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Crohn's Disease: The Benefit of Combined Therapy with Infliximab and Azathioprine

Kurt J. Isselbacher
AccessMedicine from McGraw-Hill © 2010 The McGraw-Hill Companies

Crohn’s Disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract with relapsing and remitting episodes. It is a disease that progresses over time, leading to complications such as strictures, fistulas, or abscesses. Symptoms of mild to moderate disease are treated with mesalamine, budesonide, or systemic glucocorticoids. However, the benefit of glucocorticoids is often offset by the side effects of prolonged exposure. Azathioprine is frequently prescribed for patients in whom first-line therapies fail, especially for those who are dependent on or do not have a response to systemic glucocorticoids; in general 40% of patients treated with azathioprine remain in remission at 1 year. Infliximab and other monoclonal antibodies that target tumor necrosis factor (TNF) have shown effectiveness in inducing as well as maintaining remission in patients with CD. Current treatment guidelines generally recommend initiating treatment with first-line agents (such as mesalamine and systemic glucocorticoids) followed by azathioprine, with anti-TNF therapies reserved for patients in whom conventional therapies have failed.

Colombel and colleagues (2010) have carried out a randomized, double-blind trial to evaluate the efficacy of infliximab monotherapy, azathioprine monotherapy, and a combination of the two drugs in 508 adults with moderate to severe Crohn’s Disease. These patients had not undergone previous immunosuppressive or biologic therapy. Patients were randomly assigned into three groups: (1) those who received IV infusions of 5 mg/kg of infliximab at weeks 0, 2, and 6, and then every 8 weeks plus daily oral placebo capsules; (2) patients receiving 2.5 mg/kg of oral azathioprine daily plus a placebo infliximab infusion; or (3) a combination of the two drugs. Patients received treatment for 30 weeks and then continued in a blind study extension through 50 weeks.

The results of the study showed that CD patients receiving combined therapy had significantly higher rates of glucocorticoid-free clinical remission and mucosal healing than did patients in the other two groups. The overall incidence of adverse effects was similar in the three groups. It is noteworthy that serious infections (including tuberculosis) developed in 3.9% of patients in the combination group, 4.9% in the infliximab group, and 5.6% in the azathioprine group. While previous data suggested that combinations of azathioprine and anti-TNF agents increased the relative risk of serious infections, the data in this study did not corroborate those previous findings—and, as noted, combination therapy had fewer side effects than infliximab monotherapy.

This study shows that the combination of infliximab plus azathioprine treatment resulted in significantly higher rates of steroid-free clinical remission in patients with moderate to severe Crohn’s Disease than in patients receiving either agent alone.
Thanks for the post - I find out tomorrow if Infliximab is being added to my drug list and I'm actually kinda nervous!
Thanks for the post - I find out tomorrow if Infliximab is being added to my drug list and I'm actually kinda nervous!
There's a lot of info here on the drug, my other post yesterday (Patient Outcomes after Anti-TNF-α Drugs for Crohn's Disease) is a good lit review on this class of drugs.

Glad you find the posts helpful ;)