Possibility of standardized treatment options for natural transplant patients
• TransFORM clinical analysis, a large scale interval research on patients with renal transplantation, gave high immunosuppression, retinal renal function and viral infection in Asian patients compared to all transplant patients1, 2
• The results of the 24-month analysis of the TRANSFORM Asia region, the most common among Koreans, indicated that the tertiary treatment group was a superior effect to the mycophenolate treatment group1, 3
• Cytotan, TRANSFORM Asia Data contains standardized potential renal transplant patients. The need to improve the availability of treatment for patients with renal transplantation in Korea
Novartis has announced that his transplant immunosuppressant,®(Evelorimus) gave better therapeutic effect to patients with asylum transplantation in comparison to patients with complete renal transplantation. 1 The results were presented at the Asian Transplantation Week 2018 in BeXCO, Busan, from 8 November to 10 November.
The study of TRANSFORM was the largest intervention survey of 2,037 renal transplant recipients of 186 institutions in 42 countries. The study contains a combination of controlled corticosterone and a low-density metabolism inhibitor (CNI). It is a comparative study of CNI-combination therapy with phenolic acid and exposure standard. 2 The subanalysis of the Asian region consisted of 262 patients in 8 countries such as Korea, Japan and India, with 53 patients in Korea. 1, 3
TRANSFORM Study A 24-month analysis of Asian data was the specific biopsy-proven acute screening (MDBD) or MDRD4 formulated for glomerular filtration rate (eGFR) * in the tertiary group 50 ml / min / 1, 73 m2 (Primitive Effective Pointpoint) was 26.7%, lower than or of control group, mycophenolic sack treatment, by 38.0%. (95% CI: -22.3, 0.5; P = 0.061) 1, * The combined risk of transcatheter, recorded acupuncture, increase in loss, and death in the treated group was significantly lowered in 8.4%, compared with 21.4% in & # 39; the control group. (95% CI: -21.5, -4.6; P = 0.002) 1 These results include the superior immunosuppressive effect in Thotianum group compared to the control group.
* Estimated glomerular filtration (eGFR): an indicator that evaluates renal function. Spreaker how many milliliters of glomeruli can filter for 1 minute based on body surface. 4
This study also ordered the important conservative effect of cortics. 1 CNI is a standard immunosuppressant that is used in renal transplant patients, but it can cause nausea and lead to cardiovascular cessation or malignant tumors in the long run. 5, 6, 7 In this study, the tested glomerular filtration quality was treated at all points, when Canticans and CNI were used in combination with mycophenolic acid and CNI. 1
Virus infections were also lower in the corticans treated group. 1 Transplantical patients can easily be infected with the virus, to reduce their immune system to transplantation. 8 Viral infection is an important source of post-transplant evaluation due to the increased risk of fungi and death at the time of infection. As a result of study, the total virus infection in each treatment group was 15.0% and 35.9%, respectively (P = 0.000) 1 The infection of BK virus (3.3% to 9.2%, P = 0.057) was about 3 times lower than that of the control group and the infection of cytotoxic virus (4.2% to 16.2%, P = 0.002) Compared with the control group. 1
Professor Myung Soo Kim, a transplant surgeon in Shinchon Severance Hospital, participated in this study. "Through the result of TRANSFORM Research Asia, we can confirm the strong immunosuppressive effect, preserve new function, and reduce viral infection." We have confirmed the potential of TICAN as standard treatment for renal transplant patients by seeing great results in patients with asthetic transplantation. "Renal transplantation is direct connection to the life of a patient, including complications such as transplantation," It is necessary to improve access to treatments such as salary application, so patients with renal transplantation Spreading organs can be prevented by the use of cortisans, "he said.
