Most recent edit on 2007-11-17 08:53:36 by JasonD [Restored to Original Version by Kathy]
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~*New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA? (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
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olodomtrnor
*New Analysis Of Data Shows Treatment With Abbott's HUMIRA® Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
New Analysis Of Data Shows Treatment With Abbott's HUMIRA® Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA® (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
Edited on 2007-11-16 13:10:12 by ElalvArdel
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olodomtrnor
*New Analysis Of Data Shows Treatment With Abbott's HUMIRA® Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
New Analysis Of Data Shows Treatment With Abbott's HUMIRA® Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA® (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
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~*New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA? (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
Edited on 2007-06-17 08:34:15 by KathyFromEngland
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~*UCB Presents Long-Term CIMZIA(TM) Data In Crohn's Disease
UCB Presents Long-Term CIMZIA(TM) Data In Crohn's Disease
23 May 2007
UCB announced today that new data presented at Digestive Disease Week 2007 (DDW) demonstrated long-term response and remission in Crohn's disease patients treated with CIMZIA(TM) (certolizumab pegol), the only Fc-free PEGylated, Fab' fragment anti-TNF.
The study, called
PRECiSE 3 (P3), is a long-term open label continuation of the Phase III
PRECiSE Program for CIMZIA(TM). Some of the study results presented at DDW are an interim analysis of a patient subgroup that responded continuously to CIMZIA(TM) during an 18-month period. These patients completed the
PRECiSE 1 (P1) or
PRECiSE 2 (P2) trials, enrolling in P3 at week 26. At week 80, the study showed that more than 85 percent of the patient subgroup who continuously received CIMZIA(TM) 400 mg subcutaneously every four weeks maintained clinical response, with nearly 74 percent of these patients achieving remission. (1) The extension study used the Harvey-Bradshaw Index (HBI)(a) to assess clinical response (defined as a reduction in HBI score of at least three points) and remission (HBI score less than or equal to four points).
Importantly, results reported from P3 indicated that CIMZIA(TM) was well- tolerated throughout the study. The percentage of patients experiencing injection-site reactions and injection-site pain was low (<2%, <1% respectively). (3)
"These study results show robust rates of clinical response and remission during an 18-month period in patients with Crohn's disease," said Stephen Hanauer, M.D., Professor of Medicine and Clinical Pharmacology Chief, Section of Gastroenterology and Nutrition, University of Chicago, and study co-author. "Also, CIMZIA(TM) dosing did not need to be increased over the course of the study."
"These results fortify UCB's commitment to obtain regulatory approval for CIMZIA(TM) in the treatment of Crohn's disease. They help demonstrate the benefits CIMZIA(TM), administered subcutaneously every four weeks, can offer to those suffering from this debilitating condition," commented Olav Hellebo, Senior Vice President and President of Inflammation Operations, UCB.
PRECiSE 3 Study Design
CIMZIA(TM) was administered subcutaneously every four weeks at stable doses of 400 mg, with an induction dose at weeks 0, 2 and 4. The patients represented a broad population living with moderate to severe Crohn's disease, including patients who had previously received infliximab, another biologic for the treatment of Crohn's, those treated with monotherapy, or those treated with immunosuppressants.
P3 is an open-label extension study that recruited a total of 595 patients from the placebo-controlled studies P1 and P2. Group A (329 patients) responded to treatment and completed the P1 and P2 clinical trials. Upon completion, the patients enrolled in P3. Group B (99 patients) responded to induction therapy with CIMZIA(TM) in P2 at Weeks 0, 2 and 4, and were randomized to placebo in P2 and then enrolled in P3. Groups A and B received CIMZIA(TM) in the P3 study.
The primary endpoint of P3 was to assess the safety of chronic therapy with CIMZIA(TM). The secondary endpoints were to obtain data on plasma concentrations and antibodies to CIMZIA(TM) and to obtain additional efficacy data with up to 18 months continuous exposure to CIMZIA(TM).
