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Immunosuppressants and Antibiotics Bayesian dose adjustment

Pharmacokinetics Newsletter

LIMOGES, Thursday 20th December 2018 

 

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Web Portal  

 

 

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Seasons Greetings

 

 

 

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The TDM team

 

 


¤ In 2019, the ISBA website will be replaced by a new solution called Optim'IS, developed by the Company Optim'Care (an English version will of course be available).

    https://pharmaco.chu-limoges.fr/newsletter/IMG/Interface-Optim-Care.png

*    New characteristics and fonctions:

-          Medical device with the CE marking

-          Certified «healthcare datacentre»

-          Possibility of secured online drug prescription

-          New «draft» request status in order to facilitate data sharing by the health professionals (e.g., transplant physician and local clinical pharmacologist).

-          Simplified request form

-          Possibility of secured online exchanges between requesters and pharmacologists at Limoges to make it possible to share additional information about requests and results.

 

The platform will also provide other solutions (telemonitoring, e-learning for patients …) to help transplant physicians improve patient care

 

 

 

 

 

 

 

 

 

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Monday 17th September 2018

 

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Web Portal

 

 

Hello,

So that more patients can benefit from our teleexpertise for IS dose adjustment and also in order to update ISBA so that it complies with the regulatory requirements, the ISBA web site will be replaced in 2019, first of all in Europe and then in the rest of the world, by a new system, Expert’IS, developed by the company Optim’Care which is a spin- off of our laboratory.

Expert’IS will of course integrate all the models available on the ISBA system and as it is a medical device, will obtain the CE marking (or equivalent outside Europe) before it is put on the market.

Together with Optim’Care, we will contact you individually to prepare the transfer to this new system.

Thank you for your trust,

 

  

 

The TDM team

 

 

 

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Adaptation Bayésienne des ImmunoSuppresseurs, Antibiotiques et Anti-cancéreux

La NEWSLETTER Pharmacocinétique

LIMOGES, le lundi 17 Septembre 2018 

 

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Portail WEB

 

 

Bonjour,

 

Afin de faire bénéficier à un plus grand nombre de patients de notre solution de téléexpertise pour l’adaptation de posologie des IS mais aussi afin de faire évoluer la solution ABIS pour répondre aux exigences réglementaires, le site web ABIS sera remplacé en 2019 dans un premier temps en Europe et d’autres pays par une nouvelle solution, Expert’IS, développée par la société Optim’Care, spin off de notre laboratoire.

 

Expert’IS intégrera bien entendu l’ensemble des modèles disponibles sur ABIS et en tant que dispositif médical devra obtenir le marquage CE (ou équivalent hors Europe) avant sa mise sur le marché.

La société Optim’Care et nous-même vous contacterons individuellement pour préparer le passage à la nouvelle solution.

Merci beaucoup pour votre confiance !

 

 

L’équipe STP

 

 

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Adaptation Bayésienne des ImmunoSuppresseurs, Antibiotiques et Anti-cancéreux

La NEWSLETTER Pharmacocinétique

LIMOGES, le jeudi 5 Octobre 2017 

 

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Portail WEB

 

 

 

Le site ABIS fête sa 100.000ème demande !

 

 

Chers utilisateurs du site ABIS, nous venons de valider la 100.000ème demande d’adaptation d’immunosuppresseurs, depuis avril 2005. Prochain objectif la 200.000ème !

Merci beaucoup pour votre confiance!

  

 

L’équipe STP

 

 

 

Ce mail n'est pas un Spam, vous recevez cette lettre car vous avez demandé à recevoir des informations du laboratoire de Pharmaco-Toxicologie du CHU de Limoges.
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stp@chu-limoges.fr

 

 

 

 

Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Thursday 5th October 2017 

 

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WEB Portal

 

 

 

The ISBA website celebrates its 100,000th request!

 

 

Dear ISBA users, we just validated the 100,000th request for immunosuppressant dose individualization, since April 2005. On the road to the 200,000th!

Thank you so much for your trust!

 

 

The TDM Team

 

 

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Friday 12th May 2017 

 

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WEB Portal

 

 

Hello !

We are pleased to announce the publication of a new article about population pharmacokinetic modeling and Bayesian estimation, which this time is about ENVARSUS®  (Once-daily Tacrolimus) in renal and hepatic transplantation:

Population Pharmacokinetics and Bayesian Estimators for Refined Dose Adjustement of a News Tacrolimus Formulation in Kidney and Liver Transplant Patients

Woillard JB, Debord J, Monchaud C, Saint-Marcoux F, Marquet P.

