Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study

Abstract

Purpose The aim was to compare outcomes in adult patients with inflammatory bowel disease (IBD) who switched to infliximab-dyyb with those who remained on reference product (RP) infliximab in the United States (US) in a retrospective, propensity score-matched, non-inferiority cohort trial. Methods This study was a retrospective, non-inferiority study conducted within a US integrated healthcare system and included adult patients with a confirmed diagnosis of Crohn's disease or ulcerative colitis. A 1:1 propensity score matching was utilized to match patients who switched to infliximab-dyyb during the period April 2016-March 2018 to patients who remained on RP infliximab. The non-inferiority margin was set at + 10% of the upper limit. The primary outcome was a composite measure of disease worsening requiring acute care after the index date of switching to infliximab-dyyb or continuing RP infliximab. Disease worsening requiring acute care was defined as any IBD-related emergency room visit, hospitalization, or surgery. The secondary outcome was the composite measure of disease worsening requiring acute care or treatment failure. A switch to another biologic or tofacitinib was a proxy for treatment failure. All patients were followed for up to 9 months. Results After propensity score matching, the matched cohort included 1409 patients in the infliximab-dyyb group and 1409 patients in the RP infliximab group. The overall mean age (± standard deviation) was 47.7 ± 17.0 years, 50.9% of patients were of male gender, and 51.8% of patients had Crohn's disease, while the remainder of the cohort had ulcerative colitis. There were 144 patients (10.2%) in the infliximab-dyyb group and 245 patients (17.4%) in the RP infliximab group who experienced disease worsening requiring acute care (P < 0.01 for non-inferiority). There were 347 patients (24.6%) in the infliximab-dyyb group who experienced disease worsening requiring acute care or treatment failure compared to 375 patients (26.6%) who remained on RP infliximab (P < 0.01 for non-inferiority). Conclusion There was no increased risk of (1) disease worsening requiring acute care or (2) disease worsening requiring acute care or treatment failure in patients with IBD who switched from RP infliximab to infliximab-dyyb when compared to patients who remained on RP infliximab in this US population. Infliximab-dyyb is an option for patients with IBD who need to use RP infliximab.

Switching and Discontinuation Patterns Among Patients Stable on Originator Infliximab Who Switched to an Infliximab Biosimilar or Remained on Originator Infliximab

“…Abbreviations: CI, confidence interval; HR, hazard ratio; KM, Kaplan-Meier. Biologics: Targets and Therapy 2021:15 submit your manuscript | www.dovepress.comDovePress 6%, p<0.01),26 corroborating the current findings.…”

The Automatic Substitution of Biosimilars: Definitions of Interchangeability are not Interchangeable

“…If no other option exists, then such patients may need to be closely monitored and/or educated to maximize the likelihood of treatment persistence with the biosimilar. Indeed, mitigation measures, such as patient education, selection (e.g., based on disease stability and willingness to switch), and follow-up, have been associated with improved outcomes following switching for non-medical reasons [53,[64][65][66].…”

Infliximab switching from reference product to biosimilar: a review of evidence regarding the clinical efficacy, safety profile and immunogenicity

“…Of the 10 RCTs, one was a phase I and one was a phase IV trial, four were phase III trials, and three were open‐label extension (OLE) studies 8,13,15,16,20‐24,39 . The 13 observational studies comprised eight prospective observational cohorts, three retrospective observational cohorts and two mixed prospective and retrospective observational cohort studies 18,25–36 . Articles enrolled patients with the following clinical conditions: IBD (two RCTs, one RCT‐OLE, 10 observational studies), RA (five RCTs, two RCT‐OLEs, two observational studies), AS (one RCT, one RCT‐OLE, two observational studies), and PsA (one RCT, one RCT‐OLE, two observational studies).…”

“…In the study by Ho et al ., 35 1409 IBD patients who switched from the RP to biosimilar were matched with 1409 IBD patients who remained on RP. In the 9‐month follow up period, comparable proportions of patients in both groups experienced worsening of the disease that required acute care, or failure of the treatment or worsening of the disease that needed acute care.…”