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| |  Infliximab or Combination With Azathioprine Better in Crohn's Disease Than Azathioprine Alone: Presented at ACG By Ed Susman KISSIMMEE, Fla -- October 8, 2008 -- Patients with Crohn's disease who are naïve to immunomodulating drugs have a better chance of mucosal healing when they are treated with the biologic agent infliximab than with the immunosuppressant azathioprine and are more likely to achieve a corticosteroid-free clinical remission, according to results of the results of the Study of Biologic and Immunomodulator Naïve Patients in Crohn's Disease (SONIC). The results were presented here on October 7 here at the American College of Gastroenterology (ACG) 73rd Annual Scientific Meeting. In the study, significantly more patients treated with infliximab alone or the combination of infliximab and azathioprine had relief of symptoms than patients treated with azathioprine alone. The better outcomes did not come at the expense of additional adverse events, either. "Safety was similar in all 3 arms of the study," said William J. Sandborn, MD, Mayo Clinic, Rochester, Minnesota. "There was no trend toward an increased risk of serious infections with infliximab." In SONIC, researchers enrolled 508 patients, assigning 170 to receive azathioprine 2.5 mg/kg plus placebo infusions every 8 weeks following induction therapy; 169 patients received infliximab 5 mg/kg infusion plus placebo capsules at the same dosing schedule, and 169 patients received infusions of both infliximab 5 mg/kg and azathioprine 2.5 mg/kg. Patients were mainly white men with an average age of 35 years and had lived with Crohn's disease for about 2.3 years. Patients were recruited across Europe, the United States, and Israel. The primary endpoint of the study was corticosteroid-free clinical remission at 26 weeks. Dr. Sandborn said that 30.6% of patients taking azathioprine alone achieved corticosteroid-free clinical remission compared with 44.4% of patients on infliximab monotherapy (P = .009) and 56.8% of patients on combination therapy (P < .001). He suggested that clinicians should consider infliximab alone or in combination with azathioprine when thinking of placing patients on immunomodulating drugs. He also noted that the patients with the highest levels of C-reactive protein and/or with endoscopic evidence of ulcers did better with infliximab alone or with combination therapy. "Patients with high baseline C-reactive protein levels -- 60% of the patients in this study -- and/or ulcers observed at baseline colonoscopy had a particularly strong benefit from early infliximab therapy," he said. In these patients, corticosteroid remission-free survival at 26 weeks was doubled with infliximab monotherapy compared with azathioprine (56.9% vs 28%; P < .001) and 68.8% of patients on combination therapy (P < .001). The difference between infliximab monotherapy and the combination in this subgroup of patients did not reach statistical significance (P = .169). In addition, Dr. Sandborn said that 44% of patients on infliximab combination therapy (P < .001) and 30% receiving infliximab monotherapy (P = .0223) achieved mucosal healing compared with 17% of patients receiving azathioprine alone. Funding for the SONIC study was provided by Centocor.
[Presentation title: SONIC: A Randomized, Double-Blind, Controlled Trial Comparing Infliximab and Infliximab and Azathioprine to Azathioprine in Patients With Crohn's Disease Naïve to Immunomodulators and Biologic Therapy. Abstract 29]
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