Multiple infliximab biosimilar switches appear to be safe and effective in a real‐world inflammatory bowel disease cohort

Abstract

Background Switching from originator infliximab (IFX) to biosimilar IFX is effective and safe. However, data on multiple switching are scarce. The Edinburgh inflammatory bowel disease (IBD) unit has undertaken three switch programmes: (1) Remicade to CT‐P13 (2016), (2) CT‐P13 to SB2 (2020), and (3) SB2 to CT‐P13 (2021). Objective The primary endpoint of this study was to assess CT‐P13 persistence following switch from SB2. Secondary endpoints included persistence stratified by the number of biosimilar switches (single, double and triple), effectiveness and safety. Methods We performed a prospective, observational, cohort study. All adult IBD patients on IFX biosimilar SB2 underwent an elective switch to CT‐P13. Patients were reviewed in a virtual biologic clinic with protocol driven collection of clinical disease activity, C‐reactive protein (CRP), faecal calprotectin (FC), IFX trough/antibody levels, and drug survival. Results 297 patients (CD n = 196 [66%], ulcerative colitis/inflammatory bowel disease unclassified n = 101, [34%]) were switched (followed‐up: 7.5 months [6.8–8.1]). This was the third, second and first IFX switch for 67/297 (22.5%), 138/297 (46.5%) and 92/297 (31%) of the cohort respectively. 90.6% of patients remained on IFX during follow‐up. The number of switches was not independently associated with IFX persistence after adjusting for confounders. Clinical (p = 0.77), biochemical (CRP ≤5 mg/ml; p = 0.75) and faecal biomarker (FC<250 µg/g; p = 0.63) remission were comparable at baseline, week 12 and week 24. Conclusion Multiple successive switches from IFX originator to biosimilars are effective and safe in patients with IBD, irrespective of the number of IFX switches.

Practical Management of Biosimilar Use in Inflammatory Bowel Disease (IBD): A Global Survey and an International Delphi Consensus

“…Statement 6 relied on the concept of interchangeability. Interchangeability allows a biosimilar product to be replaced by the reference product [19,20], making multiple switches from one biosimilar to another feasible in cases of drug unavailability [21][22][23].…”

Additional Data in Expanded Patient Populations and New Indications Support the Practice of Biosimilar-to-Biosimilar Switching

“…In a prospective observational cohort study, a total of 297 patients with IBD (CD, n = 196 [66%]; UC/IBD unclassified, n = 101 [34%]) were switched from infliximab biosimilar SB2 to infliximab biosimilar CT‐P13 [ 13 ]. During the follow-up period, 9.4% of patients discontinued infliximab treatment.…”

Anti-inflammatory activity of plant sterols in a co-culture model of intestinal inflammation: focus on food-matrix effect

“…Inflammatory bowel diseases are a group of pathologies characterised by an excessive inflammatory response in the gastrointestinal tract. 32 Two main clinical phenotypes stand out, ulcerative colitis and Chron's disease. Due to the growing prevalence of these diseases, 33 it is of great interest to identify new possible alternatives to conventional treatments, such as dietary bioactive compounds.…”