All children with inflammatory bowel disease (IBD) who were receiving maintenance infliximab at a single center between 2017 and 2018 were included in the study.
Evidence of the safety and efficacy of biosimilar infliximab CT-P13 continues to accrue, but most data on the use of the biosimilar in inflammatory bowel disease (IBD) derives from adult patients. One recent study evaluated long-term infliximab trough levels, immunogenicity, and remission rates in children with IBD who switched from the reference infliximab to biosimilar CT-P13.
All children with Crohn disease (CD) or ulcerative colitis (UC) who were receiving maintenance infliximab at a single center (which undertook a switch from reference to infliximab for all indications) between 2017 and 2018 were included in the study.
A total of 42 patients, 26 with CD and 16 with UC, were eligible for the study. They had a median duration on infliximab of 13.5 months (range, 6.8-35.5).
No significant changes in infliximab trough level occurred after the switch; the median baseline infliximab trough level was 5.7 μg/mL (range, 3.8-9.3) versus 6.5 μg/mL (range, 3.9-8.6) 6 months after the switch to the biosimilar (P = .90). The cumulative infliximab dose administered over 6 months was not significantly different before and after the switch, and 1 patient developed new antibodies to infliximab. The proportion of patients in clinical or biological remission did not significantly change, either.
No significant changes were observed in C-reactive protein, erythrocyte sedimentation rate, albumin, weight, or body mass index after the switch, and no new safety signals were observed.
Pediatric patients who receive infliximab can be successfully switched during maintenance therapy without impacting efficacy, safety, immunogenicity, or pharmacokinetics, the authors concluded.
These are welcome data that build on the limited available knowledge about using biosimilar infliximab in children with IBD. One recent review of the literature found that, in pediatric patients who started on reference or biosimilar infliximab, remission rates were similar, and no unexpected adverse events were noted.2
The review also noted similar remission rates for children who were new starts in Polish and UK studies, and reported that in Polish and Korean switching studies, respectively, disease exacerbation was not reported, and sustained remission was similar between those who switched and those who remained on reference infliximab.
Reference
1. van Hoeve K, Dreesen E, Hoffman I, Ferrante M, Ann G, Vermeire S. Swtiching from infliximab originator to a biosimilar does not affect pharmacokinetics, immunogenicity and efficacy in pediatric patients with inflammatory bowel disease. Presented at: Digestive Disease Week 2019, San Diego, California, May 18-21, 2019. Abstract 879.
2. Sieczkowska-Golub J, Jarzebicka D, Oracz G, Kierkus J. Biosimilars in paediatric inflammatory bowel disease. World J Gastroenterol. 2018;24(35):4021-4027. doi: 10.3748/wjg.v24.i35.4021.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Real-World Study: No Increase in Health Resource Costs After Infliximab Biosimilar Introduction
July 20th 2024Although biosimilars reduce drug purchasing costs for hospitals, it’s unclear whether those savings might be offset by increased health resource utilization following a non-medical switching initiative.
Biosimilars Gastroenterology Roundup for May 2024—Podcast Edition
June 2nd 2024On this episode of Not So Different, we review the biggest gastroenterology biosimilar stories from May 2024, covering new data from conferences and journals on infliximab and adalimumab products that demonstrate positive clinical results and confirm the safety of these biosimilars, as well as the feasibility of switching to them.
Trastuzumab-dkst Shows Promising Results in Real-World Setting for HER2+ Breast Cancer
July 9th 2024A Brazilian real-world study found trastuzumab-dkst to be an effective and safe adjuvant therapy for HER2-positive (HER2+) breast cancer, with clinical outcomes comparable to reference trastuzumab.