For patients with continuous exposure to CIMZIA(TM) during P1 and P2 (Group A), at week 52, 78.8 percent (204/259 patients) maintained clinical response and 65.6 percent (170/259 patients) maintained remission as measured by a reduction in HBI score of at least three points and a remission HBI score of less than or equal to four. At week 80, response and remission was maintained by 85.8 percent (182/212 patients) and 73.6 percent (156/212 patients), respectively. Patients who were randomized to placebo in P1 or P2 (Group B) and who began treatment again in P3, maintained response and remission by 86.8 percent (59/68 patients) and 75 percent (51/68 patients), respectively, at week 80. Patients who did not complete or withdrew from P3 were counted as non-responders and were not included in this analysis.
http://www.medilexicon.com/medicalnews.php?newsid=71790∞
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Edited on 2007-06-17 08:29:39 by KathyFromEngland
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~*PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week
PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week
23 May 2007
Data presented at the Digestive Disease Week (DDW) meeting this week in Washington D.C. by Dr. William Sandborn from the Mayo Clinic suggest that Nuvion (visilizumab), an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis (IVSR-UC), administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated. The results presented were from long-term follow up of 138 patients who had received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy procedures performed in the U.S. each year. In addition, early data also will be presented at the meeting regarding the Nuvion antibody's potential as a treatment for Crohn's disease.
http://www.medilexicon.com/medicalnews.php?newsid=71791∞
Edited on 2007-06-17 08:27:44 by KathyFromEngland
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~*PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week
PDL BioPharma Announces Long-Term Nuvion(R) Data Presented At 2007 Digestive Disease Week
23 May 2007
Data presented at the Digestive Disease Week (DDW) meeting this week in Washington D.C. by Dr. William Sandborn from the Mayo Clinic suggest that Nuvion (visilizumab), an antibody in development as a treatment for intravenous steroid-refractory ulcerative colitis (IVSR-UC), administered on day 1 and day 2, produced a sustained clinical response up to 310 days and was adequately tolerated. The results presented were from long-term follow up of 138 patients who had received Nuvion in a Phase 1 and Phase 1/2 study as a treatment for IVSR-UC, which contributes to the majority of an estimated 30,000 colectomy procedures performed in the U.S. each year. In addition, early data also will be presented at the meeting regarding the Nuvion antibody's potential as a treatment for Crohn's disease.
http://www.medilexicon.com/medicalnews.php?newsid=71791∞
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Edited on 2007-06-16 11:42:16 by KathyFromEngland
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~*New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
New Analysis Of Data Shows Treatment With Abbott's HUMIRA? Significantly Reduced Disease-Related Hospitalization For Patients With Crohn's
24 May 2007
Abbott today announced results from a post-hoc analysis of a pivotal study presented at the Digestive Disease Week annual meeting in Washington, D.C. showing patients with moderate to severely active Crohn's disease treated with HUMIRA? (adalimumab) maintenance therapy were almost 60 percent less likely than patients on placebo to be hospitalised due to their disease at one year (5.9 percent versus 13.9 percent; p<0.01).
Crohn's disease is a serious, chronic, inflammatory disease of the gastrointestinal (GI) tract that affects more than one million people in North America and Europe. It affects people of all ages but it is primarily a disease of young adults, with onset typically before age 40. There is no medical or surgical cure for Crohn's disease, so maintenance of remission from disease flares is one of the primary goals of treatment.
People with Crohn's disease may be hospitalised for a variety of reasons, from fever and vomiting to intestinal obstruction and infections, sometimes leading to surgery. Previous studies have shown that hospitalisation is responsible for approximately 60 percent of the direct cost of Crohn's disease and that the average cost per hospital stay is estimated (based on published cost data from 1997) to be about $37,000 per patient in 2006 dollars. Hospitalisation is also associated with a negative impact on health-related quality of life in patients with Crohn's disease.
Data from the Phase III, pivotal study, called CHARM, were evaluated to assess the effect of ongoing treatment with HUMIRA on the risk of hospitalisation. At one year, this analysis showed that patients taking placebo (13.9 percent) were more than twice as likely as patients on HUMIRA (5.9 percent; p<0.01) to be hospitalised from Crohn's disease.
