Overview:
Vedolizumab is a drug developed by Millennium Pharmaceuticals. It belongs to the class of anti-inflammatory, antineoplastic, immunotherapy, and monoclonal antibody drugs. Vedolizumab is used to treat autoimmune conditions like Crohn's disease and ulcerative colitis. These conditions affect the digestive system and cause symptoms like bloody diarrhea, abdominal cramps, and fatigue. Vedolizumab is approved to treat ulcerative colitis and Crohn's disease for those who do not respond to the first line of treatment. Its primary action is to block the inflammatory cells from reaching the site of inflammation.
The first treatment choice for ulcerative colitis often involves pharmaceutical therapy or surgery. The medications work differently, it can vary between different people, depending on the severity of the condition. The choice of drugs should be assessed based on side effects and effectiveness. Crohn’s disease treatment involves anti-inflammatory drugs, immune suppressors, antibiotics, and nutrition therapy. Vedolizumab was recently approved for Crohn’s disease and is known to have fewer side effects.
How Does Vedolizumab Work?
Vedolizumab works by reducing inflammation by interfering with T-cell movement to the intestines. Addressin is a molecule that plays an essential role in leukocyte (type of white blood cell) trafficking in the gut. α4β7 is a receptor that recognizes addressin during inflammation. The potential effect of Vedolizumab on these receptors and T-cell migration to the intestines was demonstrated in vitro. Further investigations reported that Vedolizumab reduced the adhesion of CD4+ and CD8+ T-cells to the addressin molecule.
In contrast, some studies reported differences in α4β7 receptor expression on lymphocytes, concluding that Vedolizumab may block the migration of pro-inflammatory cells into the gut. Additionally, Vedolizumab treatment is known to be associated with clinical remission by reducing receptor α4β7 expression on mucosal CD4+ T-cells, which together could reduce the recruitment of pro-inflammatory cells to the gut mucosa. The bottom line is that Vedolizumab acts by selectively inhibiting the migration of specific subtypes of T-cell immigration to the intestines, thereby reducing the inflammatory cascade.
Uses of Vedolizumab
1. Ulcerative Colitis:
Vedolizumab is indicated for adult patients with moderate to severe ulcerative colitis. The drug is preferred to achieve corticosteroid-free control of ulcerative colitis in patients who do not respond or are intolerant to tumor necrosis factor (TNF) blockers or immunomodulators. Vedolizumab induces and maintains clinical response and clinical remission, thereby improving the health of intestinal mucosa.
2. Crohn’s Disease:
Similar to ulcerative colitis, some patients do not respond to corticosteroid therapy and tumor necrosis factor (TNF) blockers in Crohn’s disease. In such cases, Vedolizumab is indicated to achieve corticosteroid-free response and clinical remission of the disease. Vedolizumab is also approved by the FDA (Food and Drug Administration) for the treatment of adult patients with Crohn’s disease.
Dosage Restrictions
The recommended dose of Vedolizumab in adults with ulcerative colitis or Crohn's disease is 300 mg intravenous infusion at 0, 2, and 6 weeks, and then every 8 weeks. 5 ml (300 mg) of reconstituted Vedolizumab solution should be added to 250 ml of sterile 0.9 % Sodium chloride solution.
Warning
Hypersensitivity Reactions and Infusion-Related Reactions:
Treatment with Vedolizumab can rarely trigger a severe allergic reaction leading to anaphylaxis. The symptoms include difficulty breathing, flushing, rash, urticaria, increased blood pressure and heart rate, and constriction of the bronchus. However, the majority of the allergic reactions are mild to moderate, and their time of onset varies from immediate onset to delayed onset (several hours post-infusion). If an anaphylaxis reaction occurs, the infusion should be stopped immediately, and appropriate antihistamine and epinephrine should be administered.
Risk of Developing Infections:
Patients treated with Vedolizumab are at an increased risk of developing infections involving the upper respiratory tract and nasal mucosa. Severe conditions like tuberculosis, sepsis, anal abscess, meningitis, and colon infections have a chance of occurrence. Patients must be screened for tuberculosis before starting the treatment. In patients with pre-existing active infections, treatment with Vedolizumab is not recommended unless the infections are in control. Patients must be screened for tuberculosis before starting the treatment. Vedolizumab can be started after taking the necessary precautions for patients likely to develop an infection.
