In May 2014, Vedolizumab was approved by the FDA for adult patients with moderately to severely active ulcerative colitis or Crohn’s disease who have had an inadequate response to, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response to, were intolerant to, or demonstrated dependence on corticosteroids.
How does it work?
Vedolizumab is designed to specifically antagonize the alpha 4 beta 7 integrin receptor, which is expressed on certain circulating white blood cells that have been shown to play a role in the inflammatory process in CD and UC.
In other words, Vedolizumab works by blocking certain white blood cells in the blood stream from entering the intestine where they cause inflammation.
When will I feel better?
In the clinical trials, approximately 30% of people responded by week 6. At week 52, approximately 46% of people had response.
How is it administered?
Vedolizumab will be given as a 300mg IV infusion (over a period of about 30 minutes) at week 0, week 2 and week 6 (induction) then every 8 weeks (maintenance). It will be discontinued if there is no response by week 14.
What are the possible side effects?
In general, studies revealed that Vedolizumab is a safe drug, with minimal side effects because its mechanism of action is gut specific. Some of the possible side effects include:
- Infusion reactions
- Liver abnormalities
- Increased r/f infection
- Headaches, nausea, fatigue
- Abdominal pain
- Nasopharyngitis (the common cold)
- Development of antibodies (rare)
*As of December 1, 2013, > 1,000 patients with IBD have been exposed to > 24 infusions of Vedolizumab, with 1,100 patients in an ongoing long term study, and there have been NO cases of PML thus far. Because Vedolizumab is gut specific, there is essentially very limited risk of developing PML while taking this medication. However, the package insert still reports it as a possible risk.
Let your doctor know if you have…
- an active infection and/or fever
- previous infection with TB
- a history of hepatitis
- Any changes in speech, balance, or personality while taking this med
What if I’m pregnant or planning a family?
Women planning to become pregnant should discuss their treatment options with their care team in clinic. It is generally advised that you continue to take your maintenance treatment throughout pregnancy, as an uncontrolled flare up of your disease can be harmful to the baby.
There have been no studies with Vedolizumab & pregnant women, though there have been animal studies:
No fetal harm was observed in animal reproduction studies with rabbits & monkeys that received doses up to 20x the recommended human dose of Vedolizumab.
In addition, women on Vedolizumab should breastfeed with caution, as the medication was detected in the milk of lactating monkeys who received it. It is unknown whether it is expressed in human milk.
How long will I need to take this medication?
Vedolizumab is designed to be taken as maintenance treatment to prevent and treat flare-ups of your disease. You will therefore need to take the drug for many years, even during times when you are well, as not taking them may increase the risk of you becoming unwell.
Remember, you may get infections more easily while taking this medication, so stay away from people with colds, the flu, and other infections whenever possible. Talk to your care team before getting immunized with live virus vaccines (measles, varicella, etc.), however flu vaccinations are generally recommended.