Biologics

  • what are biologics?
    • these are medications that are designed to specifically target a protein or a pathway of the inflammatory and immune responses
    • currently the approved biologics include antibodies (proteins that bind to other proteins) that block certain inflammatory pathways that are thought to lead to IBD
  • which biologics are out there?
    • there are 3 categories of biologics – they all work by binding and blocking the effect of a protein
    • anti-tumour necrosis factor-alpha (anti TNF-a) – infliximab (Remicade, Inflectra), adalimumab (Humira), golimumab (Simponi)
      • TNF is a cytokine that causes inflammation
      • anti TNF drugs bind to TNF and block its inflammatory effects
    • anti-interleukin (anti IL12/23) – ustekinumab (Stelara)
      • IL-12/23 cytokines cause inflammation when they bind to their receptors
      • ustekinumab blocks this binding to the receptors and thus stops/reduces inflammation caused by IL-12/23 cytokines
    • anti-integrin (anti-a4b7 ) – vedolizumab (Entyvio)
      • a4b7 are proteins found on white blood cells. MAdCAM1 are proteins found on the gut blood vessel walls.  IN order for the white blood cells to enter the gut tissue, their a4b7 protein has to bind to the MAdCAM1 proteins.
      • vedolizumab blocks the binding of a4b7 to MAdCAM1 thus blocking the white blood cells from going into the gut (blocks leukocyte or white blood cell trafficking)
  • how are these given?
    • these are given by intravenous infusions (IV), subcutaneous (just under the skin) injections (SC), or a combination of IV and SC
    • induction: these drugs require an induction period (meaning more frequent and higher doses of drugs at the beginning) in order to get the “drug level” high enough
    • maintenance: once you have the first induction doses, if the drug works, you will be kept on a schedule of every 1, 2, 3, 4 or more weeks depending on response to the drug and type of drug.  It is very important not to skip or be late for doses, otherwise you can develop antibodies (proteins that block the drug) and lose the effect of the drug
  • what is a drug level?
    • drug level refers to the amount of the drug in your blood – scientists and clinicians have studied the range of drug level that controls inflammation.
    • Individual people and different diseases types may require differnt minimum drug levels to get into and stay in remission.
  • what is an antibody level?
    • antibody is a protein that blocks something else – so an antibody to the biologic drug is protein your body makes that blocks the drug.
    • This can cause issues such as losing response to the drug, or developing reactions to the drug.
    • Your doctor may prescribe an immunosuppresant such as Imuran or Methotrexate in order to lower the changes of you developing antibodies to the biologic drugs.
    • The chances of you developing an antibody to the drug is higher if you have missed doses or delayed doses.
  • PATIENT INFORMATION – biologics
  • BIOLOGICS – pre biologic start up letter

More on Biologics can be found at:

IBD and Me (A decision aide tool developed by Cedar Sinai clinic jointly sponsored by Takeda)