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Benefits Beat Risks in Combo Therapy for Crohn’s Disease

Last Updated: December 29, 2011.

 

Complications of combo therapy must reach clinically unrealistic incidence to outweigh benefits

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In Crohn's patients treated for one year in the Study of Biologic and Immunomodulator-Naive Patients With Crohn's Disease, infection would have to occur at a rate of 20 percent or greater, and lymphoma at 3.9 percent or greater, for the risks of combination therapy with infliximab and azathioprine to outweigh the benefits, when compared with infliximab monotherapy, according to research published in the January issue of Clinical Gastroenterology and Hepatology.

THURSDAY, Dec. 29 (HealthDay News) -- In Crohn's patients treated for one year in the Study of Biologic and Immunomodulator-Naive Patients With Crohn's Disease (SONIC), infection would have to occur at a rate of 20 percent or greater, and lymphoma at a rate of 3.9 percent or greater, for the risks of combination therapy with infliximab and azathioprine (IFX/AZA) to outweigh the benefits, when compared with IFX monotherapy, according to research published in the January issue of Clinical Gastroenterology and Hepatology.

Using a constructed decision model, Cory A. Siegel, M.D., of the Dartmouth-Hitchcock Inflammatory Bowel Disease Center in Lebanon, N.H., and colleagues analyzed the risks and benefits of IFX/AZA combination therapy versus monotherapy with IFX for Crohn's disease. Parameters for the model were taken from SONIC. The analysis was performed on patients treated for one year who were naive to both medications at the start of treatment.

The researchers found that the benefits during one year of IFX/AZA combination therapy outweighed the risks, unless 20 percent or more of the population experienced infections or 3.9 percent or more of the population experienced lymphoma. Compared to base-case estimates, these thresholds were five-fold and 65-fold higher, respectively.

"On the basis of data from one year of SONIC, the combination of IFX/AZA was more effective than IFX alone in patients with Crohn's disease who are naive to either drug. For the risks of combination therapy to outweigh the benefits in this time frame, the incidence of serious adverse events would have to be higher than seems clinically realistic," the authors write.

Several authors disclosed financial relationships with pharmaceutical companies, including Abbott, Elan, Centocor, and Merck.

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