| Frequently asked questions | Immunomodulator Azathioprine (Imuran, Azasan); 6-MP (Purinethol), methotrexate | Anti-TNF Infliximab (Remicade); adalimumab (Humira); certolizumab pegol (Cimzia) | Combination therapy Immunomodulator plus anti-TNF |
| What type of medication is this? | An immunomodulator is a medicine that is taken to regulate or quiet down the immune system, which then decreases inflammation. | An anti-TNF drug blocks one specific chemical (TNF) in the body. Blocking TNF regulates or quiets down the immune system, which then decreases inflammation. | Using an immunomodulator and an anti-TNF drug together. |
| How is this treatment administered? | Daily, as a pill (azathioprine or 6-MP), or weekly, as a pill or shot (methotrexate). It may take weeks to months to be fully effective, so your doctor may prescribe a steroid, such as prednisone, to start. | Infliximab is given intravenously (injected into the vein) 3 times in the first 6 weeks, then every 6 to 8 weeks. Adalimumab is given subcutaneously (injected under the skin) every other week, and certolizumab is given subcutaneously monthly. These medications act faster than immunomodulators, so you likely won't need steroids. | Daily pill (or weekly shots if methotrexate) PLUS injections either intravenous (into the vein) or subcutaneous (under the skin). |
| After 6 months of treatment, how many people get relief of their symptoms and don't need steroids (eg, prednisone)? | There are no research studies in children directly comparing immunomodulators to anti-TNF drugs to combination therapy. But, we do have good estimates based on research in children and adults for each of these options. | ||
| Approximately 40 people out of 100 (40%). | Approximately 55 people out of 100 (55%). | Approximately 60 people out of 100 (60%). | |
| What are some common, but short-lasting, side effects? | Approximately 3 people out of 100 (3%) develop pancreatitis, where the pancreas becomes inflamed and painful. Other short-term side-effects may include nausea, fever, fatigue, lowering of the white blood cell count, or increase in liver tests. | Allergic reactions like a rash or shortness of breath from an infusion, or pain or swelling at the injection site can occur. | With combination therapy, it's possible to get side effects from both immunomodulators and anti-TNF drugs. |
| How common are serious infections? | Approximately 3 to 6% (between 3 to 6 people out of 100) experience serious infections for each treatment option. | ||
| How many people stop taking the medication because of side effects? | Approximately 10 out of 100 (10%). | Approximately 6 to 7 people out of 100 (6 to 7%). | If side effects occur, it might be possible to stop 1 of the medications and continue the other. |
| What is the risk of getting lymphoma (lymph node cancer)? | Approximately 4 people out of 10,000 (0.04%) for azathioprine and 6-MP. It is not clear if methotrexate has any risk of lymphoma, but not enough research has been done to prove this. | It is not clear that anti-TNF therapy on its own increases the risk of lymphoma at all, but not enough research has been done to prove this. | There does not seem to be a meaningful increase in the risk of lymphoma if adding an anti-TNF to an immunomodulator. The risk is approximately 4 people out of 10,000 (0.04%). |
| What else should I know about the risks of cancer? | A rarer form of cancer is hepatosplenic T cell lymphoma. We don't know exactly how often it occurs, but it is very rare (less often than the type of lymphoma described above). It is seen mostly in young males. It is usually not treatable. This lymphoma has occurred in people taking 6-MP or azathioprine by itself, or as combination therapy with an anti-TNF drug. There have not been cases reported in Crohn disease with either methotrexate or anti-TNF therapy on its own. | ||
| What is the risk of getting lymphoma if not taking these medications? | The risk of developing lymphoma in the general pediatric population is 0.0058%. This is equal to approximately 0.58 per 10,000 or 5 to 6 people out of 100,000. | ||
