Adults with Crohn's or UC can be prescribed the ENTYVIO Pen
US-VED-2641v1.0 04/24
PATIENT PROFILES
Do you see patients like these in your practice?
The Mayo Score is used to assess the severity of ulcerative colitis
The Mayo Score consists of 4 factors1:
- Physician Global Assessment
- Endoscopy findings
- Stool frequency
- Rectal bleeding severity
The Mayo Score ranges from 0-12, with higher scores indicating
more severe disease.
Demonstrating an effect on a composite multiple clinical
factor measure does not represent a clear effect on any of the
individual components.
Bio-naïve moderate ulcerative colitis
Devin, 28
Elementary school teacher
At first, Devin thought his symptoms were caused by nerves from starting out in his career, but they got worse over time. Devin shared with his GI that he likes using steroids because he doesn’t have to take them all the time.
Diagnosis:
Moderate ulcerative colitis
Mayo score 8
7 loose stools daily
Rectal bleeding with some stools
Time Since Diagnosis:
6 months
Imaging:
Colonoscopy showed disease-
marked erythema, absent vascular
pattern, friability, erosions.
Treatment History:
Devin is currently on steroids. Other
conventional therapies haven’t
provided relief.
Devin says he’s worried about the side effects of biologics. For patients like Devin, assess how informed they are about advanced therapies* and offer to review their safety profiles.
*Advanced therapies are used after failure of conventional therapies.
Bio-naïve severe ulcerative colitis
Corrine, 40
Accountant
Corrine has been living with ulcerative colitis for a long time and has developed coping strategies to work around her symptoms. Now that she’s working from home, running to the bathroom is more convenient than it used to be, but she’s frustrated that the treatments she has tried so far only work for the short term.
Diagnosis:
Severe ulcerative colitis
Mayo score 11
15 loose stools daily
Rectal bleeding with more
than half of stools
Disease Duration:
10 years
Imaging:
Repeat colonoscopy showed
spontaneous bleeding and
ulceration.
Treatment History:
Did not respond well to
immunosuppressants; recently
completed a course of steroids to
manage a flare.
Corrine wonders if infusions or injections would be a better fit for her. For patients like Corrine, consider asking if they’d prefer to self-administer their treatment or have it administered by a healthcare professional.
Consider which treatment you would
recommend for patients like Devin and
Corrine
The Crohn’s Disease Activity Index (CDAI) score is used to assess the severity of Crohn’s disease
The CDAI consists of 8 factors2:
- Number of liquid stools
- Abdominal pain
- General well-being
- Extra-intestinal complications
- Use of anti-diarrheal
medications - Abdominal mass
- Hematocrit levels
- Body weight
CDAI scores range from 0 to ~600, with higher scores
indicating greater severity.3
Demonstrating an effect on a composite multiple clinical
factor measure does not represent a clear effect on any
of the individual components.
Bio-hesitant moderate Crohn's disease
Tina, 26
Software engineer
At 26, Tina started to experience abdominal pain and frequent bowel movements. She tried to manage her symptoms by eliminating certain foods from her diet, but her symptoms started to progress until she felt she couldn’t ignore them anymore.
Diagnosis:
Moderate Crohn’s disease
CDAI score 250
10 loose stools daily
Moderate abdominal pain
Time Since Diagnosis:
6 months
Type:
Ileocolitis
Imaging:
Colonoscopy revealed deep
inflammatory ulcers in the transverse
colon, sigmoid colon, and ileum.
Treatment History:
Conventional therapy, including 2
rounds of steroids, hasn’t provided
relief.
Tina has expressed concern about safety risks of advanced therapies.†
†Advanced therapies are used after failure of conventional therapies.
Steroid-dependent, bio-naïve moderate Crohn's disease
Mark, 22
Waiter
Mark has a fast-paced job in a busy restaurant, and he’s worried about missing work. He likes that steroids provide him relief.
