Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Results from two landmark clinical trials of Centocor and Schering-Plough's Remicade have confirmed the efficacy of the drug in the treatment of ulcerative colitis.
Subscribe to our email newsletter
Ulcerative colitis is one of multiple indications including rheumatoid arthritis, psoriasis, and Crohn’s disease, in which Remicade is either approved or in late stage development.
A pooled analysis from two landmark clinical trials in patients with active ulcerative colitis showed a majority achieved mucosal healing soon after treatment with Remicade, with positive results maintained over time.
More than 60% of patients achieved mucosal healing after eight weeks of treatment, with approximately 50% maintaining results at 30 weeks.
A significantly higher number of patients treated with Remicade also experienced clinical remission after weeks 8 and 30 compared to patients not responding adequately despite treatment with standard therapy (azathioprine and/or steroids).
In addition, two sub-analyses of the trials showed that patients treated with Remicade experienced 50% fewer hospitalizations compared to the control group and reported significant improvements in quality of life.
The findings were presented at the 13th United European Gastroenterology Week (UEGW) meeting.
“These findings should raise our treatment expectations because they show greater success in achieving the long-term goals of healing and remission,” said Dr Paul Rutgeerts, University of Leuven, Belgium and lead investigator of the study.
Currently, there are no biologic therapies approved to treat moderate to severe UC in the EU, a chronic disease with significant impact on quality of life which affects over 700,000 people in Europe. Alternative treatments are limited and, if conventional treatments do not control the symptoms of the disease, many patients may have to face surgical removal of the colon.
Schering-Plough markets Remicade in all countries outside of the US, except in Japan and parts of the Far East where Tanabe Seiyaku Ltd markets the product and in China where Xian-Janssen markets Remicade. Centocor, a wholly owned subsidiary of Johnson & Johnson, has exclusive marketing rights to the product in the US.