Progressive Multifocal Leukoencephalopathy (PML):
PML is a rare fatal opportunistic infection caused by the John Cunningham (JC) virus in immunocompromised patients. Patients undergoing Vedolizumab treatment should be monitored and screened for progressive multifocal leukoencephalopathy with regular screening for unexplained neurologic symptoms. Although it is extremely rare, the risk of PML cannot be ruled out. PML signs and symptoms include weakness in the body and limbs, visual disturbances, impaired thinking, disorientation, memory loss, confusion, and personality changes. The treatment with Vedolizumab should be stopped immediately, and the patient should be referred to a neurologist for further evaluation, if PML is suspected.
Liver Injury
If the liver enzymes are elevated (transaminase and bilirubin) without evidence of obstruction, it is generally recognized as a significant marker of severe liver injury. Elevation of transaminase and bilirubin in patients receiving Vedolizumab is suggestive of liver damage. The condition may be severe and lead to death or the need for liver transplantation. In patients with jaundice or other evidence of significant liver injury, Vedolizumab should be stopped right away.
Live and Oral Vaccines
Before initiating treatment with Vedolizumab, all patients should be immunized according to current immunization guidelines. Patients receiving Vedolizumab can receive non-live vaccines (e.g., influenza vaccine injection) and live vaccines after assessing the benefits and risks. There is no evidence of secondary infection by live vaccines in patients receiving Vedolizumab.
For Patients
What is Ulcerative Colitis?
Ulcerative colitis is a type of inflammatory bowel disease (IBD) characterized by inflammation and ulceration in the digestive tract. It typically affects the inner lining of the colon and rectum of the large intestine. It is a progressive condition that worsens over time, leading to life-threatening complications.
What Causes Ulcerative Colitis?
Although the exact reason for the occurrence of ulcerative colitis is unknown, autoimmunity is known to play a role. When the body’s immune system considers the native cells of the digestive tract as foreign, an immune response is triggered. The reason behind this confusion is still a question to medical science. Several factors like stress, infection, and heredity factors are thought to play a role.
What Are the Types of Ulcerative Colitis?
Ulcerative Proctitis: Theaffected area is confined to the rectum (anus). Inflammation of the rectum leads to rectal bleeding, and there might be an absence of other symptoms of the disease.
Proctosigmoiditis: The sigmoid colon (lower end of the colon) and the rectal areas get inflamed, leading to symptoms like bloody and loose stools, abdominal cramps, pain, etc.
Left-Sided Colitis: The rectum, sigmoid colon, and descending colon are affected. The symptoms are similar to that of proctosigmoiditis, but here they are confined to the left side.
Pancolitis: In this case, the entire colon is affected. The symptoms are severe and often cause bloody diarrhea, abdominal cramps and pain, fatigue, and unexplained weight loss.
What Are the Symptoms of Ulcerative Colitis?
Common symptoms of ulcerative colitis are:
1. Diarrhea with blood or pus.
2. Pain and cramps in the abdomen.
3. Bleeding while defecating.
4. Urge to pass stools.
5. Weight loss, weakness, and fatigue.
6. Fever, malaise.
7. Restricted growth in children.
What Are the Complications Associated With Ulcerative Colitis?
1. Severe blood loss because of internal bleeding.
2. Perforation in the colon.
3. Dehydration.
4. Inflammation in other body parts like skin, joints, and eyes.
5. Colon swelling.
6. Risk of colon cancer.
7. Risk of blood clots.
Learn About Crohn’s Disease:
Crohn’s disease is similar to ulcerative colitis, but the only difference is that the entire gut can get affected by Crohn's disease. It is also a type of inflammatory bowel disease (IBD), characterized by inflammation of the entire gut from mouth to anus. In Crohn's disease, there is the involvement of the total thickness of the gut wall. The condition leads to severe complications and life-threatening conditions. The symptoms of Crohn’s disease are similar to that of ulcerative colitis.
What Causes Crohn’s Disease?
The cause of Crohn’s disease is not yet determined. Several factors are known to play a vital role.
1. Immune System: Autoimmunity is thought to be why this occurrence leads to an abnormal immune response.
2. Genetic Predisposition:The disease might occur in people who have a family history of Crohn’s disease. However, a majority of cases are sporadic.
What Are the Risk Factors Associated With Crohn’s Disease?
