What is the comparison between Entyvio (natalizumab) and Tremfya (guselkumab) for treating ulcerative colitis?

Comparison of Tremfya (Guselkumab) vs Entyvio (Vedolizumab) for Ulcerative Colitis

Vedolizumab (Entyvio) is superior to guselkumab (Tremfya) for treating ulcerative colitis based on current guidelines and evidence, with vedolizumab having stronger recommendation strength, more established efficacy data, and a favorable safety profile specifically for ulcerative colitis. 1

Efficacy Comparison

Vedolizumab (Entyvio)

• Strongly recommended by the American Gastroenterological Association (AGA) for moderate-to-severe ulcerative colitis 1
• Demonstrated superior efficacy compared to adalimumab in the head-to-head VARSITY trial (34.2% vs. 24.3% clinical remission) 1
• Clinical remission rates in placebo-controlled trials: RR 2.22 (95% CI, 1.36–3.64) for induction and RR 2.31 (95% CI, 1.63–3.28) for maintenance 1
• Specifically suggested by AGA as a first-line biologic agent for biologic-naïve patients 1

Guselkumab (Tremfya)

• Recently approved for ulcerative colitis with conditional recommendation by AGA 1
• In the QUASAR phase 3 trial, showed clinical remission rates of 23% at induction week 12 (vs 8% placebo) 2
• Maintenance clinical remission at week 44: 50% with 200mg SC every 4 weeks and 45% with 100mg every 8 weeks (vs 19% placebo) 2
• Ranked high in improving health-related quality of life in recent network meta-analyses 3, 4

Safety Profile

Vedolizumab (Entyvio)

• Gut-selective mechanism of action with favorable safety profile 5
• 32% lower risk of serious infections compared to TNF antagonists 1
• Well-tolerated in clinical trials with safety profiles similar to placebo 5
• Available in both IV and subcutaneous formulations for maintenance therapy 1

Guselkumab (Tremfya)

• Generally favorable safety profile in clinical trials 2
• Most common adverse events: ulcerative colitis flares, COVID-19, and arthralgia 2
• No reports of active tuberculosis, anaphylaxis, serum sickness, or clinically important hepatic disorders in the QUASAR trials 2

Treatment Algorithm

1. For biologic-naïve patients with moderate-to-severe UC:

   • Vedolizumab is preferred over guselkumab based on stronger recommendation strength and established efficacy data 1, 5
   • Standard dosing: 300mg IV at weeks 0,2,6, then every 8 weeks 5
   • Evaluate response between weeks 8-14 5

2. For patients with prior TNF-antagonist failure:

   • Both medications are effective options
   • Consider vedolizumab for patients with higher risk of infections 1
   • Consider guselkumab for patients who failed multiple biologics, as it targets a different pathway (IL-23) 2, 4

3. Dose optimization if inadequate response:

   • For vedolizumab: Consider increasing frequency to every 4 weeks 5
   • For guselkumab: Data supports 200mg SC every 4 weeks or 100mg every 8 weeks 2

Important Considerations

• Mechanism differences: Vedolizumab is a gut-selective α4β7 integrin antagonist, while guselkumab is an IL-23p19 inhibitor 1, 2
• Administration route:
  • Vedolizumab: IV induction with option for SC maintenance
  • Guselkumab: IV induction followed by SC maintenance 2
• Monitoring requirements: Both require tuberculosis screening before initiation 5
• Insurance coverage: Vedolizumab typically has better coverage as it's been approved longer for UC

Potential Pitfalls

• Delayed response: Both medications may take 8-14 weeks to show full clinical benefit; avoid premature discontinuation 5
• Infection risk: While both have favorable safety profiles, patients with history of serious infections may benefit more from vedolizumab's gut-selective mechanism 1, 5
• Prior treatment failure: Response rates to both medications may be lower in patients who have failed multiple previous biologics 1
• Combination therapy: Limited data exists on combining either medication with immunomodulators specifically for UC 5

In conclusion, while both medications are effective for ulcerative colitis, vedolizumab currently has stronger guideline support, more established efficacy data, and a well-documented safety profile specifically for UC treatment.