Should a patient with ulcerative pancolitis continue treatment with Entyvio (vedolizumab) 300 mg IV every 8 weeks?

Continuation of Vedolizumab Therapy is Medically Necessary and Strongly Supported

This patient should continue vedolizumab 300 mg IV every 8 weeks for maintenance therapy, as they have achieved and maintained clinical remission on this regimen, meeting all guideline-based criteria for ongoing treatment. 1, 2

Guideline-Based Support for Continuation

The British Society of Gastroenterology (2025) recommends vedolizumab for maintenance of remission in patients with moderate to severe ulcerative colitis, with moderate certainty evidence. 1 The ECCO guidelines provide a strong recommendation for continued vedolizumab maintenance therapy in patients who have achieved remission with vedolizumab induction, based on moderate-quality evidence. 1

Stopping vedolizumab maintenance therapy in a responding patient without documented treatment failure or intolerable adverse effects contradicts evidence-based guidelines and significantly increases risk of disease relapse. 2

Evidence of Treatment Response in This Patient

This patient demonstrates clear clinical response and remission:

• Complete symptom resolution: Reports 1-2 formed non-bloody stools daily, denies abdominal pain, rectal bleeding, and all gastrointestinal symptoms. [@case documentation@]

• Endoscopic improvement: Colonoscopy showed Mayo Score 1 (mild inflammation) with quiescent disease compared to previous examination, representing mucosal healing. [@case documentation@]

• Sustained remission: Patient has maintained clinical response through multiple infusion cycles on the every 8-week maintenance schedule. [@case documentation@]

• Excellent tolerability: No adverse events reported, patient states "doing great" on current regimen. [@case documentation@]

Every 8-Week Dosing is the Evidence-Based Standard

The GEMINI I trial established that vedolizumab 300 mg every 8 weeks achieved clinical remission in 41.8% of patients at week 52, compared to only 15.9% with placebo (adjusted difference 26.1 percentage points, P<0.001). 3 Critically, no significant difference in efficacy exists between every 4-week and every 8-week dosing, establishing every 8 weeks as the appropriate standard maintenance interval. 1, 3

The FDA-approved dosing for maintenance therapy is 300 mg IV every 8 weeks after completion of induction dosing. 4 Guidelines explicitly state that "in the absence of controlled data, dose intensification to 4-week dosing is not advocated." 5

Long-Term Safety Profile Supports Continuation

Vedolizumab demonstrates an excellent safety profile supporting long-term use:

• Adverse event rates similar to placebo, with most common events being mild: headache, nausea, abdominal pain, fatigue, and nasopharyngitis. 2, 6

• No cases of progressive multifocal leukoencephalopathy reported in approximately 3000 patients with median exposure of 18.8 months. 2, 6

• No increased risk of serious infections compared to placebo in clinical trials. 1, 2

• Long-term data over 8 years showed no new or unexpected safety concerns, with continuous vedolizumab maintaining clinical response in 33% of UC patients at 400 treatment weeks. 6

Addressing the Milliman Care Guidelines Criteria

The documentation review raises questions about two criteria that warrant clarification:

Regarding "inadequate response to corticosteroids": The patient's current quiescent disease state and sustained remission on vedolizumab maintenance therapy demonstrates they are a responder to vedolizumab who completed successful induction. 2 The relevant criterion for maintenance therapy is documented response to vedolizumab induction, which this patient clearly demonstrates. 1, 2

Regarding "inadequate response to TNF inhibitor or immunomodulator": While not explicitly documented in the provided records, the patient's current treatment with vedolizumab as maintenance therapy after successful induction indicates they met initial criteria for vedolizumab initiation. 1 For ongoing maintenance therapy, the critical criterion is sustained response to vedolizumab itself, which is clearly documented. 1, 2

Clinical Algorithm for Decision-Making

For patients on vedolizumab maintenance therapy, continuation is indicated when:

1. Clinical response achieved: Patient demonstrates symptom control (met - patient asymptomatic with formed stools, no bleeding). [@case documentation@]

2. Objective improvement documented: Endoscopic or laboratory evidence of disease control (met - Mayo Score 1, quiescent disease on colonoscopy). [@case documentation@]

3. Tolerability maintained: No serious adverse events or intolerance (met - no adverse events reported). [@case documentation@]

4. Standard dosing interval: Every 8 weeks is appropriate (met - current regimen). 4, 3

All four criteria are satisfied in this patient, strongly supporting continuation of therapy. 1, 2

Common Pitfalls to Avoid

• Do not discontinue vedolizumab in patients who have achieved remission without clear evidence of treatment failure, as this leads to preventable disease relapse. 2

• Do not require repeated demonstration of prior treatment failures for patients already established on successful maintenance therapy - the relevant criterion is response to current therapy. 1, 2

• Do not intensify to every 4-week dosing without documented loss of response on every 8-week dosing, as guidelines do not support routine intensification. 5, 7