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Age: Younger patients around the age of 30 are more likely to develop this condition.
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Ethnicity: Eastern European and Jewish descendants are more likely to develop Crohn’s disease. Whites are more affected than black people.
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Smoking: Cigarette smoking increases the risk of the disease.
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NSAIDs (Nonsteroidal Anti-inflammatory Drugs): These medications may indirectly affect by worsening the symptoms of Crohn’s disease.
What Are the Complications Associated With Crohn’s Disease?
The condition causes several complications:
1. Bowel Obstruction: When the disease progresses, the entire thickness of the gut mucosa obstructs the bowel movement.
2. Ulcers: Long-time inflammation results in ulceration of the digestive tract (anywhere from the mouth to the anus).
3. Fistulas: It is an abnormal connection between the organs that commonly develops around the anus.
4. Fissures in the Anus: Tears in the tissues that line the anus, often leading to pain.
5. Malnutrition: Intestines are functionally disabled to absorb nutrition to keep the body healthy. Patients with Crohn’s disease develop anemias.
6. Risk of Colon Cancer: Crohn’s disease increases the risk of colon cancer, and hence regular screening is necessary.
Learn More About Vedolizumab
Why and When to Switch to Vedolizumab?
For Ulcerative Colitis:
Several groups of drugs were initially used to treat ulcerative colitis. Anti-inflammatory drugs like corticosteroids are the first choice. Corticosteroids cannot be given for the long term as they have side effects. A combination of immune system suppressor drugs is given, but these drugs have serious side effects like blood clots. Vedolizumab belongs to an alternative group of drugs called biologics. These drugs target proteins of the immune system. Vedolizumab is effective in patients who do not respond to other groups of drugs.
For Crohn’s Disease:
The treatment for Crohn’s disease involves a symptomatic approach by combining multiple drugs. The goal is to achieve a good long-term prognosis with almost negligible side effects. Anti-inflammatory drugs in combination with immune-system suppressors are the first choice for treatment. Vedolizumab was recently approved to treat Crohn’s disease, and it works by targeting the immune system proteins. Vedolizumab is known to cause the least adverse reactions and also maintains a good clinical remission and response.
What Differentiates Vedolizumab From Other Conventional Medicines?
Anti-inflammatory Versus Vedolizumab
Anti-inflammatory drugs act by reducing inflammation or by suppressing the immune cells. Corticosteroids work by interfering with the inflammatory pathway and causing conformational changes in the receptor molecules, thereby reducing inflammation. Vedolizumab targets the receptors that recruit T-lymphocytes (a type of white blood cell) that are responsible for the inflammatory changes.
How Does Vedolizumab Work?
1. Lymphocyte Migration to the Intestines:
Inflammatory cells, including T-lymphocytes, migrate in large numbers into the intestinal tissues that contribute to the inflammatory changes.
2. Interaction Between T-Lymphocytes and the Receptor Molecules:
The receptor molecule called addressin or MAdCAM-1 (mucosal vascular addressin cell adhesion molecule 1) is expressed on the surface of the gut intestine, to which α4β7 molecule is present on the T-lymphocytes binds.
3. Blocking Interaction:
Vedolizumab binds to the α4β7 molecule on the T-lymphocytes and blocks its interaction with MAdCAM-1. Thus, T-lymphocyte migration to the gut lining is inhibited.
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T-lymphocytes: A type of white blood cell that plays an essential role in the body’s immune system.
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α4β7 Molecule: It is an integrin molecule that plays a role in the adhesion of immune cells to the receptors on the gut lining.
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MAdCAM-1: Molecules expressed on the gut mucosa bind with the immune cells' receptors triggering an immune response.
What Are the Effects of Vedolizumab?
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α4β7 receptors get saturated with Vedolizumab molecules on subsets of circulating lymphocytes involved in the gut immune response.
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Vedolizumab does not elevate other immune cells such as neutrophils, basophils, etc.
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The drug also reduces the inflammation in the gut mucosa and promotes its health.
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Vedolizumab does not affect the total T-lymphocyte count.
