By Karen Dente, MD
HAMBURG, Germany -- February 5, 2009 -- Infliximab as monotherapy or in combination with azathioprine is more effective than azathioprine treatment alone in achieving clinical remission in patients with Crohn's disease, according to study results presented here at the 4th Congress of the European Crohn's and Colitis Organisation (ECCO-IBD).
"The primary objective of our study was to assess the induction of steroid-free remission and the safety of infliximab monotherapy and infliximab-plus-azathioprine combination therapy with azathioprine monotherapy in patients with moderate to severe Crohn's disease," reported lead investigator J.F. Colombel, MD, Centre Hospitalier Universitaire de Lille, Lille, France. The results were presented in a poster session on February 5.
A total of 508 patients aged 34 years on average were randomised to double-blind treatment with either azathioprine plus placebo, infliximab plus azathioprine, or infliximab alone. Infliximab was administered by infusion at a dose of 5 mg/kg at week 0, 2, and 6, and then every 8 weeks. Azathioprine was administered orally at a dose of 2.5 mg/kg.
Final assessments were performed at week 26, at which point patients with mucosal ulcerations at baseline underwent endoscopic assessment.
At baseline, 41% of patients were receiving steroids and all patients were naïve to immunomodulators and biologic therapies prior to starting study treatment.
In terms of steroid-free remission, the researchers found that infliximab plus azathioprine was clearly more effective than infliximab alone, the researchers reported.
At week 26, 57% of patients on infliximab plus azathioprine had achieved steroid-free remission compared with 44% of patients receiving infliximab alone (P < .022). Azathioprine monotherapy was the least effective, with 31% of patients in this group achieving steroid-free remission (P < .001).
A subanalysis performed by looking at the number of patients with mucosal healing at week 26 showed that about 44% of patients with double therapy achieved mucosal healing compared with 30% of patients receiving infliximab alone and 17% with azathioprine alone (P < .001 for infliximab-azathioprine vs azathioprine alone).
"This indicates that patients with evidence of active inflammation by [C-reactive protein] or who also had endoscopic lesions at baseline showed a strong benefit from the infliximab-based regimens compared to azathioprine monotherapy," the researchers reported.
In terms of safety, all treatment groups were similar. There was one death as a result of a colectomy in a patient who received azathioprine monotherapy.
"Moderate to severe Crohn's disease patients treated with infliximab monotherapy or infliximab plus azathioprine (when initiated together) are more likely to achieve steroid-free clinical remission and complete mucosal healing than those receiving azathioprine alone," summarised lead investigator Dr. Colombel.
[Presentation title: SONIC: A Randomized, Double-Blind, Controlled Trial Comparing Infliximab and Infliximab Plus Azathioprine to Azathioprine in Patients With Crohn's Disease Naïve to Immunomodulators and Biologic Therapy. Abstract P087]
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