Faces of Bio-Naïve The Silent Sufferer (UC)
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Adults with moderately to severely active UC

I'm feeling pretty well*

*And by “pretty well,” I mean that I have come to
accept my symptoms, but I’m trying to manage

Does this UC patient seem familiar?

Meet the Silent Sufferer

Signs of a Silent Sufferer

  • Does your patient state that they have symptoms but they can manage?
  • Despite clinically showing signs and symptoms, does your patient fail to discuss them?1,2
  • Does your patient have a history of responding to conventional therapies but no longer does?1,2

What Does the Data Say?

In one survey, on average, patients only discussed 5 of 8 flares with a physician2†‡ 62% Proportion of flares discussed with HCP2†‡

One-third of patients were sometimes reluctant to discuss their flares with their physicians2†‡ 34% Patients reluctant to discuss flares with HCP2†‡

Data based on the UC: NORMAL survey, which was conducted in 2007 to understand how patients perceive the impact of UC relative to gastroenterologists. It was composed of 2 national internet surveys, one with 451 patients and the other with 300 gastroenterologists. The patients from this survey self-reported the severity of their UC (76% of patients self-reported moderate to severe UC).

“Flare” was not defined and was open to patient interpretation.

A possible reason for discrepancies between patients’ and physicians’ perspectives of the impact of UC may be suboptimal communication.”

- Rubin et al. 2009

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.

Indications

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.

Please see full Prescribing Information, including Medication Guide.

  1. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. Am J Gastroenterol. 2019;114(3):384-413.
  2. Rubin DT, Siegel CA, Kane SV, et al. Inflamm Bowel Dis. 2009;15(4):581-588.
  3. Faubion W, Loftus E, Harmsen W, et al. Gastroenterology. 2001;121:255-260.
  4. Targownik LE, Tennakoon A, Leung S, et al. Clin Gastroenterol Hepatol. 2017;15(7):1061-1070.
  5. Hanauer SB. N Engl J Med. 1996;334(13):841-848.
  6. Ho G-T, Chiam P, Drummond H, et al. Aliment Pharmacol Ther. 2016;24:319-330.
  7. Martinez B, Dailey F, Almario CV, et al. Inflamm Bowel Dis. 2017;23(7):1057-1064.
  8. Cullen G, Donnellan F, Long S, et al. Scand J Gastroenterol. 2010;45(9):1076-1083.

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.

Indications

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.

Please see full Prescribing Information, including Medication Guide.

  1. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. Am J Gastroenterol. 2019;114(3):384-413.
  2. Rubin DT, Siegel CA, Kane SV, et al. Inflamm Bowel Dis. 2009;15(4):581-588.
  3. Faubion W, Loftus E, Harmsen W, et al. Gastroenterology. 2001;121:255-260.
  4. Targownik LE, Tennakoon A, Leung S, et al. Clin Gastroenterol Hepatol. 2017;15(7):1061-1070.
  5. Hanauer SB. N Engl J Med. 1996;334(13):841-848.
  6. Ho G-T, Chiam P, Drummond H, et al. Aliment Pharmacol Ther. 2016;24:319-330.
  7. Martinez B, Dailey F, Almario CV, et al. Inflamm Bowel Dis. 2017;23(7):1057-1064.
  8. Cullen G, Donnellan F, Long S, et al. Scand J Gastroenterol. 2010;45(9):1076-1083.