Pharmacokinetic, safety, and efficacy findings for patients with inflammatory bowel disease (IBD) were presented at the European Crohn's and Colitis Organization's annual meeting.
Analyses of multiple switches between biosimilars and originator forms of infliximab were presented at the European Crohn’s and Colitis Organization annual meeting (ECCO’21).
Switching Between Remicade and Biosimilars
Patients with inflammatory bowel disease (IBD) who switched multiple times between biosimilar forms of infliximab and the originator product (Remicade) demonstrated no unusual patterns in efficacy, safety, or immunogenicity, investigators reported at ECCO’21.1
Investigators sought to elucidate outcomes of significance among patients who switched from biosimilars to the reference product and switched multiple times between biosimilars. “As the access to biosimilars at competitive prices increases, it is necessary to evaluate multiple switches to provide data on their interchangeability,” they wrote.
In this retrospective cohort study (N = 26), investigators evaluated clinical disease activity, biochemical markers, infliximab trough (lowest concentration) levels, and anti-infliximab antibody levels both before and after switching.
The study enrolled patients with Crohn disease (n = 22) and ulcerative colitis (n = 4). Most patients were between 17 and 42 years of age, had ileocolonic disease, and an inflammatory phenotype (nonstricturing/nonpenetrating, structuring, or penetrating). Investigators said 44% of patients had perianal disease and half had pancolitis.
They said 51% of patients had prior resection surgery and 27% were on combination therapy when they first switched among infliximab products. Nine patients (35%) switched 3 times.
Investigators said there was no significant difference in the percentage of patients in clinical remission and no significant differences in laboratory markers such as C-reactive protein (an inflammation marker), hemoglobin (anemia marker), or albumin (protein deficiency marker) were noted before or after multiswitching.
Mean drug trough levels were not significantly different and no patients developed antidrug antibodies, had infusion-related adverse events, or lost response leading to drug discontinuation. Investigators said drug persistence was 100%.
Switching Between Flixabi and Remsima
Investigators found that patients who switched from one infliximab biosimilar to another experienced an increase in drug trough levels following the switch, although there was no effect on clinical and biochemical disease activity.2
In a poster presentation at ECCO’21, researchers concluded that switching infliximab biosimilars in IBD “appears safe in the short term with respect to maintaining drug pharmacokinetic (PK) profile and disease control whether switching for the first or second time.”
The advent of anti–tumor necrosis factor (TNF) biosimilars, which reduce inflammation, has enabled switching from originator products and cost savings in IBD without loss of disease control. In this study, investigators set out to understand the significance of a switch between biosimilars.
They reported on a prospective study (N = 221) of patients who switched from Remsima to Flixabi, both infliximab biosimilars, produced by Celltrion and Samsung Bioepis, respectively. Outcomes were compared for patients who switched up to 2 times.
Patients were stable on infliximab at baseline, and 79% (n = 174) were on concomitant immunomodulators. Investigators said roughly half of patients (n = 112) had a PK analysis done before and after switching.
Investigators observed a baseline median trough level of 4.5 µg/mL (2.9-6.3) prior to switching and 5.1 µg/mL (3.4-7.0; P = .02) post-switching.
Clinical scores, including for C-reactive protein, trough infliximab levels, and clinical disease activity, were similar before and after switching, and no new anti-infliximab antibodies were observed.
Investigators said 107 patients (48%) switched infliximab biosimilars for the second time, and of those, PK analysis was performed for 51. Investigators said the post-switch increase in median drug trough levels was similar between patients who switched for the first (4.7 vs 6.1 µg/mL, P = .03) and second (4.0 vs 4.5 µg/ml, P = .05) times.
They said there was no change in clinical disease activity or C-reactive protein in either group. Further, the use of concomitant immunomodulators and patient disease classification had no bearing on changes in infliximab levels, although these findings were not statistically significant (P = .72 and P = .37, respectively).
1. Nascimento C, Revés J, Morão B, et al. Outcomes of multiswitching from original infliximab to biosimilars in patients with inflammatory bowel disease. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster P555.
2. Luber R, O’Neill R, Singh S, Arkir Z, Irving P. Switching infliximab biosimilar: no adverse impact on inflammatory bowel disease control or drug levels with the first or second switch. Presented at: ECCO’21 Congress; July 2-3 and 8-10, 2021. Poster P485.