Faces of Bio-Naïve The Bio-Skeptic (CD)
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Adults with moderately to severely active CD

I can manage*

*And by “manage,” I mean my Crohn’s symptoms are not under control, but I’m wary of unfamiliar treatments

Have you encountered this patient before?

Meet the Bio-Skeptic

Signs of a Bio-Skeptic

  • Is your patient currently experiencing CD-related symptoms but remains hesitant to try your recommendation of a biologic?7
  • Does your patient have a history of being offered biologics but still refrains from considering them as a treatment option?7
  • Has your patient ever communicated their reasons behind their resistance to try a biologic, such as cost concerns, safety risks, mode of administration, concern the treatment isn’t efficacious, etc?7

What Does the Data Say?

Based on an analysis of social media sites and e-Forums, over half of the posts focused on negative experiences and concerns with biologics7 55% Social media posts focused on negative experiences and concerns with biologics7

And in another analysis of survey data, nearly 4 out of 5 patients reported no knowledge regarding the safety profile of biologics8 79% Patients reported no knowledge of biologic safety profile8

Data based on an analysis of 1598 IBD-related posts from over 3000 social media sites and e-Forums posted between 2012 and 2015; 452 posts discussed the risks and benefits of biologics in IBD treatment. Of the random sample of 15,701 that were examined, 8453 mentioned biologic medications.

Data based on a 2009 survey conducted in Ireland where the attitudes and knowledge of 100 IBD patients (44 UC, 56 CD) were assessed through the use of a questionnaire regarding the safety profile of IBD treatments. Responses were collected from patients visiting a gastroenterology clinic at a teaching hospital. Of the 100 IBD patients surveyed, 17 patients reported taking biologic medications.

With the increasing number of biologic therapies available to those with IBD, it is becoming more complex for patients to weigh the risks and benefits when deciding to initiate, change, continue, or discontinue biologics.”

- Martinez et al. 2017

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.