Ancona Silvana, Armstrong Katherine, Longo Chiara, Rabone Rosalind, Merrick Victoria, Henderson Paul, Gandullia Paolo, Wilson David C, Arrigo Serena, Russell Richard K
Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health, University of Genoa, Genoa, Italy.
Department of Paediatric Gastroenterology and Nutrition, Royal Hospital for Children and Young People, Edinburgh, UK.
Biologics. 2025 Apr 29;19:265-279. doi: 10.2147/BTT.S511248. eCollection 2025.
Adalimumab biosimilars are increasingly used in paediatric Inflammatory Bowel Disease (PIBD), but data remain limited. This study assessed their durability, efficacy, safety and cost implications in PIBD.
Consecutive PIBD patients who started adalimumab biosimilars between October 2018 and December 2023 at two centres in Scotland and Italy, with at least 6 months follow-up, were included. Demographic, disease, treatment, and adverse event data were collected. Disease activity was assessed at baseline, 6, 12, 24, 36 months, and at last follow-up. Durability was evaluated using Kaplan-Meier analysis.
In total 130 patients (81 males; median age 12.3 years) were included (115 Crohn's Disease, 7 Ulcerative Colitis, 8 IBD unclassified). The biosimilars were ABP 501 (85%), GP2017 (14%), SB5 (1%); 41 (32%) patients switched from originator. After a median follow-up of 26 months, 87/130 (67%) patients remained on biosimilars, while 43 discontinued at a median of 14 months. Durability probabilities were 93%, 86%, 75%, 62%, and 57% at 6, 12, 24, 36, and 54 months, respectively. Patients previously exposed to ADA originator had a lower risk of biosimilar failure (hazard ratio, adjusted for age at diagnosis: 0.51 [95% confidence interval: 0.26-0.99], p=0.047). Trough levels ≥11.6 μg/mL at 6 months were associated with greater durability (. Adverse events occurred in 46/130 patients, mainly psoriasis and injection site reactions (13% each), with one lymphoma. Estimated cost savings were 5,030€ per patient/year.
This real-life study demonstrated high durability and remission rates for adalimumab biosimilars in PIBD, confirming their clinical, cost-effectiveness and safety profile in children.
阿达木单抗生物类似药在儿童炎症性肠病（PIBD）中的应用日益广泛，但相关数据仍然有限。本研究评估了其在PIBD中的持久性、疗效、安全性及成本影响。
纳入2018年10月至2023年12月期间在苏格兰和意大利的两个中心开始使用阿达木单抗生物类似药且随访至少6个月的连续性PIBD患者。收集人口统计学、疾病、治疗及不良事件数据。在基线、6、12、24、36个月及末次随访时评估疾病活动度。使用Kaplan-Meier分析评估持久性。
共纳入130例患者（81例男性；中位年龄12.3岁）（115例克罗恩病，7例溃疡性结肠炎，8例未分类的炎症性肠病）。生物类似药为ABP 501（85%）、GP2017（14%）、SB5（1%）；41例（32%）患者从原研药转换而来。中位随访26个月后，有87/130例（67%）患者仍在使用生物类似药，43例在中位时间14个月时停药。6、12、24、36和54个月时的持久性概率分别为93%、86%、75%、62%和57%。既往接触过阿达木单抗原研药的患者生物类似药失效风险较低（风险比，根据诊断时年龄调整：0.51[95%置信区间：0.26 - 0.99]，p = 0.047）。6个月时谷浓度≥11.6μg/mL与更高的持久性相关。46/130例患者发生不良事件，主要为银屑病和注射部位反应（各占13%），1例发生淋巴瘤。估计每位患者每年节省成本5030欧元。
这项真实世界研究证明了阿达木单抗生物类似药在PIBD中的高持久性和缓解率，证实了其在儿童中的临床、成本效益及安全性。
