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| |  Benefits of Infliximab-Azathioprine Sustained at 1 Year in Patients With Crohn's Disease: Presented at GASTRO 2009 (UEGW/WCOG) By Sara Freeman LONDON -- November 30, 2009 -- Patients with moderate-to-severe Crohn’s disease are more likely to achieve long-term, steroid-free remission if they are treated with infliximab (IFX), either alone or in combination with azathioprine (AZA), than if they are treated with AZA alone, according to data from the SONIC extension study. The phase 3b findings were reported here November 25 at GASTRO 2009. After 50 weeks of treatment, clinical steroid-free remission, defined as a Crohn’s disease activity index (CDAI) score of <150, was observed in 46.2% of patients treated with the combination (P < .001 vs AZA; P = .035 vs IFX), in 34.9% treated with IFX alone (P = .028 vs AZA), and in 24.1% of those treated with AZA alone. These findings build on those already seen at 26 weeks, where the percentage of patients in steroid-free remission was 56.8% in the IFX-AZA group, 44.4% in the IFX group, and 30.0% in the AZA group. “Patients with clear evidence of active inflammation had a particularly strong benefit from an infliximab-based regimen,” said Jean-Frédéric Colombel, MD, University of Lille, Lille, France. Indeed, the 50.0% of patients with high (>=0.8 mg/dL) C-reactive protein levels and endoscopic lesions at baseline in the IFX-AZA treatment group achieved steroid-free clinical remission at week 50 (P = .002 vs AZA) compared with 41.5% of patients treated with IFX (P = .016 vs AZA) and 22.7% of those treated with AZA alone. The SONIC extension study involved 280 patients, 55% (N = 508) of the original study population, who had been randomised to 1 of 3 treatment groups and continued blinded treatment for 50 weeks: IFX (5 mg/kg) infusions plus AZA (2.5 mg/kg) capsules (n = 169); IFX plus placebo capsules (n = 169); and AZA capsules plus placebo infusions (n = 170). IFX was administered on weeks 0, 2, 6, and every 8 weeks thereafter. Final efficacy assessments were collected at week 50 in 108, 97, and 75 patients, respectively. There were no undue safety concerns, with a similar percentage of patients reporting >=1 adverse events (AEs): 89.9% (n = 161) in the IFX-AZA group, 89.0% (n = 145) in the IFX group, and 89.4% (n = 144) in the AZA group. Serious AEs occurred in fewer (15.1%) patients given the combination of IFX and AZA than IFX alone (23.9%) or AZA (26.7%). Serious infections occurred in 3.9%, 4.9%, and 5.6% of patients, respectively. Importantly, “no new opportunistic infections, malignancies, or deaths occurred during the study extension,” said Dr. Colombel. “Most of the SONIC patients enrolling in the extension were in steroid-free remission at week 50,” Dr. Colombel noted, making this a highly selected “responder” population. Furthermore, more patients taking IFX in combination with AZA than AZA alone were more likely to be in steroid-free clinical remission on entry into the long-term blinded follow-up phase of the study. Nevertheless, the results show a similar safety profile and consistent results with those obtained at the end of the main trial, Dr. Colombel said. Funding for this study was provided by Centocor. GASTRO 2009 is jointly organised by The United European Gastroenterology Federation (UEGF), the World Gastroenterology Organisation (WGO), the World Organisation of Digestive Endoscopy (OMED), and the British Society of Gastroenterology (BSG). [Presentation title: One-Year Data From the SONIC Study: A Randomized, Double-Blind Trial Comparing Infliximab and Infliximab Plus Azathioprine to Azathioprine in Patients With Crohn’s Disease Naïve to Immunomodulators and Biologic Therapy. Abstract OP0323]
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