Clinical use of biologics for Crohn's disease in adults: lessons learned from real-world studies

Expert Opin Biol Ther. 2024 Mar;24(3):171-189. doi: 10.1080/14712598.2024.2316180. Epub 2024 Feb 23.

Abstract

Introduction: The therapeutic armamentarium for managing Crohn's disease (CD) has expanded significantly in recent decades. Several biologics with three different mechanisms of action [anti-tumor necrosis factor (TNF)-α, anti-integrin α4β7, and anti-IL 12/23] are currently available to manage CD.

Area covered: This narrative review aims to summarize the most significant efficacy and safety data on the use of infliximab (IFX), adalimumab (ADA), vedolizumab (VDZ) and ustekinumab (UST) for the treatment of CD obtained from studies conducted in the real world (RW), compared to the results of randomized clinical trials (RCTs).

Expert opinion: RW studies reported that biologic agents included in this analysis have higher remission rates and lower adverse event rates than findings from RCTs for treating patients with CD. All biological agents have proven effective and safe in RW studies, even when using biosimilars or switching to subcutaneous administration of the molecules for which they are available. Finally, anti-TNF-α agents, particularly IFX, have a higher rate of adverse events (AEs) than VDZ and UST. Therefore, patients at higher risk of AEs may benefit from other biologics than anti-TNF-α. However, further long-term RW studies are needed to confirm these findings.

Keywords: Crohn’s disease; anti-TNF-α; efficacy; safety; ustekinumab; vedolizumab.

Publication types

  • Review

MeSH terms

  • Adalimumab / adverse effects
  • Adult
  • Biological Products* / adverse effects
  • Crohn Disease* / drug therapy
  • Humans
  • Infliximab / adverse effects
  • Retrospective Studies
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / therapeutic use
  • Ustekinumab / adverse effects

Substances

  • Biological Products
  • Adalimumab
  • Infliximab
  • Tumor Necrosis Factor-alpha
  • Ustekinumab