First-ever study in transplant patients utilized patient-reported measurement tools to differentiate between quality of life of existing therapies
Geneva, October 19, 2005 - Results of the PROGIS study released at the European Society for Organ Transplant (ESOT) meeting showed that 66% of patients who suffered gastrointestinal (GI) complaints while on mycophenolate mofetil (MMF) following kidney transplantation surgery reported an overall improvement in GI symptoms when converted to Myfortic® (enteric coated mycophenolate sodium).
Data from PROGIS (Patient Reported Outcomes in renal transplant patients with or without Gastro-Intestinal Symptoms) also showed that converting MMF patients who experienced GI problems to Myfortic significantly reduced their symptom burden while significantly improving their gastrointestinal and general well-being (p < 0.001).
These findings provide for the first time in transplantation insight into the value of patient-reported measurement tools as a way of differentiating the impact of adverse events with immunosuppressive therapies. This study also confirmed that MMF-associated gastro-intestinal effects had a significant impact on the health-related quality of life and psychological well-being of the study patients.
"Patient Reported Quality of Life measurements have been used successfully in other treatment areas such as oncology," said Professor Paul Keown, MD, Director of Immunology and Head of Nephrology at the University of British Columbia. "This is the right time to apply these assessment tools to transplant patients to further our understanding of how to improve care in patients who have gone through very intensive medical management."
Dr Shamkant Mulgoankar, Chief of the Division of Transplantation for the St Barnabas Health Care System and one of the leading investigators in the study, said: "These first data are very encouraging results for the transplant community as this is the first study to evaluate patient functioning and well-being among patients converted from MMF to Myfortic because of GI complaints. Clinicians can now use these results to guide their considerations of treatment options for patients with GI complaints."
PROGIS is an open-label, multicenter, longitudinal study that utilised four different patient-reported Quality of Life questionnaires to identify the burden of gastrointestinal symptoms related to the two mycophenolic acid formulations (Myfortic and MMF) in kidney transplanted patients. Changes in GI-specific symptoms burden from baseline were reported by patients using the Gastrointestinal Symptoms Rating Scale (GSRS) as well as the Overall Treatment Effect (OTE) scale after four to six weeks of treatment. Other scales used were GIQLI (GI Quality of Life Index) and PGWBI (Psychological Well-Being Index).
Myfortic is an enteric-coated formulation of mycophenolic acid and is approved in over 50 countries, including the US and major European countries. Myfortic is indicated for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal transplants in combination with ciclosporin for microemulsion and corticosteroids.
This release contains certain forward-looking statements that can be identified by the use of forward-looking terminology, such as "are very encouraging", or similar expressions, or by express or implied discussions regarding the potential benefits and the potential future sales of Myfortic. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause the actual results with Myfortic to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Myfortic will reach any particular sales levels. Any such results can be affected by, among other things, uncertainties relating to clinical trials, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, government, industry, and general public pricing pressures, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
About Novartis
The Novartis Transplantation and Immunology Business Unit is committed to developing an innovative range of therapeutic products for the prevention of organ rejection, in order to provide an extensive choice of drugs to the transplant community and to maintain the role of Novartis as a global market leader in this field of medicine.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.1 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 91,700 people and operate in over 140 countries around the world.
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References
Kleinman L. GI-specific patient-reported outcome instruments differentiate between renal transplant patients with or without GI complications. Transplnt. Proc. 2005; 37:846-849
Mulgaonkar S. Positive impact on health related QoL in patients converted from MMF to enteric-coated MPS due to GI complaints. Presented at ESOT, Geneva, October 2005
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