Clin Pharmacokinet. 2017 Apr 8. Doi : 10.1007/s40262-017-0533-5.

PMID : 28389935

https://www.ncbi.nlm.nih.gov/pubmed/28389935

 

The ISBA platform is thriving and the number of registered transplantation centers is steadily increasing, while the platform’s activity has remained constant during the past year.

We are taking this opportunity to provide you with a quick overview of the website activity:

-       9836 immunosuppressant kinetics have been modeled so far this year, coming from 50 different hospital centers!

-       Among them, the three most active are:

https://pharmaco.chu-limoges.fr/newsletter/news15_ENG_fichiers/image001.jpg

 

Mycophenolic acid remains the most modeled immunosuppressant with about three quarters of the total number of requests:

 

The requests mainly come from metropolitan France and its overseas territories. About 10% of the requests are made by other countries, notably North Africa and the United States of America, or neighbouring countries such as Belgium and Switzerland!

 

The ergonomics of the web portal has been improved, and an ISBA mobile application will be launched in the near future. The interface will also be improved and a question-and-answer forum will be set up.

 

 

Thank you for your trust !

 

 

The TDM Team

 

 

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Immunosuppressants and Antibiotics Bayesian dose adjustment

The Pharmacokinetics Newsletter

LIMOGES, Tuesday 27th December 2016 

 

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WEB Portal

 

 

 

 ¤ The ISBA website has expanded this year :

 

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Envarsus® formulation) in kidney and liver transplantation (optimal sampling times 0, 8 and 12h).

 

-          Population pharmacokinetic models and Bayesian estimators have been developed for tacrolimus (Advagraf® formulation) in liver transplantation (optimal sampling times 0, 2 and 6h).

 

¤ Among our New Year resolutions, we are planning to offer you :

 

-          A new and more ergonomic homepage, adapted for a variety of  screens (tablet, fixed navigator, …)

 

-          A question and answer forum for problems when entering data on ISBA ( coming summer 2017)

 

-          The development of PKJust (dose adjustment of antibiotics), taking into account biological and bacteriological information so as to personalize the therapeutic target.

 

 

Thank you for your trust !

 

 

The TDM Team

 

 

 

 

 Seasons Greetings to you all

 

 

 

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Immunosuppressants Bayesian Dose Adjustment

The I.S.B.A NEWSLETTER

Tuesday 28th June 2016

 

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ISBA

 

 

New Bayesian estimators

 

We are pleased to inform you that new Bayesian estimators dedicated to the tacrolimus formulation Envarsus® in adult kidney and liver transplantation are now available on our ISBA website.

Envarsus® is a once-daily prolonged release formulation of tacrolimus. It is characterized by increased intestinal bioavailability owing to the Meltdose® technology. This leads to the administration of smaller doses (about 30% less) in comparison to other tacrolimus formulations. Since October 2014, Envarsus® has been approved in Europe for the prevention of rejection in kidney or liver transplantation or the treatment of rejection resistant to other immunosuppressants in adult transplant patients.

Veloxis and Chiesi provided us with the pharmacokinetic data of phase 2 clinical trials in renal and hepatic transplantation to allow us to develop population pharmacokinetic models and Bayesian estimators and we express our gratitude to them.

This tacrolimus formulation is characterized by a different pharmacokinetic profile as compared to Advagraf® with, in particular, lower maximal concentration (the figure below gives examples of modeled PK profiles in renal transplantation).

The slow and prolonged release of Envarsus® leads to a different limited sampling strategy for accurate Bayesian estimation of the AUC0-24h: 0, 8, 12h after dose intake for both types of transplantation.

Of note, it is the best limited sampling strategy leading to the lowest bias between predicted and observed AUC0-24h. However, AUC0-24h can be estimated from samples taken at (slightly) different times on condition that the exact times are known.

In conclusion, these new tools are available for adult renal and hepatic transplantation whatever the period post transplantation and the associated immunosupressants.

 

¤ Examples of PK profiles observed and modeled

 

Figure 1-Examples of PK profiles modeled using 3 samples (0, 8, 12h) (in black) and observed (in blue) in adult renal transplant patients in a validation dataset (data splitting).

