In the absence of head-to-head trials, what do real world studies tell us about the comparative effectiveness of biologics in Crohn's disease

Joseph Meserve, M. Barsky, Parambir S. Dulai*

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

2 Scopus citations

Abstract

Head-to-head clinical trials are the highest quality of evidence to support comparative effectiveness. However, there are currently no head-to-head phase 3 clinical trials of biologics in Crohn's Disease. With a need for direct comparisons but lagging RCTs, Real World Data (RWD) can provide evidence on the comparative effectiveness of biologics for a diverse population that is more generalizable to routine practice. The majority of available real-world comparative analyses show no significant difference in effectiveness outcomes-primarily clinical remission and CD related complications. Real-world data is limited by its susceptibility to bias and clinicians must critically evaluate the methods and data sources utilized. Moving forward, it is important to note that comparisons including newer biologics may be limited by significant prior biologic exposure. Additionally, shared decision making incorporates efficacy, safety, and tolerability with patient preference and clinicians should use data from real-world comparative analyses as a part of this equation.

Original languageEnglish (US)
Article number101619
JournalBest Practice and Research: Clinical Gastroenterology
Volume38-39
DOIs
StatePublished - Feb 1 2019
Externally publishedYes

Keywords

  • Comparative effectiveness
  • Crohn's disease
  • Real-world data
  • Real-world evidence

ASJC Scopus subject areas

  • Gastroenterology

Fingerprint

Dive into the research topics of 'In the absence of head-to-head trials, what do real world studies tell us about the comparative effectiveness of biologics in Crohn's disease'. Together they form a unique fingerprint.

Cite this