这些数据来自多关节病程 JIA 患者。定义并评估了三个终点:用幼年特发性关节炎疾病活动评分(JADAS)测量的低疾病活动度(LDA)的综合发生情况;美国风湿病学会对 JIA 的 50%改善标准(ACR50);以及患者报告的结果。患者报告的结果包括最小疼痛的视觉模拟评分(疼痛最小)和儿童健康评估问卷残疾指数评分 0(C-HAQ DI0)。在这项事后分析中,确定了在第 4 个月达到这些终点的患者在第 13 个月和第 21 个月维持这些终点(LDA+疼痛最小、LDA+C-HAQ DI0 和 ACR50+疼痛最小)的情况。
在接受皮下注射阿巴西普的 219 例患者中,分别有 44.7%(219 例中的 98 例)、19.6%(219 例中的 43 例)和 58.9%(219 例中的 120 例)在第 4 个月达到了复合终点(LDA+疼痛最小、LDA+C-HAQ DI0 和 ACR50+疼痛最小)。在第 4 个月达到 LDA+疼痛最小的患者中,分别有 84.7%(98 例中的 83 例)和 65.3%(98 例中的 64 例)在第 13 个月和第 21 个月维持了 LDA+疼痛最小的状态。达到 LDA+疼痛最小结果的患者比例从第 4 个月的 44.7%(219 例中的 98 例)增加到第 21 个月的 54.8%(219 例中的 120 例)。在第 4 个月达到 LDA+C-HAQ DI 评分 0 的患者比例从 19.6%(219 例中的 43 例)增加到第 21 个月的 28.8%(219 例中的 63 例)。
在接受阿巴西普治疗的多关节病程 JIA 患者中,达到 1 项联合临床和患者报告的终点复合终点的患者中,许多患者在接受阿巴西普治疗 21 个月后仍保持该终点。