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Practical Recommendations for Long-term Management of Modifiable Risks in Kidney and Liver Transplant Recipients: A Guidance Report and Clinical Checklist by the Consensus on Managing Modifiable Risk in Transplantation (COMMIT) Group

Neuberger, James M. MD, FRCP; Bechstein, Wolf O. MD, PhD; Kuypers, Dirk R.J. MD, PhD; Burra, Patrizia MD, PhD; Citterio, Franco MD, FEBS; De Geest, Sabina PhD, RN; Duvoux, Christophe MD, PhD; Jardine, Alan G. MD, FRCP; Kamar, Nassim MD, PhD; Krämer, Bernhard K. MD; Metselaar, Herold J. MD, PhD; Nevens, Frederik MD, PhD; Pirenne, Jacques MD, MSc, PhD; Rodríguez-Perálvarez, Manuel L. MD, PhD; Samuel, Didier MD, PhD; Schneeberger, Stefan MD; Serón, Daniel MD, PhD; Trunečka, Pavel MD, PhD; Tisone, Giuseppe MD; van Gelder, Teun MD, PhD

doi: 10.1097/TP.0000000000001651
Supplement

Short-term patient and graft outcomes continue to improve after kidney and liver transplantation, with 1-year survival rates over 80%; however, improving longer-term outcomes remains a challenge. Improving the function of grafts and health of recipients would not only enhance quality and length of life, but would also reduce the need for retransplantation, and thus increase the number of organs available for transplant. The clinical transplant community needs to identify and manage those patient modifiable factors, to decrease the risk of graft failure, and improve longer-term outcomes.

COMMIT was formed in 2015 and is composed of 20 leading kidney and liver transplant specialists from 9 countries across Europe. The group’s remit is to provide expert guidance for the long-term management of kidney and liver transplant patients, with the aim of improving outcomes by minimizing modifiable risks associated with poor graft and patient survival posttransplant.

The objective of this supplement is to provide specific, practical recommendations, through the discussion of current evidence and best practice, for the management of modifiable risks in those kidney and liver transplant patients who have survived the first postoperative year. In addition, the provision of a checklist increases the clinical utility and accessibility of these recommendations, by offering a systematic and efficient way to implement screening and monitoring of modifiable risks in the clinical setting.

1 Liver Unit, Queen Elizabeth Hospital Birmingham, United Kingdom.

2 Department of General and Visceral Surgery, Frankfurt University Hospital and Clinics, Germany.

3 Department of Nephrology and Renal Transplantation, University Hospitals Leuven, Campus Gasthuisberg, Belgium.

4 Department of Surgery, Oncology, and Gastroenterology, Padova University Hospital, Padova, Italy.

5 Renal Transplantation Unit, Department of Surgical Science, Università Cattolica Sacro Cuore, Rome, Italy.

6 Department of Public Health, Faculty of Medicine, Institute of Nursing Science, University of Basel, Switzerland.

7 Department of Public Health, Faculty of Medicine, Centre for Health Services and Nursing Research, KU Leuven, Belgium.

8 Department of Hepatology and Liver Transplant Unit, Henri Mondor Hospital (AP-HP), Paris-Est University (UPEC), France.

9 Department of Nephrology, University of Glasgow, United Kingdom.

10 Department of Nephrology and Organ Transplantation, CHU Rangueil, Université Paul Sabatier, Toulouse, France.

11 Vth Department of Medicine & Renal Transplant Program, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany.

12 Department of Gastroenterology and Hepatology, Erasmus MC, University Hospital Rotterdam, the Netherlands.

13 Department of Gastroenterology and Hepatology, University Hospitals KU Leuven, Belgium.

14 Abdominal Transplant Surgery, Microbiology and Immunology Department, University Hospitals KU Leuven, Belgium.

15 Department of Hepatology and Liver Transplantation, Reina Sofía University Hospital, IMIBIC, CIBERehd, Spain.

16 Hepatobiliary Centre, Hospital Paul-Brousse (AP-HP), Paris-Sud University, Université Paris-Saclay, Villejuif, France.

17 Department of Visceral, Transplant and Thoracic Surgery, Innsbruck Medical University, Austria.

18 Nephrology Department, Hospital Vall d’Hebrón, Autonomous University of Barcelona, Spain.

19 Transplant Center, Institute for Clinical and Experimental Medicine (IKEM), Prague, Czech Republic.

20 Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Italy.

21 Department of Hospital Pharmacy and Internal Medicine, Erasmus MC, the Netherlands.

Received 14 October 2016. Revision received 21 December 2016.

Accepted 6 January 2017.

Disclosure and contributions: The concept of the Consensus On Managing Modifiable risk In Transplantation (COMMIT) program arose from feedback following the Astellas Pharmaceutical Europe Ltd-sponsored meeting ‘Advancing Transplantation: New questions, New possibilities’ held at the Karolinska Institute in Sweden in January 2015 (Transplantation. 2017;101:S1–S41). The authors were approached by Astellas to discuss the practical implementation of evidence and discussion from the meeting related to managing modifiable risk factors in posttransplantation care.

