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Combination Infliximab Plus Azathioprine for Newly Diagnosed Crohn’s Disease

Crohn's disease is a severe, chronic inflammatory bowel disease. It causes ulcers , and bleeding in the digestive tract and may be caused by an overreaction of the immune system. It occurs in the US at a rate of 5-10 per 1,000 people and can be very disabling. Medical treatments do exist but have many side effects. Common treatments include corticosteroids like prednisone that lower the immune system.

A recent study published in the Lancet offers hope to Crohn’s disease sufferers. The study reviewed the effects that Infliximab (an anti-tumor necrosis factor medication) and azathioprine (suppresses immune system) have against the disease. The drugs were given to patients newly diagnosed with Crohn’s disease before they had received any corticosteroids.

About the Study

The study followed 133 patients that had been diagnosed with Crohn's disease less than 11 weeks before. The patients aged 16-75 years were followed for 2 years. Researchers randomly assigned the patients to 1 of 2 treatment groups. One group, called the control group, received conventional (typical) treatment so that the effects of the new treatment can be compared.

  • Group A: Received the new treatment with 3 infusions of infliximab plus azathioprine. If the new treatment was not helpful after 6 weeks, additional infliximab or corticosteroids were given.
  • Group B: Received conventional therapy which included corticosteroids with increasing doses if symptoms did not respond. Patients were given azathioprine and infliximab if symptoms worsened after corticosteroid use.

The results of this study are promising. Information gathered after 6 months and at one year, showed that those who took the new treatment (infliximab and azathioprine) were significantly less dependent on corticosteroids and were in disease remission.

Often patients with Crohn’s disease undergo endoscopic procedures to monitor disease progress. In this study, 49 patients had an endoscopy after 2 years. Of those with endoscopy results, 73% of those who had taken the study medications had no ulcers, while only 30% of the control group had no ulcers.

How Does This Affect You?

Ask your doctor about treatment options if you have been diagnosed with Crohn’s disease. Decisions about treatment can be confusing. There may now be an option to long-term use of corticosteroids. This study is helpful because it followed the effects of the medication for 2 years. However, the study was also small and did not use a study technique called blinding. Further study of these medications in Crohn’s disease is necessary.




  • D’Haens G, Baert F, van ASsche G, et al. Early combined immunosuppression or conventional management in patients with newly diagnosed Crohn's disease: an open randomised trial. Lancet . 2008 Feb 23;371(9613):660.

Last reviewed March 2008 by Larissa J. Lucas, MD

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