Zone de Texte: Trapezoidal AUC=149 µg*h/L
3 points AUC=154 µg*h/L
Zone de Texte: Trapezoidal AUC=159 µg*h/L
3 points AUC=178 µg*h/L
Zone de Texte: Trapezoidal AUC=203 µg*h/L
3 points AUC=189 µg*h/L
Zone de Texte: Trapezoidal AUC=190 µg*h/L
3 points AUC=171 µg*h/L
Zone de Texte: Trapezoidal AUC=171 µg*h/L
3 points AUC=169 µg*h/L
Zone de Texte: Trapezoidal AUC=227 µg*h/L
3 points AUC=235 µg*h/L

 

Thank you for your trust!

 

 

The TDM Team

 

 

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Immunosuppressants Bayesian Dose Adjustment

THE I.S.B.A. NEWSLETTER

LIMOGES, Monday May 4, 2015 

 

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ISBA

 

 

The ISBA website is 10 years old!

 

The ISBA website was launched in April 2005 and celebrated its 10th anniversary last month.

This would not have been possible without you, our "customers", who have trusted us since the beginning.

 

¤ 121 transplantation facilities:

No less than 121 different clinical departments, mostly involved in solid organ transplantation, have sent us at least one dose adlustment request. They are located on 6 continents or sub-continents.

 

 

¤ An average of 800 requests per month posted on ISBA:

 

 

¤ 197 different Bayesian estimators...

In line with our understanding of precision medicine, the ISBA website propose dose adjustment tools adapted to your patient profile, based on a panel of 197 different Bayesian estimators, for the different immunosuppressants, transplanted organ or other conditions, drug associations, etc.

 

 

¤ ... for a large panel of organ transplant conditions and auto-immune diseases:

80% of the requests concerned MMF in adult kidney transplant recipients and, at the other end of the spectrum, 5% concerned auto-immune diseases.

 

 

 

 

¤ Finally and most importantly for patient care, results have all been validated by trained pharmacologists and made available after a median time [25-75th percentiles] of 56 minutes!

 

 

 

 

 

Thank you for your trust!

 

 

The TDM Team

 

 

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NEWSLETTER ABIS - DECEMBER 2014
Immunosuppressants Bayesian Dose Adjustment
THE I.S.B.A. NEWSLETTER
Thursday 18th December 2014 
 

ISBA


Seasons Greetings

 


  The TDM Team

¤ In the New Year, the website will be given an overhaul:
  Update of the homepage with new tabs
 
Innovations to discover in the "available tools" tab
 
Launch of the website for the dose adjustment of everolimus and sirolimus on the AUC database
 
¤ Among our New Year resolutions:
  We plan to propose a "frequently asked questions" service to answer your requests
 

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NEWSLETTER ISBA - DECEMBER 2009
Immunosuppressants Bayesian Dose Adjustment
THE I.S.B.A. NEWSLETTER
LIMOGES, Tuesday 15th December 2009 
 

ISBA
 


SEASONS GREETINGS
 


  The TDM Team

¤ Innovations set up on the ISBA website in 2009
  New data sheet for transplantations
  For both MMF and associated CNI
For tacrolimus in the form of Advagraf©
 

This message is not a spam: we are sending it to you because you have asked to receive information on the Pharmacology-Toxicology unit of the Limoges University Hospital.
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ISBA NEWSLETTER - AUGUST 2009
Bayesian adaptation of immunosuppressors
The I.S.B.A NEWSLETTER
LIMOGES, Friday 28th August 2009 
 

ISBA
 
Dear Colleagues,

We are pleased to send you issue n°6 of this newsletter, aimed at keeping you up to date with the latest developments on the ISBA website.

Pierre MARQUET and the Pharmacology-Toxicology team

¤ Innovations to be set up on ISBA website
  New data sheet for the dose adjustment of both MMF and associated CNI:
  Simultaneous capture of the request for MMF and its associated calcineurin inhibitor (cyclosporine or tacrolimus)
  Proposal of a modulated adaptation of both MMF and associated CNI depending on the clinical context
 
New Bayesian estimators:
  For tacrolimus in the form of Advagraf® in adult renal transplants
 
On the ''full kinetic'' page, you can key-in full kinetics and obtain a trapezoidal AUC for all immunosuppressants whatever the situation
 
Cyclosporine concentrations measured with ACMIA® are now accepted
 
¤ Developments underway or planned in the near future
  Dose adjustment of MMF in bone-marrow transplants
 
¤ Waiting period for the validation of the results
  The analysis of the times automatically recorded when keying in and validating the request shows that 63% of the requests are validated within 1 hour, 79% within 24 hours and 97,5% within 72 hours (see table below). Longer waiting periods generally concern requests put on hold while waiting for further information or verification of the concentrations.
 