COMMIT is an expert-led program. The authors formed a “consensus group” which met at various times over a period of approximately 1 year to discuss the development of a practical guidance document. Led by chairs, James Neuberger, Wolf Bechstein and Dirk Kuypers, the group developed their own content for their meetings, with editorial support from iS Health. Astellas had input into the selection of the program members and the appointment of iS Health to support the program. Astellas Pharma Europe Ltd has provided support in the form of funding for the meeting expenses, secretariat services by iS Health, and placement of the supplement (guidance report and checklist) in the journal selected by the authors.

Expert comments and guidance provided in this supplement are based on the clinical experience and independent opinion of the authors, and reference published clinical trial data. Previously unpublished data that could not be included, due to existing embargo policies or to protect intellectual property, have been excluded from this guidance document. The unpublished data in this document were included at the discretion of the authors as personal communications. All authors had final editorial authority over the content and approved the final version of this supplement before submission. Astellas has had no influence or input into the content development of the document.

Astellas Pharma and associated companies developed, manufacture and supply tacrolimus (tacrolimus hard capsules (Prograf™), tacrolimus prolonged-release hard capsules (Advagraf™)). Prescribing information can be found on page S54.

Advagraf is not licenced for patients receiving allogeneic liver transplants in the United States. Discussions of tacrolimus dosing protocols unsupported by the Advagraf license recommendations are included based on the clinical opinion of the authors and referenced to published data.

J.M.N. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Intercept, Roche, outside of the submitted work. D.R.J.K. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Roche, Pfizer, BMS, Chiesi, Polyphor, Alexion, Opsona Therapeutics; grants from Astellas, Novartis and Roche, outside of the submitted work. W.O.B. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Amgen, Astellas, Celgene, Dansac, Integra, Johnson and Johnson, LifeCell, Medupdate GmbH, Merck Serono, Novartis, Pharmacept, Roche; grants from Astellas, Baxter, Novartis, Pfizer, outside of the submitted work. P.B. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Kedrion, Grifols, Biotest, Gilead, Alfa Wassermann, outside of the submitted work. F.C. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, BMS, outside of the submitted work. S.D.G. reports nonfinancial support from Astellas during the development of this supplement; grant support from Astellas, Novartis, Roche and Sanofi, outside of the submitted work. C.D. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Chiesi; grants from Astellas, Novartis and Roche, outside of the submitted work. A.G.J. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Amgen, Novartis, Genzyme, Relypsa, AstraZeneca, Boehringer Ingelheim, Bayer, Opsona Therapeutics; grants from Novartis, outside of the submitted work. N.K. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Amgen, Novartis, Roche, Neovii, Sanofi; grants from Astellas, Novartis, outside of the submitted work. B.K.K. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Amgen, Astellas, Bayer, BMS, Chiesi, Hexal, Opsona Therapeutics, Pfizer, outside of the submitted work. H.J.M. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Intercept, Biotest; grants from Astellas, Biotest, Gilead, outside of the submitted work. F.N. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Centrale Afdeling Fractionering (CAF), Intercept, Gore, BMS, Abbvie, Novartis, MSD, Janssen-Cilag, Promethera Biosciences, Ono Pharma, Durect, Gilead; grants from Roche, Astellas, Ferring, Novartis, Janssen-Cilag, Abbvie, outside of the submitted work. J.P. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas; grants from Astellas, Roche, Centrale Afdeling Fractionering (CAF), Institut Georges Lopez (IGL), outside of the submitted work. M.L.R.-P. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis; grants from Astellas, outside of the submitted work. D.S. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Biotest, Abbvie, Gilead, Intercept, MSD, LFB; grants from Astellas, Novartis, Gilead, outside of the submitted work. S.S. reports nonfinancial support from Astellas during the development of this supplement; outside of the submitted work: fees for Expert Groups/Advisory Boards from Astellas, Novartis, Teva, Sandoz; fees for Steering Committees: Astellas; unrestricted grants from Koehler Chemie, Novartis, Roche, Sandoz; travel support: Astellas, Novartis, Roche, BMS. D.S. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Teva; grants from Astellas, Novartis, Teva, Diaverum, outside of the submitted work. P.T. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Novartis, Pfizer, outside of the submitted work. G.T. reports nonfinancial support from Astellas during the development of this supplement. T.vG. reports nonfinancial support from Astellas during the development of this supplement; nonfinancial support and personal fees from Astellas, Chiesi, Novartis, Teva; grants from Astellas, Chiesi, outside of the submitted work.

Correspondence: James M. Neuberger, MD, FRCP, Liver Unit, Queen Elizabeth Hospital Birmingham, United Kingdom. (jamesneuberger@hotmail.co.uk).

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