Crohn’s Disease Study on Infliximab, Azathioprine

A study led by Mayo Clinic has found that infliximab (Remicade®) administered alone (monotherapy) or in combination with azathioprine is a more effective treatment for patients with moderate to severe Crohn’s disease than azathioprine alone. The findings were presented Oct. 6 at the 2008 American College of Gastroenterology (ACG) Annual Meeting.

Crohn’s disease is an inflammatory disorder of the gastrointestinal tract that affects an estimated 500,000 people in the United States. Symptoms include abdominal pain, fever, nausea, vomiting, weight loss and diarrhea. Crohn’s disease has no known medical cure.

“Historically, patients with Crohn’s disease have been treated sequentially with steroids, then azathioprine, then monoclonal antibodies such as infliximab. The study definitively demonstrates that infliximab-based strategies are more effective than azathioprine,” says William Sandborn, M.D., the lead author and a gastroenterologist at Mayo Clinic. “Clinicians should consider a shift in practice to incorporate this new data.”

The study, conducted at more than 130 sites, included 508 patients who have moderate to severe Crohn’s disease. Researchers found that 57 percent of patients who received combination therapy with infliximab and azathioprine achieved steroid-free remission after 26 weeks. This is compared to 44 percent of patients who achieved remission with infliximab monotherapy and 30 percent with azathioprine alone. Both the infliximab combination therapy and infliximab monotherapy groups were statistically superior to the azathioprine group. In addition, 61 percent of patients who received the combination therapy of infliximab and azathioprine also experienced healing of the bowel demonstrated by colonoscopy (mucosal healing).

Dr. William Sandborn, a Mayo Clinic gastroenterologist and the lead researcher on the study, provides background on the disease and describes the study purpose and findings below.

10 Comments

  1. vanilla
    Posted April 21, 2009 at 6:44 am | Permalink

    I hope know some Things about my medicines Hummera * because nobody In my country *helped me to know I do not know English well But I hope that you will help me in that am from
    Saudi Arabia
    Aboso me please

  2. Amy
    Posted April 22, 2009 at 9:23 am | Permalink

    Hello – someone from our Mayo Clinic International Office will be emailing you with more information.

    The link to that office is:

    http://www.mayoclinic.org/english/appointments.html

    Thank you.

  3. alex arguello
    Posted July 9, 2009 at 10:17 am | Permalink

    I was just wandering when the doctor said that combination of the therapies increases the side effects a little, how is he justifying lymphoma or any type of cancer a a small risk. He also said that they did not find too much toxicity from the drugs through out the trial. The trial was done for 6 months, the people that will be prescribed these drugs will be on them for the rest of their life. How do they know that the toxicity levels will not increase the longer you are on the drugs?

  4. Jeannie R
    Posted July 18, 2009 at 7:48 am | Permalink

    I have had two bowel resections, 6 anal fistulas,perirectal abscess I& D several times, gall bladder removed, uterus and ovaries removed,erthema nodosum in my leg, and sepsis from a pic line which my vein in my arm had to be removed, had to have a thoracenteis to drain the lung, chest tube inserted after sepsis My mother had lymphoma. I am considering taking Remicade since now I have crohn’s in small intestine in the jenjum. Any research done on the chances of me getting lymphoma since my mother had it? I was taking Asacol and now taking Pentasa. After 10 years straight of taking prednisone my bowel perforated which caused the first surgery. I do not want to have a 3rd surgery and am at a lost of what to do. I am scared of taking Remicade or Humira and am at a lost as to what to do. Any comments greatly appreciated.

  5. Alicia T
    Posted July 19, 2009 at 2:24 pm | Permalink

    My husband suffers from Crohn’s disease; he was diagnosed in 2000. He had his first surgery in 1991 (they didn’t know then that he had Crohn’s yet). His second surgery was in 2004. He has been on remicade since 2005. He we are again and he needs more surgery (another fistula). He has lost so much weight; he’s always sick; diareaha all day everyday vomiting, he has bumps that seem like bug bites but aren’t they flare up all the time in different places mostly his face neck and legs. He has something bothering his eye that seems to be the same thing just extra irritating because its on his eye. He often times wakes up realizing that he didn’t make it to the bathroom this has become more frequent. He doesn’t want to eat because of the fear of how it will feel to come out. He is supposed to have surgery soon but we are scared that mabey we he needs to be seen by
    someone- to possibly find something that works better for him. However what role does insurance play in this? He has keystone 65 and is on disability although he is only 30 years old. Please respond I’m worried about this surgery. Thank you Alicia Thompson

  6. Amy Tieder
    Posted July 23, 2009 at 8:21 am | Permalink

    I would recommend you call the Mayo Clinic Inflammatory Bowel Disease Clinic at 507-538-3270 (Minnesota) or visit our web site for more information on appointments: http://www.mayoclinic.org/ibd/

    Thank you.

  7. Therese Besemann
    Posted August 28, 2009 at 11:07 am | Permalink

    My son was diagnosed with Crohn’s. His father is now 54 years old and was diagnosed with Crohn’s at the age of 12. My son is 12. My husband has had almost all his intestines removed when he was in his teens and 20’s, he has approximately 8-inches of small intestines remaining. We live in a small town of about 30,000 in North Dakota. I am very consered about my son’s treatment for the Crohn’s. We have one hospital in town, Trinity. They are not known for quality care. Even though I have dealt with Crohn’s with my husband, he has been in remittance for over 20 years. His condition without intestines is very different from my son’s. What should I do? Should we try to receive help at Mayo in Minnesota? My husband was treated there about five years ago for pancreitis and other complications from his Crohn’s. I need soem advise and information about my son’s diet. Any assistance would be greatly appreciated.

    • Newsletter Editor
      Posted September 14, 2009 at 12:26 pm | Permalink

      The appointment number for Mayo Clinic’s Pediatric Gastroenterology is 507-266-4950.

  8. Jason Miller
    Posted September 8, 2009 at 12:03 pm | Permalink

    My son has Crohns he is 10 years old and was diognosied at the age of 5. He has tried remicade and many other treatments. First he had the 3 dose treatment. Then a year later we tried it again and he started to get a rash around his mouth after starting the second dose. The Dr. immediatly stopped the remicade and said it does not work. We are now facing surgery and I wanted to ask Dr. Sandborn if he knows of any other treatment we could try. My sons Dr. had told us that we have tried everything. He is currently taking Humira 40mg. But his last colonoscopy showed that the inflimation is great and not responding.

    • Newsletter Editor
      Posted September 10, 2009 at 9:45 am | Permalink

      Thank you for your comment on Crohns disease. It has been forwarded for further information.


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