On the other hand, cortisans mTOR inhibitors of pro-symbol inhibitors prevent the occurrence that can be carried out as organ transplantation. They are used for treating natural and heart transplantation with a measurable immunological risk, It is approved if a treatment is prevented from occurring, and is the only medicines with index for both heart and kidneys and liver transplantation under mTOR inhibitors. 9, 10
* About TRANSFORM2
TRANSFORM is a 24-month open labels, two-arm, randomized, controlled problem for the largest neointimal interdisciplinary study in 2,037 renal transplant patches in 186 institutions in 42 countries. In TRANSFORM study, combined therapy with control dose cortisans and a lower dose calcium inhibitor (CNI) is compared to a combination of mycophenolic acid and an exposure standard of calcineurine inhibitor.
Patients participating in the study were randomly extracted at a 1: 1 ratio within 24 hours after transplantation, which was stratified based on donor type, type of calcineurin inhibitor, and so on. The results of the first analysis were made after 12 months. The primary efficacy-point of TRANSFORM study was the route of transplantation deviations and certain glomerular filtration gases (eGFR), which was less than 50 ml / min. The secondary efficacy parameters were transplanted acute absorption,.
* About Certican
It is a mTOR inhibitor of a pro-symbol inhibitor family that eliminates the deviation response that occurs when transmission of organs occurs. It is used for the treatment of natural and hormonal transplantation with a moderate immunological risk and organ transplantation and was approved as a treatment to prevent the reaction. 9
Thoracic (efficacy) Kidney and transplantation: Prevention of transplant rejection for transplantation in adult patients with allergic or kidney transplantation with moderate, moderate immunological risk. For use in nature and heart transplantation, Drug is combined with cysticporine and cortisol in the form of microemulsions.
Liver Planning: Prevention of organs transplantation to transplantation in adult patients with liver transplantation. When used in transplantation, medication is administered in combination with tacrolimus and corticosteroids. 9
* About Novartis Korea
Novartis Korea (www.novartis.co.kr), a subsidiary of Novartis, has a global pharmaceutical and biofarmaceutical company, has approximately 740 employees, including SanDos Korea, a general division, and Korea Alcon, an eye-catcher. Novartis Korea has found approximately 200 clinical problems in Korea for the last 10 years and has been working actively with domestic researchers. It is actively participating in various programs such as CHEER YOU & # 39; We will do our best to make a business that contributes to local community in various social activities such as # 39; Ji-eun,, & # 39; Gahwa Mam Sung Sung, a support for cancerous diseases and deaths. Community Service Day & # 39; Is there.
1. Myoung Soo Kim, Yoshihiko Watarai et al. Effect of Everolimus with Reduced Exposure Calcineurin Inhibitor Versus Mycophenolate with Standard Exposure Calcineurin Inhibitor in Kidney Transplants Receiver of the Asian Region: Subpopulation Analysis of TRANSFORM Studies. Data printed by: Asian Transplantation Week 2018, Nov 8-10; Busan, Korea.
2. Julio Pascual, Stefan Berger et al. Everolimus with Reduced Calcinuerin Inhibitor Exposure in Renal Transplantation. J Am Soc Nefrol 29: 1979-1999, 2018.
3. Julio Pascual, Stefan Chadban et al. Effectiveness and safety of Everolimus with Reduced Dose Calcineurin Inhibitor in Novo-Nier Transplant Receiver: Results from TRANSFORM Studies. Data presented at: 27th International Conference of the Transplantation Association, June 30 – July 5; Madrid, Spain.
4. Inmi, Im In Seok. Examples of different methods of measuring glomerular filtration phases in pediatric patients. Korean periodic kindergarten system. 2009, Vol. 52 no. 9.
5. J. R. Chapman. Chronic Calcineurin Inhibitor Nephrotoxicity Lest We Fergye. American Journal of Transplantation 2011; 11: 693-697.
6. Allison Webber et al. Spatial strategies in immune suppression: problems in perspective. Transplantation. 2011, fol 91. No 10.
7. Shelly Lichtenberg et al. The incidence of post-transplant cancer in kidney transplants is linked to the level of tacrolimus exposure in the first year after transplantation. Eur J Clin Pharmacol (2017) 73: 819-826.
9. Certican Product Manual
10. Sylolimus effectiveness