Things to Tell Physicians Before They Prescribe Vedolizumab:
1. A proper history of signs and symptoms, history of medications, laboratory test reports, etc.
2. Any known history of allergy to medications such as Penicillin or any other drugs.
3. Exposure to patients with diseases like tuberculosis or a history of tuberculosis if already diagnosed.
4. Immunization records should be discussed before starting Vedolizumab treatment.
5. Any immune-compromised states like HIV (human immunodeficiency virus), long-term corticosteroid therapy, and history of diabetes should be mentioned.
6. Evaluation of liver problems like hepatitis if present.
7. History of past surgeries or anticipated future surgeries.
8. All past and current medications with doses must be explained.
9. Women planning for pregnancy and lactating mothers should abstain from Vedolizumab treatment.
Starting Vedolizumab:
How to Take Vedolizumab?
Vedolizumab is administered by a healthcare professional by intravenous (IV) infusion through a vein. It is given for approximately a 30-minute period. The subsequent doses are given at two and six weeks after the first dose. Then, the dose is repeated every eight weeks after that.
Common Side Effects to Look Out For:
1. Signs and symptoms of allergy like redness at the injection site, dyspnea (difficulty in breathing), bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate.
2. Runny nose, stiffness in the nose, and sore throat indicate upper respiratory tract infection.
3. Signs of other severe infections like tuberculosis, sepsis, and meningitis (infection of the protective layers of the brain) should be monitored. If signs of serious infections persist, the treatment should be stopped immediately.
The other signs include:
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Fever.
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Weight loss.
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Sweating.
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Cough.
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Dyspnea or difficulty in breathing.
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Muscle pain and cramps.
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Coughing blood.
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Abdominal discomfort.
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Fatigue and malaise.
4. Although the occurrence of PML (progressive multifocal leukoencephalopathy) is rare, patients should look out for neurological signs. These include progressive weakness on one side of the body and limbs, visual disturbances, impaired memory and thinking, disorientation leading to confusion, and changes in the personality.
Get Regular Blood Tests:
Studies have suggested potential damage to the liver with Vedolizumab treatment. An elevation in the enzymes transaminase and bilirubin is suggestive of liver damage. Hence, it is essential to look for signs of liver damage.
Avoid Self-Medication:
Vedolizumab should never be self-administered. Patients must be registered in a particular program where physicians evaluate the patient’s condition before starting the treatment. Patients enrolled for the treatment should give a thorough medical history prior to the treatment.
The Recommended Diet for Patients on Vedolizumab:
Most patients can continue with a normal routine diet unless the doctor advises otherwise. However, it is essential to eat a nutritious diet. Foods rich in iron, folic acid, and other vitamins like nuts, grains, fruits, and vegetables are recommended. Food items rich in omega fatty acids can be consumed as it reduces inflammation.
Staying on Vedolizumab
Tips to Stay on Track: The remission of symptoms can take up to weeks. The doctor may stop the treatment if the condition has not improved even after 14 weeks of Vedolizumab treatment. It is important to monitor the intensity of symptoms during the treatment. If any adverse effects are seen, they should be reported to the doctor. Following the dosing schedule as recommended by the physician is important.
Things to keep in mind,
1. Missing or forgetting to take the scheduled dose may interfere with the recovery. Contact your doctor to schedule the subsequent dosing.
2. Keep track of your symptoms and regularly follow up with your physician.
For Doctors
Indication:
Currently, Vedolizumab is approved for the treatment of ulcerative colitis and Crohn’s disease. These conditions are characterized by inflammation of the gut mucosa. Vedolizumab acts by targeting specific proteins and immune cells. Studies have shown clinical remission of the studies after Vedolizumab treatment.
Pharmacology:
Mechanism of Action:
Vedolizumab is an artificial monoclonal antibody that blocks the interaction of α4β7 integrin with mucosal addressin cell adhesion molecule-1 (MAdCAM-1) by specifically binding to the α4β7 integrin. It also stops and inhibits the migration of memory T-lymphocytes across the endothelium of the inflamed gastrointestinal parenchymal tissue. The function of α4β1 and αEβ7 integrins are not hindered by Vedolizumab. It does not bind to the integrins and does not counteract the interaction between α4 integrins with vascular cell adhesion molecule-1 (VCAM-1). The surface of a different subset of memory T-lymphocytes also expresses α4β7 integrin on its surface that preferentially migrates into the intestinal mucosa. MAdCAM-1 is mainly present on the intestinal mucosal endothelial cells and plays a crucial role in recruiting T-lymphocytes to gut lymph tissue. A characteristic feature of ulcerative colitis and Crohn’s disease is the interaction of the α4β7 molecule with MAdCAM-1. This interaction has been an essential contributor to chronic inflammation.
