What is the recommended use and dosage of Entyvio (vedolizumab) for treating ulcerative colitis and Crohn's disease?

Recommended Use and Dosage of Entyvio (Vedolizumab) for Ulcerative Colitis and Crohn's Disease

Entyvio (vedolizumab) is strongly recommended for treating moderate-to-severe ulcerative colitis and Crohn's disease in adults who have failed conventional therapies or other biologics, with a specific dosing regimen of 300 mg IV at weeks 0,2, and 6, followed by maintenance dosing every 8 weeks or subcutaneous 108 mg every 2 weeks after initial IV induction. 1, 2

Indications

• Indicated for adults with moderately to severely active ulcerative colitis (UC) 1, 2
• Indicated for adults with moderately to severely active Crohn's disease (CD) 1, 2
• Particularly effective in patients who have failed to achieve complete remission with corticosteroids, thiopurines, methotrexate, or anti-TNF therapy 1

Dosing Regimen

Intravenous Administration

• Week 0: 300 mg by intravenous infusion over approximately 30 minutes 2
• Week 2: 300 mg by intravenous infusion over approximately 30 minutes 2
• Week 6: 300 mg by intravenous infusion over approximately 30 minutes 2
• Maintenance: 300 mg by intravenous infusion every 8 weeks thereafter 2

Subcutaneous Administration Option

• Patients may switch to subcutaneous injection after receiving two IV doses at Weeks 0 and 2 2
• Subcutaneous dose: 108 mg administered once every 2 weeks 2
• First subcutaneous dose replaces the next scheduled IV infusion for patients switching from IV maintenance 2

Efficacy Assessment and Treatment Duration

Ulcerative Colitis

• Evaluate for symptomatic response between 6-8 weeks to determine need for therapy modification 1
• Discontinue therapy if no evidence of therapeutic benefit by Week 14 2
• Maintenance therapy should be continued in patients who achieve symptomatic response to induction therapy 1

Crohn's Disease

• Evaluate for symptomatic response between 10-14 weeks to determine need for therapy modification 1
• Discontinue therapy if no evidence of therapeutic benefit by Week 14 2
• Continue vedolizumab therapy in patients who achieve symptomatic response with induction therapy 1

Efficacy in Clinical Trials

• For UC: Significantly higher rates of clinical response and remission compared to placebo at both 6 and 52 weeks 3
• For CD: Strong recommendation with moderate-quality evidence for induction of remission in patients who failed other therapies 1
• Early onset of symptom improvement observed as early as week 2, with continued improvement through week 6 4
• By week 6,45% of UC patients showed rectal bleeding improvement 4
• By week 6,32% of CD patients achieved stool frequency improvement 4

Placement in Treatment Algorithm

Ulcerative Colitis

• Recommended as a first-line biologic option for moderate-to-severe UC failing conventional therapy 1
• In biologic-naïve patients, vedolizumab or infliximab are suggested over adalimumab for induction of remission 1
• The VARSITY trial showed superior clinical remission rates with vedolizumab compared to adalimumab at 52 weeks (31.3% vs 22.5%) 1

Crohn's Disease

• Strongly recommended for patients who fail to achieve complete remission with corticosteroids, thiopurines, methotrexate, or anti-TNF therapy 1
• Conditionally recommended for patients who fail to achieve or maintain corticosteroid-free symptomatic remission with anti-TNF therapy 1

Safety Considerations

• Generally well-tolerated with a favorable safety profile 3, 5
• As a gut-selective α4β7 integrin antagonist, vedolizumab has not been associated with progressive multifocal leukoencephalopathy (PML), unlike the less selective natalizumab 3, 5
• Common adverse effects include nasopharyngitis, headache, arthralgia, nausea, and upper respiratory tract infections 5
• Update immunizations before initiating therapy 2
• Should be administered by healthcare providers prepared to manage hypersensitivity reactions 2

Important Clinical Pearls

• Vedolizumab's gut-selective mechanism provides a favorable safety profile compared to less selective agents 3, 5
• Response may be slower than with anti-TNF agents, particularly in Crohn's disease patients 3, 6
• Anti-TNF-naïve patients may experience greater and faster stool frequency improvements compared to anti-TNF-experienced patients 4
• Subcutaneous formulation offers convenience after initial IV induction, potentially improving adherence 2