Background and Aims Most pediatric IBD studies are performed after medications are approved in adults and the majority of participants in these studies are adolescents. We hypothesized that adolescent-onset IBD is not fundamentally different than adult-onset IBD. If this is correct, the value of delaying access to novel drugs in adolescents becomes questioned. Methods Data from 11 randomized, double-blind, placebo-controlled adult phase 2 and 3 trials of 4 biologics were analyzed. Participants were categorized as having adolescent- or adult-onset disease (diagnosed 12 to <18, or ≥18 years). Multivariable modelling explored the association between age at diagnosis and response to treatment after adjustment for disease duration, extent, and severity at baseline. Data from dose arms were pooled to evaluate similarity of therapeutic response between adolescent- and adult-onset IBD within the same trial (not between doses or across trials). Ratios of odds ratios between the two groups were evaluated. Results Data from 6,283 study participants (2,575 with Crohn’s disease [CD], 3,708 with ulcerative colitis [UC]) were evaluated. Of 2,575 study participants with CD, 325 were 12-<18 years old at diagnosis; 836 participants (32.4%) received placebo. Of 3,708 participants with UC, 221 were 12-<18 years old at diagnosis; 1,212 (33%) were receiving placebo. The majority of the ratios of ORs were within two-fold, suggesting that responses in adolescent and adult-onset participants are generally similar. Conclusion Data presented lend support for extrapolating efficacy of biologics from adults to adolescents with IBD, which would facilitate earlier labeling and patient access.

中文翻译：

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成人炎症性肠病临床试验的结果：评估青少年发病和成人发病的疾病参与者的相似性

背景和目的 大多数儿童 IBD 研究是在成人药物获得批准后进行的，这些研究的大多数参与者是青少年。我们假设青少年发病的 IBD 与成人发病的 IBD 没有根本不同。如果这是正确的，那么延迟青少年获得新药的价值就会受到质疑。方法 对 4 种生物制剂的 11 项随机、双盲、安慰剂对照成人 2 期和 3 期试验的数据进行了分析。参与者被分类为患有青少年或成人发病的疾病（诊断年龄为12至<18岁，或≥18岁）。多变量模型探讨了在调整基线疾病持续时间、范围和严重程度后诊断年龄与治疗反应之间的关联。汇总来自剂量组的数据，以评估同一试验内（而不是剂量之间或试验间）青少年和成人发病的 IBD 之间治疗反应的相似性。评估两组之间的比值比。结果 对 6,283 名研究参与者（2,575 名患有克罗恩病 [CD]，3,708 名患有溃疡性结肠炎 [UC]）的数据进行了评估。在 2,575 名患有 CD 的研究参与者中，325 名诊断时年龄为 12-<18 岁；836 名参与者 (32.4%) 接受了安慰剂。在 3,708 名 UC 参与者中，221 名诊断时年龄为 12-<18 岁；1,212 人（33%）正在接受安慰剂。大多数 OR 比率在两倍以内，表明青少年和成人发病参与者的反应通常相似。结论 所提供的数据支持推断生物制剂从成人到青少年 IBD 的疗效，这将有助于更早的标签和患者获取。