Pharmacodynamics:
Vedolizumab doses were given around 0.2 to 10 mg/kg in clinical trials (including doses above the recommended dose), and the α4β7 receptors on subsets of circulating lymphocytes associated with the intestinal immune system were saturated. At amounts ranging from 0.2 to 10 mg/kg and 180 to 750 mg (including doses above the recommended dose) in healthy subjects and patients with ulcerative colitis or Crohn’s disease, Vedolizumab did not increase other white blood cells like neutrophils, basophils, eosinophils, monocytes or natural killer cells. Inflammation in the gastrointestinal system was significantly reduced and was observed in rectal biopsy specimens from phase 2 patients with ulcerative colitis. These patients were exposed to Vedolizumab for four or six weeks compared to placebo control as assessed by histopathology. Additionally, Vedolizumab did not cause alterations in the CD4+ lymphocyte cell counts, CD8+ lymphocyte cell counts, or the CD4+:CD8+ ratios.
Absorption:
Metabolism:
Vedolizumab is thought to be metabolized by proteolytic degradation into smaller protein peptides, individual amino acids, and receptor-mediated clearance.
Elimination:
The expected consequence of metabolism is proteolytic degradation to small peptides and individual amino acids, and Vedolizumab serum concentration is gradually reduced owing to the presence of persistent anti-vedolizumab antibodies. Vedolizumab was either undetectable or at negligible levels from 6 to 52 weeks. The clearance of Vedolizumab depends on linear and nonlinear pathways. The drug clearance with nonlinear pathways decreases with increasing drug concentrations. The serum half-life was 25 days at the dosage of 300 mg with the linear clearance pathway at the rate of 0.157 liters/day. Even after five weeks of intravenous administration, Vedoizumab was not detected in the cerebrospinal fluid (CSF).
Warning and Precaution:
1. Hypersensitivity and Infusion-Related Reactions:
While starting Vedolizumab infusion, ensure to look for the signs of allergic reactions. More than 3 % to 4 % of the patients in clinical trials experienced allergic reaction symptoms. These included difficulty breathing, flushing, rash, urticaria, increased blood pressure and heart rate, constriction of the bronchus, etc. If an anaphylaxis reaction occurs, ensure that the infusion is stopped immediately and start appropriate antihistamine and epinephrine administration.
2. Risk of Developing Infections:
Avoid prescribing Vedolizumab in patients with pre-existing active infections unless the infections are under control. Patients treated with Vedolizumab are at an increased risk of developing infections involving the upper respiratory tract and nasal mucosa. Severe conditions like tuberculosis, sepsis, anal abscess, meningitis, and colon infections have a chance of occurrence. However, the rate of infections was 0.85 per patient-year in the patients treated with Vedolizumab. Ensure to pre-screen the patients for tuberculosis before starting the treatment. Vedolizumab can be started after taking the necessary precautions for patients likely to develop an infection.
3. Progressive Multifocal Leukoencephalopathy (PML):
Patients undergoing Vedolizumab treatment should be monitored and screened for progressive multifocal leukoencephalopathy with regular screening for unexplained neurologic symptoms. Although it is extremely rare, the risk of PML cannot be ruled out. PML signs and symptoms include weakness in the body and limbs, visual disturbances, impaired thinking, disorientation, memory loss, confusion, and personality changes. Discontinue the treatment with Vedolizumab immediately and refer the patient for further neurologic evaluation if PML is suspected.
4. Liver Injury:
In less than 2 % of the patients, the liver enzymes (transaminase and bilirubin) were elevated. They are generally recognized as significant markers of severe liver injury, the elevation of transaminase, and bilirubin in patients receiving Vedolizumab. Stop Vedolizumab treatment in patients with jaundice or other evidence of significant liver injury.
5. Live and Oral Vaccines:
Before initiating treatment with Vedolizumab, ensure to immunize all the patients according to current immunization guidelines. Patients receiving Vedolizumab can receive non-live vaccines (e.g., influenza vaccine injection) and live vaccines after assessing the benefits and risks. There is no evidence of secondary infection by live vaccines in patients receiving Vedolizumab.