Diagnosis:
Moderate Crohn’s disease
CDAI score 280
8 loose stools daily
Severe abdominal pain
Below ideal body weight
Disease Duration:
3 years
Type:
Ileitis
Imaging:
CT enterography of terminal ileum
shows irregularity, nodularity, wall
thickening, and narrowed lumen.
Treatment History:
Conventional therapy and anti-
diarrheals have provided partial
relief.
Mark wants a therapy he doesn’t have to take every day.
Consider which treatment you would
recommend for patients like Tina and Mark
Explore more topics
Here to support your patients
Once you prescribe ENTYVIO, EntyvioConnect offers a range of
programs designed to help your patients in the way they need it
most.
Learn about starting and maintaining treatment
What do the experts have to
say?
The content on this page has been written and
reviewed by Takeda.
IMPORTANT SAFETY INFORMATION
Contraindications
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
WARNINGS AND PRECAUTIONS
- Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart
IMPORTANT SAFETY INFORMATION
Contraindications
ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
Warnings and precautions
- Infusion-Related and Hypersensitivity Reactions: Infusion-related reactions and hypersensitivity reactions including anaphylaxis, dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have been reported. These reactions may occur with the first or subsequent infusions and may vary in their time of onset from during infusion or up to several hours post-infusion. If anaphylaxis or other serious infusion-related or hypersensitivity reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
- Infections: Patients treated with ENTYVIO are at increased risk for developing infections. Serious infections have been reported in patients treated with ENTYVIO, including anal abscess, sepsis (some fatal), tuberculosis, salmonella sepsis, Listeria meningitis, giardiasis, and cytomegaloviral colitis. ENTYVIO is not recommended in patients with active, severe infections until the infections are controlled. Consider withholding ENTYVIO in patients who develop a severe infection while on treatment with ENTYVIO. Exercise caution in patients with a history of recurring severe infections. Consider screening for tuberculosis (TB) according to the local practice.
- Progressive Multifocal Leukoencephalopathy (PML): PML, a rare and often fatal opportunistic infection of the central nervous system (CNS), has been reported with systemic immunosuppressants, including another integrin receptor antagonist. PML typically only occurs in patients who are immunocompromised. One case of PML in an ENTYVIO-treated patient with multiple contributory factors has been reported. Although unlikely, a risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms that may include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. If PML is suspected, withhold dosing with ENTYVIO and refer to neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
- Liver Injury: There have been reports of elevations of transaminase and/or bilirubin in patients receiving ENTYVIO. ENTYVIO should be discontinued in patients with jaundice or other evidence of significant liver injury.
- Live and Oral Vaccines: Prior to initiating treatment with ENTYVIO, all patients should be brought up to date with all immunizations according to current immunization guidelines. Patients receiving ENTYVIO may receive non-live vaccines and may receive live vaccines if the benefits outweigh the risks.
Adverse reactions
The most common adverse reactions (incidence ≥3% and ≥1% higher than placebo) were: nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, pain in extremities, and injection site reactions with subcutaneous administration.
Drug interactions
Because of the potential for increased risk of PML and other infections, avoid the concomitant use of ENTYVIO with natalizumab products and with TNF blockers.
INDICATIONS
Adult Ulcerative Colitis (UC):
ENTYVIO is indicated in adults for the treatment of moderately to severely active UC.
Adult Crohn’s Disease (CD):
ENTYVIO is indicated in adults for the treatment of moderately to severely active CD.
Dosage forms & strengths:
- ENTYVIO Intravenous (IV) Infusion: 300 mg vedolizumab
- ENTYVIO Subcutaneous (SC) Injection: 108 mg vedolizumab
Please click for Full Prescribing Information.
References:
- Feagan BG, Rutgeerts P, Sands BE, et al; for the GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699-710 (study protocol).
- Sandborn WJ, Feagan BG, Rutgeerts P, et al; for the GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711-721 (study protocol).
- Sandborn WJ, Feagan BG, Rutgeerts P, et al; for the GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711-721.
