Comparative Safety Analysis of Infliximab with Its Biosimilar Infliximab-dyyb in Pediatric Rheumatic Conditions

2020 Year in Review - Biosimilars —January 13, 2021



Preliminary real-world retrospective data indicate comparable safety profiles for infliximab-dyyb and infliximab in pediatric rheumatic conditions.

The safety and efficacy of infliximab and its biosimilar are well-studied in adult patients with rheumatoid arthritis and ankylosing spondylitis; however, comprehensive safety analysis in the pediatric population is limited. At the American College of Rheumatology 2020 Pediatric Rheumatology Symposium, the findings of a retrospective chart review comparing the safety of infliximab-dyyb with reference infliximab, as well as cost-savings with biosimilar use in pediatric rheumatic conditions, were scheduled for presentation.

This retrospective chart review identified patients prescribed infliximab or infliximab-dyyb for various rheumatic conditions, including juvenile idiopathic arthritis (JIA), chronic uveitis, or Behçet’s disease at a quaternary pediatric hospital between March 1, 2017, and August 30, 2019. The primary study objective was to compare side effects and time to discontinuation; the secondary study objective was to assess cost-savings with use of infliximab-dyyb compared with infliximab.

A total of 33 patients who received infliximab or infliximab-dyyb were included in the analysis; of these, 16 patients received infliximab-dyyb and 17 patients received reference infliximab. The mean age of the study population was 17 years (range, 7-26 years); the majority of patients were female (62%) and had a primary diagnosis of JIA (85%). A similar proportion of patients discontinued reference or biosimilar therapy, with 6 patients discontinuing infliximab-dyyb and 7 discontinuing infliximab therapy; average time to therapy discontinuation was 178 days (standard deviation [SD], ±188.5) and 213 days (SD, ±240) for infliximab-dyyb and infliximab, respectively. The reasons for discontinuation were similar between groups.

The side-effect profiles were similar between the infliximab-dyyb and infliximab groups (18.8% vs 13.3%, respectively). A higher proportion of patients indicated a preference for infliximab-dyyb over infliximab and showed intolerance to infliximab-dyyb. Compared with infliximab, the average cost-savings per infusion of infliximab-dyyb was $970.

The findings of this preliminary retrospective data indicate comparable safety profiles for infliximab-dyyb and infliximab in pediatric rheumatic conditions when utilized in the real-world setting.

Culp M, et al. Arthritis Rheumatol. 2020;72(suppl 10):Abstract 42.


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Last modified: January 13, 2021

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