Trial results for a study evaluating the safety of Infliximab Biosimilar 3 in people with Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis were posted on ClinicalTrials.gov on 2025-06-04, with a total enrollment of 2207 participants.

Background

Rheumatoid Arthritis (RA) is a chronic autoimmune disease characterized by inflammation, pain, and swelling, primarily affecting the joints. Other conditions included in this study, such as Ulcerative Colitis, Crohn's Disease, and Psoriasis, are also inflammatory disorders. Infliximab, marketed as Remicade, is a widely used biologic therapy for these conditions. The development of biosimilar versions of established biologics aims to provide alternative treatment options that are potentially more accessible and affordable, while maintaining comparable efficacy and safety profiles to their reference products. This study was conducted to assess the safety profile of an infliximab biosimilar.

Trial design

The completed study, titled "A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis," enrolled a total of 2207 participants. The trial included patients diagnosed with Arthritis, Rheumatoid, Colitis, Ulcerative, Crohn Disease, and Psoriasis. The primary objective of the study was to learn about the safety of the investigational medicine, Infliximab Biosimilar 3 (Infliximab BS for I.V. Infusion 100mg [Pfizer] [Infliximab Biosimilar3]), in comparison to the reference product, Remicade (Infliximab [Genetical Recombination]). The study's phase was not specified in the provided data.

Key results

The trial results included incidence rates for serious infections and tuberculosis, along with comparative analyses between the biosimilar and the reference product.

Regarding the incidence rate of tuberculosis (per 1 person-year), both Infliximab Biosimilar 3 and Remicade reported an incidence rate of 0.00 across all measurements.

Comparative analyses were also provided:

What this means

The posted safety data for Infliximab Biosimilar 3, evaluated in a large cohort of 2207 participants with rheumatoid arthritis, ulcerative colitis, Crohn's disease, or psoriasis, offers insights into its safety profile relative to Remicade. The incidence rates for serious infections varied, with some measurements showing the biosimilar at 0.06 compared to Remicade's 0.09, while others showed the biosimilar at 0.22 versus Remicade's 0.09 or 0.13 versus 0.09. The comparative analyses, including Cox Proportional Hazard and Risk Ratio, generally presented values above 1, suggesting a potentially higher risk for the biosimilar in some comparisons. However, the wide 95.0% confidence intervals, such as 0.39 to 5.2 for Cox Proportional Hazard and 0.38 to 5.34 for Risk Ratio, indicate considerable overlap and variability, making definitive conclusions about statistical significance challenging without additional statistical measures like p-values. Notably, no cases of tuberculosis (0.00) were reported for either treatment group. These findings contribute to the overall understanding of the safety profile of this infliximab biosimilar, which is crucial for informing treatment decisions for clinicians and patients.

Source

The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05796245, titled "A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis", were posted on 2025-06-04 on clinicaltrials.gov.