In recent years, there have been significant advances in treating IBD, especially for patients whose IBD does not respond to traditional treatment options.  The most important advance has been the development of a group of medications called biological response modifiers or simply ‘biologics”.  Biologics are isolated from a variety of natural sources – human, animal, or microorganism –  produced by biotechnology methods and other cutting-edge technologies.  In contrast to most drugs that are chemically synthesized, most biologics are complex mixtures.[1]

 

Below is a brief review of the approved biologics used to treat the various forms of IBD: Cimzia, Entyvio, Humira, Remicade, Simponi, Stelara, Tysabri.

 

Brand

Name

 

 

Generic

Name

 

      Indication(s)

 

Cimzia

Certolizumab pegol

  1. Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Entyvio

vedolizumab

  1. Adult Crohn's Disease (CD): 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.
  2. Adult Ulcerative Colitis (UC): 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:

Humira

adalimumab

  1. Adult Crohn’s Disease (CD): Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
  2. Pediatric Crohn’s Disease: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate.
  3. Ulcerative Colitis (UC): Inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

Remicade

infliximab

  1. CD: reducing signs and symptoms and inducing and maintaining clinical remission in adult and pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
  2. Fistulizing CD: reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing disease.
  3. UC: reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult and pediatric patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

Simponi

golimumab

  1. Adult UC: Moderate to severe Ulcerative colitis (UC) with an inadequate response or intolerant to prior treatment or requiring continuous steroid therapy

Stelara

ustekinumab

  1. Adult CD: moderately to severely active Crohn’s disease (CD) who have failed or were intolerant to treatment with immunomodulators or corticosteroids, but never failed a tumor necrosis factor (TNF) blocker or failed or were intolerant to treatment with one or more TNF blockers.

Tysabri

natalizumab

  1. Moderately to severely active CD with evidence of inflammation who have had an inadequate response to, or unable to tolerate, conventional CD therapies and TNF inhibitors.
  2. Restrictions In CD, should not be used in combination with immunosuppressants or TNF inhibitors