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New biologic agents: a critical appraisal.

B E Sands1

  • 1Gastrointestinal Unit and Center for the Study of Inflammatory Bowel Disease, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, GRJ 825a, Boston, MA 02114, USA.

Current Gastroenterology Reports
|September 12, 2000
PubMed
Summary

Infliximab, approved in 1998, marked a significant advancement in Crohn's disease treatment. Its efficacy established a benchmark for future biologic therapies in inflammatory bowel disease management.

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Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Crohn's disease is a chronic inflammatory bowel disease.
  • Biologic therapies represent a new class of treatments.
  • Recombinant and monoclonal technologies have advanced biologic agent production.

Purpose of the Study:

  • To review the landmark approval of infliximab for Crohn's disease.
  • To assess the impact of infliximab as a biologic response modifier.
  • To establish a benchmark for future biologic agents in inflammatory bowel disease.

Main Methods:

  • Review of clinical data available for infliximab.
  • Appraisal of the efficacy and potential of biologic agents.
  • Comparison of infliximab's performance against established therapeutic standards.

Main Results:

  • Infliximab's 1998 approval was a landmark in inflammatory bowel disease therapy.
  • It is the first of several biologic response modifiers developed recently.
  • Its notable efficacy serves as a benchmark for subsequent biologic agents.

Conclusions:

  • Sufficient clinical data exists for critical appraisal of infliximab.
  • The efficacy of infliximab sets a high standard for future therapies.
  • Further clinical trials will be necessary for direct comparisons of biologic agents.

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