"Patients on HUMIRA throughout the one-year analysis were significantly less likely to be hospitalised because of their Crohn's disease. Maintaining treatment with HUMIRA was the only independent factor in this analysis that helped patients reduce the risk of Crohn's related hospitalisation," said Brian G. Feagan, M.D., lead investigator of the analysis, Department of Medicine, Epidemiology and Biostatistics, University of Western Ontario, London Health Sciences Centre, London, ON, Canada.
http://www.medilexicon.com/medicalnews.php?newsid=71875∞
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Edited on 2006-07-27 02:55:58 by KathyFromEngland
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Categories
CategoryBowelDisease
Edited on 2006-07-25 15:37:46 by KathyFromEngland
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Dr. Borody MD PhD FRACP, a graduate of the University of New South Wales, from which he holds a doctorate in medicine, will be presenting his findings in an open forum at:
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Dr. Borody MD PhD FRACP, a graduate of the University of New South Wales, from which he holds a doctorate in medicine, will be presenting his findings in an open forum at:
Edited on 2006-07-23 07:14:36 by KathyFromEngland
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About Crohn's Disease Treatment Methods
Articles about which Crohn's Disease Treatment Methods are working well etc.
*Crohn's Disease - Professor Thomas Borody Of Australia Comes To New York To Discuss Significant New Findings
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Title 1
Oldest known version of this page was edited on 2006-07-21 23:31:49 by KathyFromEngland []
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Articles about which methods are working well etc.
Contents
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Crohn's Disease - Professor Thomas Borody Of Australia Comes To New York To Discuss Significant New Findings
02 Mar 2006
Professor Tom Borody of Sydney, Australia will present the results of over 20 years of research into an effective treatment for
Crohn's Disease. He will deliver data from a clinical study of 213 patients in Australia along with the responses to treatment of over 50 of Prof. Borody's own patients, to his anti-mycobacteria therapy research.
According to Prof. Borody's report, as many as 95% of his patients have responded to treatment with full remission achieved by 65% of these patients. Dr. Borody says, "These results exceed all documented evidence of response to Crohn's Disease therapies and promise significant relief for a large number of the estimated one million Crohn's patients around the world."
Dr. Borody MD
PhD FRACP, a graduate of the University of New South Wales, from which he holds a doctorate in medicine, will be presenting his findings in an open forum at:
The Suffolk Y Jewish Community Center
74 Hauppauge Road in Commack, Long Island
March 20, 2006 from 7-9 PM.
Suggested donation $3
As the founder and current Medical Director of the Centre for Digestive Diseases (CDD), Dr. Borody has created a unique medical institution, internationally regarded for its novel approaches in research, diagnosis and the treatment of gastrointestinal conditions. He has been a recipient of the Winthrop Traveling Fellowship, the Neil Hamilton Fairly Fellowship and the Marshall & Warren Prize, and was a Clinical Fellow in Gastroenterology at the Mayo Clinic in Rochester in 1983. He is a member of the Australian Medical Association, the Gastroenterological Society of Australia, the European Gastroenterology Society, the Functional Brain-Gut Research Group and Fellow of the American College of Gastroenterology and the American College of Physicians.
Prof. Borody supervises a number of major research programs as well as being involved as a reviewer for the American Journal of Gastroenterology, Digestive Diseases and Sciences, Endoscopy, Journal of Gastroenterology and Hepatology, Medical Journal of Australia and Digestive and Liver Diseases. He has published in excess of 120 scientific papers. In 2004 he was appointed an Adjunct Professor of the Faculty of Science at the University of Technology, Sydney.
The Suffolk Y JCC is an agency of UJA Federation and affiliated with JCC Association. Additional funding is provided by the United Way of Long Island and the Townwide Fund of Huntington. The Suffolk Y JCC takes no position on the efficacy of Dr. Borody's treatment.
http://www.syjcc.org∞
http://www.medilexicon.com/medicalnews.php?newsid=38664∞