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NEWSLETTER ABIS - DECEMBRE 2008
Immunosuppressants Bayesian Dose Adjustment
THE I.S.B.A. NEWSLETTER
LIMOGES, Friday 19th December 2008 
 

ISBA
 

SEASONS GREETINGS
 


  The TDM Team

¤ Innovations on the ISBA website
  Integration of VERISIGN©, an SSL security certificate
 
Modification of the results sheet
  Display of the graph on the same page as the dose adjustment proposal
Patient's history : summary of the last 6 adaptations over a period of 2 years
For MMF, graphical visualisation of these last 6 values
 
Opportunity to enter full kinetics in order to obtain an AUC calculation as well as the possibility of dose adjustment, even in the absence of Bayesian estimators. Applies to :
  Kidney, lung, heart and liver transplantations
Auto-immune diseases
 

This message is not a spam but has been sent to you because you have requested information from the Pharmacology and Toxicology Laboratory at the Limoges University Hospital. If you wish to be withdrawn from this mailing list, please send a message to the following email address :stp@chu-limoges.fr
NEWSLETTER ISBA - JANUARY 2008
Immunosuppressants Bayesian Dose Adjustment
The I.S.B.A. NEWSLETTER
LIMOGES, Tuesday 29th January, 2008 
 

ISBA
 
Dear Colleagues,

It is our pleasure to send you the 4th issue of this newsletter, aimed at keeping you up to date with the latest developments on the I.S.B.A. website.

Pierre MARQUET, on behalf of the Pharmacology and Toxicology Team

¤ Statistics on the use of the website up until 31st December 2007
  72 centres registered including 3 from the French overseas departments and territories, 6 from Belgium and 23 from other foreign centres
 
  5232 requests have been made :
  4292 MMF
815 Cyclosporine
125 Tacrolimus
  Context of the requests
  4631 times: kidney transplantation
490 times: hepatic transplantation
87 times: lung transplantation
24 times: Lupus
 
¤ Innovations to be set up as from 1st February, 2008
  Personalized access to the website
  You may have a common login for a department or centre, but passwords should be strictly individual for the traceability of requests, modifications, etc.
Your e-mail address will automatically be inserted
Changes on the request forms:
  You will have the possibility to provide information on the context and reason for the request: checking the previous dose adjustment, systematic follow-up, side effects (digestive problems, neutropenia…), suspicion of rejection.
Condition of the patient with regard to diabetes (the absorption of MMF, cyclosporine and tacrolimus is generally delayed for diabetic patients).

This message is not a spam but has been sent to you because you have requested information from the Pharmacology and Toxicology Laboratory at the Limoges University Hospital. If you wish to be withdrawn from this mailing list, please send a message to the following email address :stp@chu-limoges.fr
ISBA NEWSLETTER - JANUARY 2008
Immunosuppressants Bayesian Dose Adjustment
THE I.S.B.A. NEWSLETTER
Friday 4th January 2008 
 

ISBA
 
GREETINGS FOR 2008


HAPPY NEW YEAR !
 

We wish you good health, happiness and success throughout 2008 !


 
  The TDM team

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NEWSLETTER ISBA - MARCH 2007
Bayesian adaptation of immunosuppressors
The I.S.B.A newsletter
Thursday 22th March 2007, Limoges, France. 
 

ISBA
 
Dear Colleagues,

We are pleased to send you the second issue of this newsletter, aimed at keeping you up to date with the advances made on the ISBA website.

Pierre MARQUET, on behalf of the Pharmacology - Toxicology Team

¤ Statistics regarding the use of the website
  47 registered centers of which two are in French overseas departments and territories, 5 in Belgium and 7 in other foreign countries
Number of requests: 3870 in 23 months
537 CICLO in 10 months
3333 MMF in 23 months
¤ Modifications made on the Internet website
  MPA concentrations measured with the ROCHE® Kit are now accepted.
Possibility to send us requests for MMF dose adjustment for patients suffering from lupus
Possibility to send us requests for Tacrolimus dose adjustment for stable lung transplant patients
On the result sheets, there is a reminder of the previously proposed dosage. The previous request can be redisplayed in one click on the request number
Indication on all the result sheets of the centers who have participated in developing the models
In the window "request listing"
  "Centre n°" taken out
Indicator of the state of advancement of the request: request submitted/ currently being validated/ results (request validated)
 
¤ Developments underway or planned in the near future
  Requests for Sirolimus dose adjustment in renal transplants
Requests for Everolimus dose adjustment in renal transplants
Constitution of Bayesian models in lung and heart transplants for MMF, Ciclosporine, Tacrolimus and Everolimus

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