Safety of Rapid Infliximab Biosimilar Infusions in Patients With Inflammatory Bowel Disease

Abstract

Background The biosimilar landscape for inflammatory bowel disease (IBD) continues to grow, with several biosimilar products for originator infliximab now available. The rapid infusion of originator infliximab and infliximab-dyyb has been shown to be well tolerated; however, the tolerability of rapid infusion in patients receiving infliximab-abda, another infliximab biosimilar, or in those who have switched among originator infliximab and biosimilars remains unknown. Objective We aimed to evaluate the safety of rapid infusion in patients with IBD who received infliximab-abda or underwent switches with infliximab products. Methods We conducted a retrospective observational study of all infliximab-related infusion encounters for patients ≥18 years with IBD who received their infusion over 30 to 90 minutes at our institution between March 1, 2020, and September 30, 2020. Patient, disease, and treatment characteristics were collected. The primary outcome was infusion reactions. Results A total of 377 infusion encounters for 96 unique patients were evaluated. Within the study cohort, 16% of patients were treated with originator infliximab, 42% with infliximab-dyyb, and 2% with infliximab-abda. The remaining 41% of patients received at least 2 infliximab products during the study period, primarily infliximab-dyyb and infliximab-abda. Approximately 54% and 42% of infusions encounters included premedication and immunomodulator use. Within the 377 infusion encounters, no infusion reactions were noted. Conclusion and Relevance Rapid infusion of infliximab biosimilars (including infliximab-abda) and in patients who have switched among originator infliximab and biosimilars is well tolerated. Future studies should assess clinical impact and outcomes of rapid infusion with biosimilars.

Rapid infusion of infliximab biosimilars and the incidence and severity of infusion‐related reactions in patients with inflammatory bowel disease

“…There was low utilization of immunomodulator use in our patient population. This is a key difference from other literature evaluating rapid infusions of infliximab biosimilars, in which 21% and 19% of patients were on mercaptopurine and methotrexate, respectively 10 . There are data to suggest that combination therapy with an immunomodulator and anti‐TNF therapy reduces the risk of antibody formation, also known as immunogenicity 14 .…”

“…Another unique parameter, compared with similar literature, that was collected in this study was infliximab trough and antibody levels 10 . Therapeutic drug monitoring can be used to assess response and efficacy of infliximab, as well as immunogenicity 15 .…”

“…9 The safety of rapid infusions for infliximab biosimilar agents is largely unknown, and further assessment of rapid infliximab biosimilar infusions is needed to determine the safety of this practice. 5,10 The purpose of this study was to evaluate the incidence and severity of infusion reactions among patients with IBD receiving rapid infusion of infliximab reference product compared with infliximab biosimilar. Secondarily, we sought to further evaluate the incidence and severity of infusion reactions in patients receiving standard infusion infliximab and infliximab biosimilars, as well as rapid and standard infusion of infliximab biosimilars.…”

“…Increased use of biosimilar infliximab provides potential cost‐savings for institutions as well 9 . The safety of rapid infusions for infliximab biosimilar agents is largely unknown, and further assessment of rapid infliximab biosimilar infusions is needed to determine the safety of this practice 5,10 …”

“… 9 The safety of rapid infusions for infliximab biosimilar agents is largely unknown, and further assessment of rapid infliximab biosimilar infusions is needed to determine the safety of this practice. 5 , 10 …”