why choose us

300×250 Ad Slot

Research Article: Adalimumab Biosimilar in Pediatric Inflammatory Bowel Disease: A Retrospective Study from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

Date Published: 2024-02-04

Abstract:
Background: The utilization of anti-tumor necrosis factor-? (anti-TNF-?) 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. Methods: 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. Results: 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 (p = 0.036). Conclusions: 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.

Introduction:
Tumor necrosis factor-? (TNF-?) inhibitors were the first biologic drugs approved for the treatment of inflammatory bowel disease (IBD). Adalimumab (ADL) (Humira®) is a fully humanized IgG1 monoclonal antibody with a high affinity for TNF-? and was introduced as the second TNF-? inhibitor after infliximab (IFX) (Remicade®) [1]. The high cost of TNF-? inhibitors is one of their major drawbacks [2]. The product patent for ADL expired in Europe in October 2018, resulting in the development of a robust pipeline of…

Read more

300×250 Ad Slot