Is continuation of vedolizumab (Entyvio) therapy medically necessary for a patient with Crohn's disease who has not shown a favorable response to initial treatment and is experiencing worsening symptoms?

Vedolizumab Continuation is NOT Medically Necessary in This Case

This patient should not receive continued vedolizumab maintenance therapy because there is no documented evidence of a favorable response to the initial induction treatment, and the clinical notes explicitly state the provider is switching to Rinvoq and stopping the current biologic regimen. 1

Critical Missing Documentation

The fundamental requirement for vedolizumab maintenance therapy is documented symptomatic response to induction therapy, which must be assessed between 10-14 weeks after initiation. 1 In this case:

• No response documentation exists: The request lacks any clinical evidence showing the patient achieved symptomatic improvement, clinical remission, or endoscopic improvement during the vedolizumab induction phase 1
• Active disease progression: The patient is experiencing worsening symptoms including abdominal pain, diarrhea, urgency, and rectal bleeding—clear indicators of treatment failure 1
• Provider's own treatment plan contradicts the request: The clinical notes state the provider is "switching to Rinvoq and stopping Skyrizi" with no mention of continuing vedolizumab 1

Guideline Requirements for Vedolizumab Maintenance

The Canadian Association of Gastroenterology provides explicit criteria that this patient fails to meet:

• Mandatory response assessment: Patients must be evaluated for symptomatic response to vedolizumab between 10-14 weeks to determine if therapy should continue (conditional recommendation, very low-quality evidence) 1
• Response-dependent continuation: Only patients who have achieved symptomatic response with vedolizumab induction therapy should receive continued vedolizumab to maintain complete remission (strong recommendation, moderate-quality evidence) 1
• No response = therapy modification required: Without documented response, therapy must be modified rather than continued 1

Clinical Timeline Analysis

Reviewing the patient's treatment history reveals vedolizumab was previously discontinued:

• Initial vedolizumab trial failed: Patient was diagnosed in the past and started Entyvio but stopped after only 3 infusions due to fatigue [@case documentation@]
• Subsequent treatments: Patient then required Skyrizi and Rinvoq combination therapy, suggesting vedolizumab was inadequate [@case documentation@]
• Current flare on different therapy: The documented flare occurred while on Skyrizi (second maintenance injection), not vedolizumab [@case documentation@]

Evidence Supporting Response-Based Continuation

The GEMINI trials, which form the evidence base for vedolizumab approval, demonstrate that:

• Week 6 response predicts maintenance benefit: In GEMINI 2, vedolizumab showed significantly greater symptomatic response at week 6 (47.1% vs 25.5% placebo), and only responders were randomized to maintenance therapy 1
• Maintenance only benefits responders: At week 52, among patients who responded to induction, 39-44.8% achieved clinical remission with continued vedolizumab versus 15.9-21.6% with placebo 1
• No benefit without initial response: The trials excluded non-responders from maintenance phases, providing no evidence that continuing vedolizumab benefits patients who don't respond to induction 1

Real-World Effectiveness Data

The US VICTORY Consortium study of 212 patients with moderate-severe Crohn's disease found:

• Response rates lower in TNF-exposed patients: Patients with prior TNF-antagonist exposure were significantly less likely to achieve clinical remission (HR 0.40; 95% CI: 0.20-0.81) 2
• Severe disease activity predicts poor response: Those with severe disease activity were less likely to achieve both clinical remission (HR 0.54) and mucosal healing (HR 0.54) 2
• This patient has both risk factors: Prior biologic exposure (Skyrizi, Rinvoq) and severe active disease with rectal bleeding 2

AGA Guideline Position

The 2021 AGA Clinical Practice Guidelines state:

• Conditional recommendation for vedolizumab: In adults with moderate to severe CD, the AGA suggests (not recommends) vedolizumab over no treatment for induction and maintenance, with low certainty evidence for induction and moderate for maintenance 1
• Stronger alternatives exist: The AGA gives stronger recommendations for infliximab, adalimumab, and ustekinumab compared to vedolizumab 1

Common Pitfalls to Avoid

Do not approve maintenance therapy based solely on:

• Prior authorization of induction doses without documented response assessment 1
• Presence of Crohn's disease diagnosis alone without treatment response documentation 1
• Provider request without supporting clinical evidence of benefit 1

Do require:

• Objective evidence of symptomatic improvement (decreased CDAI, Harvey-Bradshaw Index, or symptom resolution) 1
• Documentation of response assessment at 10-14 weeks post-induction 1
• Clear treatment plan indicating vedolizumab continuation rather than switching to alternative therapy 1

Appropriate Next Steps

Based on the provider's documented plan to use Rinvoq and the patient's treatment failure:

• Rinvoq (upadacitinib) is appropriate: The AGA recommends ustekinumab (strong recommendation, moderate evidence) for patients who fail other therapies, and JAK inhibitors like upadacitinib represent a reasonable alternative 1
• Reassess after adequate trial: If the provider wishes to retry vedolizumab in the future, a new induction course with proper response assessment at 10-14 weeks would be required 1
• Consider endoscopic assessment: The patient's last colonoscopy showed severe proctosigmoid ulcerative colitis, and repeat endoscopy could guide therapy selection [@case documentation@]