Thursday, October 29, 2009

New data confirm the remission of Crohn's disease

New data confirm the remission of Crohn's disease with the combined use of Remicade ® (infliximab) and azathioprine.

The results were made public during the Fourth Congress of the European Crohn's and Colitis Organization recently held in Hamburg Colitis

Around 69% of patients with Crohn's disease of moderate to severe and high levels of C reactive protein (CRP) and mucosal lesions go into remission with combination therapy of infliximab and azathioprine according to a subanalysis of the study SONIC

In Spain there are about 40,000 affected by Crohn's disease that first manifests itself in people between 15 and 30 years and are suffering from reduced quality of life


Results from a subanalysis of SONIC Phase III Study of Patients with Crohn's Disease, Naïve to Immunomodulators and Biologic Therapy among Patients suffering from these moderate to severe disease with high levels of C-reactive protein (CRP) have shown high rates of remission when treated with Remicade ® (infliximab), either alone or in combination with azathioprine. Specifically, 69% have achieved the goals of clinical disease remission and mucosal healing at week 26.

These figures confirm the main objectives set by the SONIC study that show how biological therapies that are based Remicade ® (infliximab) in combination therapy or monotherapy increased clinical remission of Crohn's disease and scarring of the mucosa after 26 weeks of treatment. 57% of all patients seen in the SONIC study who were treated with Remicade ® (infliximab) and azathioprine in combination achieved remission. This finding highlights on the 44% of patients reported treatment benefits only infliximab monotherapy and 31% of those who received only azathioprine.


Main results of the subgroup of patients analyzed
The results arising from this sub-analysis at 26 weeks of treatment SONIC study fall into three study groups:

 Patients with elevated CRP levels and mucosal lesions (40% of patients observed):
or treatment with Remicade ® (infliximab) and azathioprine (69% remission), monotherapy with Remicade ® (infliximab) (57%), treatment with azathioprine (28%)

 Patients who reported high levels of C-reactive protein (≥ 0.8 mg / dL), which account for 58%. In this case, the results recorded are:
or treatment with Remicade ® (infliximab) and azathioprine (64% remission), monotherapy with Remicade ® (infliximab) (48%), treatment with azathioprine (28%)

 Patients with mucosal lesions (64% of patients observed in the study):
or treatment with Remicade ® (infliximab) and azathioprine (61% remission), monotherapy with Remicade ® (infliximab) (51%), treatment with azathioprine (30%)


According to Dr. Jean Frederic Colombel, Professor of Hepatogastroenterology Hospital Center of Lille, the results of the SONIC study have been very well received by gastroenterologists met in Hamburg, as they show some great benefits for patients and efficacy data and safety Remicade ® in the treatment of chronic inflammatory bowel disease remission by recording the inflammation and healing of mucosal lesions.

About SONIC
SONIC is a randomized clinical trial phase III, double-blind, designed to compare the efficacy and safety of Remicade ®, azathioprine monotherapy and combination therapy of both drugs in patients with Crohn's disease of moderate to severe and had not received treatments previously immunomodulators and biologic therapies. Of the total 508 patients who participated in the study, 170 were treated with azathioprine 2-2.5 mg / kg / day and placebo, 169 patients received REMICADE ® 5 mg / kg at weeks 0, 2, 6 and every 8 weeks then with placebo capsules and 169 patients received REMICADE ® 5 mg / kg and azathioprine 2 to 2.5 mg / kg for 30 weeks. 52% of patients were men with a mean age of 34 years with a mean disease duration of 2.3 years.

Crohn's Disease
Crohn's disease is a chronic inflammatory bowel disease that affects more than 400,000 people in Europe, over 40,000 of them registered in Spain. This disease is characterized by having a direct impact on quality of life for those affected because, besides suffering from hospitalization, surgery and loss of productivity, have episodes where they can get to having to urinate up to 25 times a day. It also gave the patient a disease that costs about as it is a chronic disease that, while not fatal, unpleasant symptoms that are a taboo subject among the general population.


Schering-Plow
Schering-Plow is a global pharmaceutical company dedicated to health care through scientific innovation. Through internal research and collaborations with partners, Schering-Plow researches, develops, manufactures and markets advanced drug therapies to help save lives and improve quality of life for many people around the world. For that the company applies its research and development of prescription and consumer products and animal health.

The mission of Schering-Plow and professional account with which everyone is "Winning the trust, day by day" of doctors, patients and customers. The Company is based in Kenilworth (New Jersey, USA). His website is http://www.schering-plough.com plough.es Spain.

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