Adults with moderately to severely active UC
My symptoms are under control*
*And by “under control,” I mean that as long as I
keep taking steroids, I feel okay—but every time I
stop, my symptoms come back
Have you seen this UC patient before?
Meet the Troubled Taperer
Signs of a Troubled Taperer
A Troubled Taperer is someone who is steroid dependent. This can be assessed by answering 'yes' to either of the following questions:
- After steroid treatment was discontinued, did the patient’s UC symptoms return?3
- Does tapering steroid doses also cause the patient’s UC symptoms to return?3
What Does the Data Say?
In a population-based analysis, almost 3 out of 4 UC patients were identified as steroid dependent prior to anti-TNF initiation4† 72% Patients who were steroid dependent prior to anti-TNF initiation4†
9% of UC patients received an anti-TNF treatment within 1 year of the initial episode of becoming steroid dependent4† 9% Steroid dependent patients who received an anti-TNF treatment within 1 year of initial corticosteroid dependence episode
†Data based on a population-based analysis where UC patients, identified from the University of Manitoba IBD Epidemiology Database, who received anti-TNF therapy between 2001 and 2014 (N=229) were assessed for patterns of prior use of corticosteroids.
Dependency on corticosteroids is often encountered in patients with inflammatory bowel disease. In many cases, the dose of corticosteroids cannot be tapered without an increase in disease activity.”5
- Hanauer 2016
Important Safety Information
- ENTYVIO (vedolizumab) for injection is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients.
- Infusion-related reactions and hypersensitivity reactions including anaphylaxis have occurred. Allergic reactions including dyspnea, bronchospasm, urticaria, flushing, rash, and increased blood pressure and heart rate have also been observed. If anaphylaxis or other serious allergic reactions occur, discontinue administration of ENTYVIO immediately and initiate appropriate treatment.
- 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.
- Although no cases of PML have been observed in ENTYVIO clinical trials, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death has occurred in patients treated with another integrin receptor antagonist. A risk of PML cannot be ruled out. Monitor patients for any new or worsening neurological signs or symptoms. Typical signs and symptoms associated with PML are diverse, progress over days to weeks, and 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 a neurologist; if confirmed, discontinue ENTYVIO dosing permanently.
- 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.
- 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.
- Most common adverse reactions (incidence ≥3% and ≥1% higher than placebo): nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritus, sinusitis, oropharyngeal pain, and pain in extremities.
Adult Ulcerative Colitis (UC)
ENTYVIO (vedolizumab) is indicated in 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 for inducing and maintaining clinical response, inducing and maintaining clinical remission, improving endoscopic appearance of the mucosa, and achieving corticosteroid-free remission.
Adult Crohn’s Disease (CD)
ENTYVIO (vedolizumab) is indicated in 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, and achieving corticosteroid-free remission.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. Am J Gastroenterol. 2019;114(3):384-413.
- Rubin DT, Siegel CA, Kane SV, et al. Inflamm Bowel Dis. 2009;15(4):581-588.
- Faubion W, Loftus E, Harmsen W, et al. Gastroenterology. 2001;121:255-260.
- Targownik LE, Tennakoon A, Leung S, et al. Clin Gastroenterol Hepatol. 2017;15(7):1061-1070.
- Hanauer SB. N Engl J Med. 1996;334(13):841-848.
- Ho G-T, Chiam P, Drummond H, et al. Aliment Pharmacol Ther. 2016;24:319-330.
- Martinez B, Dailey F, Almario CV, et al. Inflamm Bowel Dis. 2017;23(7):1057-1064.
- Cullen G, Donnellan F, Long S, et al. Scand J Gastroenterol. 2010;45(9):1076-1083.