Biologics: Vedolizumab

Vedolizumab (trade name Entyvio) is a monoclonal antibody which binds to integrin α4β7 (LPAM-1, lymphocyte Peyer's patch adhesion molecule 1), a gut selective integrin and exerts anti-inflammatory properties. It showed to be effective and safe for patients suffering from moderate-to-severe Crohn’s disease. It is approved and indicated for adult patients with moderately to severely active CD who have had an inadequate response with, lost response to, or were intolerant to a TNF blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids for:

  • achieving clinical response
  • achieving clinical remission
  • achieving corticosteroid-free remission

Active disease

Vedolizumab is able to induce remission in moderate to severe CD. Efficacy has been shown in subgroups without anti-TNF exposure or after TNF exposure or failure There are some data available that Vedolizumab might have a beneficial effect on the closure of perianal fistulas.

Maintaining remission

Vedolizumab is able to maintain remission in moderate to severe CD.

Prevention of post-surgical recurrence

Currently, there are no data available as to whether Vedolizumab can prevent post-operative recurrence.

Stopping therapy

There are no data if, and when a therapy with Vedolizumab can or should be stopped. Until then, the same predictive factors for disease relapse after stopping therapy as known for TNF-a inhibitors might apply. In the GEMINI trial, patients being retreated with Vedolizumab after discontinuation of the drug regained efficiency.

Dosing, administration and monitoring

Before treatment

  • Exclude active infection, including TB.

Dosing

  • Induction therapy: 300 mg i.v., week 0, 2, and 6. If the response is not adequate, an additional application of 300 mg i.v. at week 10 might given.
  • Maintaining remission: every 8 weeks after the last infusion. Increase to Q4W if loss of response. Vedolizumab should be discontinued in patients who do not show evidence of therapeutic benefit by Week 14.

Follow-up

There is no specific follow up required.

Red flag interactions

Stop or pause therapy if side effects occur. There is no black box warning.

Adverse effects

The most common adverse events, with relatively low frequency are: headache, nasopharyngitis, nausea, arthralgia, upper respiratory infection, and fatigue. The response to oral vaccination might be reduced. Although less common, infusion and serious allergic reactions might occur. There is no until now identified systemic immunosuppressive activity.

Special situations

Pregnancy

Animal studies showed no fetal harm or adverse effects on pre- or post-natal. However, there are no controlled data in human pregnancy and thus, this drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: B

Breastfeeding

There are no data about the excretion of Vedolizumab in the human breast milk. Exercise caution when administering to a nursing woman.

Surgery

Data on the effect of Vedolizumab on the post-operative outcome are rare. However, one retrospective observation suggested a higher postoperative infection rate.

Paediatrics

Reports on paediatric populations receiving Vedolizumab showed efficiency. However, no controlled trial has been performed so far in this population.

Elderly

There are no data on the use of Vedolizumab especially in elderly IBD patients. However, subgroups analysis of the GEMINI trial showed efficiency also in UC patients older than 55 years. The favourable side effect profile might encourage its use in elderly patients, however, no data are available.

Vedolizumab (trade name Entyvio) is a monoclonal antibody which binds to integrin α4β7 (LPAM-1, lymphocyte Peyer's patch adhesion molecule 1), a gut selective integrin and exerts anti-inflammatory properties. It showed to be effective and safe for patients suffering from moderate-to-severe ulcerative colitis. It is approved and indicated for adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids to:

  • induce and maintain clinical response
  • induce and maintain clinical remission
  • improve endoscopic appearance of the mucosa
  • achieve corticosteroid-free remission

Active disease

Vedolizumab is able to induce remission in moderate to severe UC, regardless of the localisation. It is also effective in patients treated previously with TNF-inhibitors.

Maintaining remission

Vedolizumab is able to maintain remission in moderate to severe UC, regardless of its localisation.

Stopping therapy

There are no data if, and when a therapy with Vedolizumab can or should be stopped. Until then, the same predictive factors for disease relapse after stopping therapy as known for TNF-a inhibitors might apply. In the GEMINI trial, patients being retreated with Vedolizumab after discontinuation of the drug regained efficiency.

Dosing, administration and monitoring

Before treatment

  • Exclude active infection, including TB.

Dosing

  • Induction therapy: 300 mg i.v., week 0, 2, and 6. Continued therapy for patients with ulcerative colitis should be carefully reconsidered if no evidence of therapeutic benefit is observed by Week 10.
  • Maintaining remission: every 8 weeks. Increase to Q4W if loss of response.
  • Vedolizumab should be discontinued in patients who do not show evidence of therapeutic benefit by Week 14.

Follow-up

There is no specific follow up required.

Red flag interactions

Stop or pause therapy if side effects occur. There is no black box warning.

Adverse effects

The most common adverse events, with relatively low frequency are: headache, nasopharyngitis, nausea, arthralgia, upper respiratory infection, and fatigue. The response to oral vaccination might be reduced. Although less common, infusion and serious allergic reactions might occur. There is no until now identified systemic immunosuppressive activity.

Special situations

Pregnancy

Animal studies showed no fetal harm or adverse effects on pre- or post-natal. However, there are no controlled data in human pregnancy and thus, this drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: B

Breastfeeding

There are no data about the excretion of Vedolizumab in the human breast milk. Exercise caution when administering to a nursing woman.

Surgery

Data on the effect of Vedolizumab on the post-operative outcome are rare. However, one retrospective observation suggested a higher postoperative infection rate.

Paediatrics

Reports on paediatric populations receiving Vedolizumab showed efficiency. However, no controlled trial has been performed so far in this population.

Elderly

There are no data on the use of Vedolizumab especially in elderly IBD patients. However, subgroups analysis of the GEMINI trial showed efficiency also in UC patients older than 55 years. The favourable side effect profile might encourage its use in elderly patients, however, no data are available.

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