Remicade(R) (Infliximab) Is More Likely To Induce Steroid-Free Remission And Mucosal Healing Compared With Azathioprine

Main Category: Crohn's
Also Included In: GastroIntestinal / Gastroenterology;  Clinical Trials / Drug Trials
Article Date: 21 Oct 2008 - 5:00 PDT

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Data presented today at the United European Gastroenterology Week Congress (UEGW) show that a significantly greater proportion of patients with moderate to severe Crohn's disease experienced steroid-free remission and mucosal healing when receiving Remicade(R) (infliximab), either in combination with azathioprine or as monotherapy, compared to patients receiving azathioprine alone.1

The phase 3b study for Patients with Crohn's Disease (CD) Naïve to Immunomodulators and Biologic Therapy (SONIC) is the first of its kind to compare infliximab, an anti-TNF, with an immunomodulator in patients with moderate to severe Crohn's disease previously failing 5-aminosalicylate (5-ASA) and/or steroids. At week 26, 57 percent of patients receiving infliximab combination therapy and 44 percent of patients receiving infliximab monotherapy achieved steroid-free remission, the primary endpoint of the study, compared with 31 percent of patients receiving azathioprine alone.

"Findings from the SONIC trial have the potential to challenge the treatment protocol for Crohn's disease as these data show that introducing infliximab earlier may result in more patients achieving steroid-free remission and complete mucosal healing," said Dr. Jean-Frederic Colombel, Professor of Hepatogastroenterology, Centre Hospitalier Universitaire Lille, Lille, France and lead investigator. "These data reinforce the efficacy and safety profile of infliximab in the treatment of this chronic inflammatory bowel disease."

The data also showed that a greater proportion of patients with Crohn's disease achieved mucosal healing, a secondary endpoint of the study, when receiving infliximab. At week 26, 44 percent of patients receiving infliximab combination therapy and 30 percent receiving infliximab monotherapy achieved mucosal healing compared with 17 percent of patients receiving azathioprine alone.1

The prevalence of Crohn's disease in the UK is estimated to be about 50-100 per 100,000 people, it affects approximately 60,000 people in the UK.2 Crohn's disease is a chronic inflammatory disease of the colon and large intestine. It can lead to frequent hospitalisations, surgery and loss of work productivity.2

About Crohn's Disease

Crohn's disease is a chronic inflammatory bowel disorder that commonly affects the lower part of the small intestine and the large intestine and typically begins in late childhood or early adulthood. The disease causes inflammation of the gastrointestinal tract, typically resulting in symptoms such as diarrhoea, fever, abdominal pain and weight loss.2

About SONIC

SONIC is a multicenter, Phase 3b, randomized, double-blind, controlled clinical trial designed to compare the efficacy and safety of infliximab monotherapy, azathioprine monotherapy and combination therapy with the two drugs in patients with moderate to severe Crohn's disease who were naïve to immunomodulator and biologic therapy. A total of 508 patients with Crohn's disease who were naïve to both biologics and immunomodulators (azathioprine, 6-mercaptopurine and methotrexate) were enrolled in the study and were randomized into three groups; azathioprine 2.5 mg/kg/day and placebo infusions, infliximab 5 mg/kg infusions at weeks 0, 2, 6 and every 8 weeks thereafter with placebo capsules and infliximab 5 mg/kg and azathioprine 2.5 mg/kg through 30 weeks. The primary endpoint of SONIC was to assess the induction of steroid-free remission. The safety profiles were similar across all three treatment groups. At week 26, 57 percent of patients receiving infliximab and 44 percent of patients receiving infliximab monotherapy achieved steroid-free remission, the primary endpoint of the study, compared with 31 percent of patients receiving azathioprine alone (P < 0.001 infliximab with azathioprine vs. azathioprine monotherapy; P = 0.009 infliximab monotherapy vs. azathioprine monotherapy; P = 0.022 infliximab with azathioprine vs. infliximab monotherapy). At week 26, 44 percent of patients receiving infliximab combination therapy and 30 percent receiving infliximab monotherapy achieved mucosal healing compared with 17 percent of patients receiving azathioprine alone (P < 0.001 infliximab with azathioprine vs. azathioprine monotherapy; P = 0.023 infliximab monotherapy vs. azathioprine monotherapy; P = 0.055 infliximab with azathioprine vs. infliximab monotherapy).1

About infliximab

Infliximab (Remicade) is a monoclonal antibody that specifically targets TNF. 5 mg/kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Remicade must be given concomitantly with methotrexate. Available data suggest that the clinical response is usually achieved within 6 weeks of treatment. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within this time period.3

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world.

http://www.schering-plough.co.uk

References

1. SONIC abstract

2. National Institute for Health and Clinical Excellence appraisal consultation document - Crohn's disease - infliximab (review) and adalimumab. Issue date: 16 September 2008. http://www.nice.org.uk/guidance/index.jsp?action=article&o=41985

3. Remicade- Summary of Product Characteristics - available at http://emc.medicines.org.uk/. Accessed 21 October 2008.

Schering-Plough