Dipasquale Valeria, Pellegrino Salvatore, Ventimiglia Marco, Citrano Michele, Graziano Francesco, Cappello Maria, Busacca Anita, Orlando Ambrogio, Accomando Salvatore, Romano Claudio
Pediatric Gastroenterology and Cystic Fibrosis Unit, Department of Human Pathology in Adulthood and Childhood "G. Barresi", University Hospital "G. Martino", 98100 Messina, Italy.
Directorate General of Medical Device and Pharmaceutical Service, Italian Ministry of Health, 00153 Rome, Italy.
Healthcare (Basel). 2024 Feb 4;12(3):404. doi: 10.3390/healthcare12030404.
The utilization of anti-tumor necrosis factor-α (anti-TNF-α) biosimilars in inflammatory bowel disease (IBD) is constantly increasing. However, pediatric data are limited. This study aimed to assess the effectiveness and safety of adalimumab biosimilar (ADL-BioS) in pediatric IBD patients.
All consecutive pediatric IBD patients from the Sicilian Network for Inflammatory Bowel Disease cohort treated with ADL-BioS from 2019 to 2021 were recruited. Remission at weeks 14 and 52, treatment persistence, and adverse events were the endpoints of this study. Factors associated with clinical remission and treatment persistence were examined.
There were 41 patients in total. Nine (22%) patients were switched from the reference product to ADL-BioS. Two patients had multiple switches. Eleven months was the median follow-up period. Clinical remission was attained by 70.7% and 72.0% of patients on weeks 14 and 52, respectively. Four (9.8%) adverse events occurred (10.1/100 person-year). Treatment persistence was 85.4% at 1 and 2 years. Patients with a longer duration of disease had a higher probability of stopping their treatment ( = 0.036).
This is the first real-world study that particularly addresses the use of ADL-BioS in pediatric IBD. With high rates of treatment persistence and a low frequency of non-serious side effects, ADL-BioS seems to be effective.
抗肿瘤坏死因子-α（抗TNF-α）生物类似药在炎症性肠病（IBD）中的应用正在不断增加。然而，儿科数据有限。本研究旨在评估阿达木单抗生物类似药（ADL-BioS）在儿科IBD患者中的有效性和安全性。
招募了2019年至2021年期间西西里炎症性肠病网络队列中所有连续接受ADL-BioS治疗的儿科IBD患者。本研究的终点为第14周和第52周的缓解情况、治疗持续性和不良事件。研究了与临床缓解和治疗持续性相关的因素。
共有41例患者。9例（22%）患者从参比产品换用ADL-BioS。2例患者有多次换药。中位随访期为11个月。第14周和第52周分别有70.7%和72.0%的患者实现临床缓解。发生了4例（9.8%）不良事件（10.1/100人年）。1年和2年时的治疗持续性为85.4%。病程较长的患者停药概率更高（P = 0.036）。
这是第一项特别针对ADL-BioS在儿科IBD中应用的真实世界研究。ADL-BioS似乎有效，治疗持续性高且非严重副作用发生率低。