6. Risk of Cancer:
0.4 % of patients reported malignancies, including colon cancer, breast cancer, and squamous cell carcinoma. Although the long-term cancer exposure risk was limited, a regular follow-up and regular screening will reduce the risk.
Indications and Uses:
1. Adult Ulcerative Colitis and Adult Crohn's Disease
Recommended for patients not responding to corticosteroid therapy or other drug therapies.
Dosage and Administration:
Vedolizumab should be administered as an intravenous infusion over 30 minutes. It should not be administered as an intravenous push or bolus. Vedolizumab powder must be reconstituted with diluted 250 ml of sterile 0.9 % Sodium chloride injection and sterile water before administration. After completing infusion, flush with 30 ml of sterile 0.9 % Sodium chloride injection. Observe patients during infusion and until the infusion is complete.
Reconstitution and Dilution Instructions:
Reconstitute Vedolizumab at room temperature using an aseptic technique.
1. Reconstitute Vedolizumab vial containing lyophilized powder with 4.8 ml sterile water for injection, using a 21 to 25 gauge syringe, removing the flip-off cap.
2. The syringe needle must be inserted through the center of the stopper so that the sterile water stream can be directed to the glass wall of the vial so that no excessive foaming occurs.
3. To dissolve the lyophilized powder, gently swirl the vial for at least 15 seconds. Avoid vigorous shaking or inversion.
4. You can allow the solution to sit at room temperature for up to 20 minutes to reconstitute and allow any foam to settle. You can swirl and examine the dissolution solution. If it has not yet dissolved, allow another 10 minutes.The vial should not be used if the drug product has not dissolved within 30 minutes.
5. Vedolizumab solution should be clear or opalescent, colorless to light brownish yellow, and free of visible particulates before administration. Testing for particulate matter and discoloration should be conducted before administration.Reconstituted solutions that are uncharacteristic or contain particles should not be administered.
6. Invert the Vedolizumab reconstituted solution three times before withdrawing 5 ml (300 mg) with the syringe and a needle that measures 21 to 25 gauges. Discard any remaining liquid.
Dilution Instructions:
To the 250 ml of 0.9% Sodium chloride infusion set, mix the prepared infusion solution with 5 ml of reconstituted Vedolizumab solution (300 mg). Do not add any other medicines to the infusion solution. Once the infusion solution has been reconstituted and diluted, use it immediately. Store it between 2 to 8 degrees Celsius if the solution must be stored. If the solution is not to be used within four hours, discard it.
Drug Interactions:
1. Vedolizumab should not be used concomitantly with Natalizumab due to the potential for increased infection risk.
2. Vedolizumab should not be used along with TNF blockers due to risks of infection.
3. Vedolizumab can be administered in conjunction with live vaccines as long as the benefits outweigh the risks.
Use in Specific Populations:
1. Pregnancy: Vedolizumab exposure during pregnancy is monitored by a registry that monitors pregnancy outcomes. Pregnant women have not been studied with Vedolizumab. In animal reproduction studies involving rabbits and monkeys treated with vedolizumab, doses twenty times higher than the recommended human dose, no fetal harm was observed. Vedolizumab is likely to cause more adverse pregnancy effects during the second and third trimesters. When a pregnancy progresses, monoclonal antibodies linearly cross the placenta, with the most antibodies being transferred during the third trimester. Single intravenous doses of 100 mg/kg given on gestation day 7 of pregnant rabbits resulted in a reproduction study (about 20 times the recommended human dose). According to the survey, Vedolizumab does not impair fertility or harm the fetus. Monkeys receiving doses of up to 100 mg/kg intravenously (about 20 times the recommended human dose) showed no adverse effects on pre-and postnatal development.
2. Nursing Mothers: Vedolizumab is not present in human milk. According to trials, lactating monkeys have been found to have Vedolizumab in their milk. Vedolizumab should be administered with caution to nursing mothers.
3. Pediatric Use: Vedolizumab is not proven safe or effective in pediatric patients. Overall safety or effectiveness was observed between these patients and younger patients, and there were no differences in elderly and younger patients according to other reported clinical experiences.
4. Geriatric: the clinical trials of Vedolizumab did not include sufficient numbers of geriatric subjects aged 65 and over to determine the response. No difference in the overall safety or effectiveness was observed between geriatric and younger patients.
