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Oral Small-Molecule Therapies Versus Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Systematic Review of

Okasha Zulfiqar1, Talha Ali2, Ghulam Mohayy Ud Din1

  • 1Internal Medicine, Mayo Hospital, Lahore, PAK.

Cureus
|June 25, 2026
PubMed

Insights

Oral small-molecule therapies show efficacy comparable to biologics for moderate-to-severe ulcerative colitis (UC). This review highlights their practical benefits and the importance of personalized, mechanism-based treatment selection for UC management.

Area of Science:

  • Gastroenterology
  • Immunology
  • Pharmacology

Background:

  • Ulcerative colitis (UC) management requires effective therapies for moderate-to-severe disease.
  • Biologic agents are established treatments, but oral small-molecule therapies are emerging.
  • Comparative efficacy and safety data are crucial for treatment selection.

Purpose of the Study:

  • To systematically review and compare the efficacy and safety of oral small-molecule therapies versus biologic agents in adults with moderate-to-severe UC.
  • To synthesize evidence from pivotal Phase 3 randomized controlled trials.
  • To assess induction and maintenance outcomes across different therapeutic mechanisms.

Main Methods:

  • Systematic review of eight landmark publications.
  • Inclusion of multiple pivotal Phase 3 randomized controlled trials.
  • Synthesis of data on induction and maintenance outcomes for various therapeutic mechanisms (cytokine signaling inhibition, immune trafficking modulation, extracellular pathway blockade).

Main Results:

  • Oral small-molecule therapies demonstrate clinically meaningful efficacy comparable to biologic agents.
  • Oral therapies offer advantages in administration and mechanistic diversity.
  • Distinct differences in induction and maintenance performance exist across therapeutic classes.

Conclusions:

  • Oral small-molecule therapies are integral to modern UC management.
  • Goal-directed therapy, risk stratification, and mechanism-based sequencing are vital.
  • Balancing efficacy, safety, and patient priorities is essential for optimal UC treatment.
Keywords:
biologicsinduction and maintenance therapyrandomized controlled trialssmall-molecule therapiessphingosine-1-phosphate receptor modulatorsulcerative colitis

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