Adalimumab, Certolizumab Pegol and Infliximab
Certolizumab Pegol (Cimzia®)
What do these medications do?
Patients with Crohn's disease and ulcerative colitis sometimes require treatment with a group of medications called
anti-tumor necrosis factor antibodies (anti TNF antibodies for short). Anti-TNF antibodies are usually used when you no longer respond to or develop side effects to other medications including aminosalycilates (5-ASA's), steroids (prednisone), immunomodulators (mercaptopurine/6MP/Azathioprine/Imuran). However, in some cases they are being used earlier in the disease.
Anti-TNF antibodies work by blocking inflammatory chemicals in the blood, and may also decrease the number of immune cells in the body.
Remicade (infliximab) has been used since 1998 for the treatment of moderate to severe Crohn's disease. It is also used to treat ulcerative colitis and fistulizing Crohn's disease.
Humira (adalimumab) has been used for the treatment of Crohn's disease in adults since 2007, and since 2003, for the treatment of patients with rheumatoid arthritis. The most recent anti-TNF medication approved in 2008 by the FDA, for patients with Crohn's disease is
How effective are the Anti-TNF therapies?
The medications appear to be equally effective. Approximately 66% (2 out of 3) patients with Crohn's disease will respond within the first two doses, and approximately 30-50% of those patients, will maintain response for up to one year. If you are well at 1 year, you are likely to remain well, with approximately 10% (1 out of 10) of patients coming off of drug each year due to loss of effect or side effects. Approximately 30-50% (1/3-1/2) of patients will require a change in dose or interval of drug administration at some time during the course of therapy.
How are the medications given?
Remicade® is given as an intravenous infusion over 2 hours. You will receive the initial infusions at 0, 2 and 6 weeks, and every 8 weeks thereafter. You will get the infusion in the Pheresis (infusion) unit here at the Beth Israel Deaconess Medical Center, and it is very important to adhere to the prescribed time schedule. The telephone number of the Pheresis unit is (617)-667-1522.
Humira® is given as self administered subcutaneous injections that come in a prefilled penlike syringe. On day 1 you take 4 injections, on day 15 you take 2 injections, and every other week thereafter, you take 1 injection. If you choose Humira, you will be asked to come in for an injection teaching session. The most common complaint is some stinging for several minutes following the injection. This can be minimized by icing the area for 3-5 minutes prior to injecting, and removing the pen from the refrigerator 20-30 minutes prior to the injection.
Cimzia® is given as monthly subcutaneous injections. It comes in two vials that can either be reconstituted to form a solution, which are given by a nurse, or in a prefilled syringe that you can self inject. The company that makes the medication has nurses who will come to your home for the monthly injections.
These are safe medications, however, there are rare side effects, which include:
Infection. In general, you will be slightly more susceptible to infection than the general population because you will be receiving medication that alters your immune system. Tuberculosis (TB), has been reported in less than 1% of patients receiving ant-TNF medications. You will be asked to have a TB skin test and quite likely a chest x-ray prior starting Remicade, Humira, or Cimzia. Please let us know if you have had exposure to TB. In addition, you should be tested for previous exposure to Heptatitis B. If you have not been exposed to Hepatitis B and have not been vaccinated, we recommend vaccination. You will also need to let us know if you have any signs or symptoms of infection, including fever, chills, swollen glands, cough, night sweats, weight loss.
Lymphoma. There is a rare, but reported risk of lymphoma (a tumor of the lymph glands) in patients receiving anti-TNF therapy. There is likely a slight increase in risk over the general population. There have also been 19 cases of a rare but fatal lymphoma on patients taking both infliximab (Remicade) and 6MP/Azathioprine, and there are now 4 reports of this rare lymphoma occurring in patients taking both Humira (adalimumab) and 6MP/Azathioprine.
Infusion reactions. Patients may develop antibodies to Remicade (infliximab). If this happens, you may develop an infusion reaction which can consist of flu like symptoms, shortness of breath, chest pain, rashes, or fever. These are usually mild and can be treated with intravenous fluids, acetaminophen (Tylenol), antihistamines, and if needed, steroids.
Injection site reactions. Fewer than 3 % (3 out of 100) patients taking Cimzia, and 8%-20% (8-20 out of 100) of patients taking Humira, may notice some localized redness, tenderness, and mild swelling for few to several days. You will need to notify us if you develop increased pain at injection site, drainage around the injection site, fevers, or chills.
Abnormal liver function tests. Although this is rare, we will monitor your blood tests about every 3 months while you are on the medication.
There are rare risks of developing multiple sclerosis (nerve disorder), a Lupus - like reaction (autoimmune), and congestive heart failure (CHF). Please notify us if you have any numbness or tingling, changes of sensation, rash, or any unusual symptoms.
You should not receive live vaccines (ex. measles mumps & rubella, chicken pox, nasal flu, nasal H1N1, varicella) while taking this medication. Inactivated vaccines (ex. tetanus, pneumonia, influenza, and Gardisil®) are safe and recommended. It is a good idea to call your doctor or nurse before receiving any vaccinations.