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2016 ; 20
(62
): 1-594
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Immunosuppressive therapy for kidney transplantation in adults: a systematic
review and economic model
#MMPMID27578428
Jones-Hughes T
; Snowsill T
; Haasova M
; Coelho H
; Crathorne L
; Cooper C
; Mujica-Mota R
; Peters J
; Varley-Campbell J
; Huxley N
; Moore J
; Allwood M
; Lowe J
; Hyde C
; Hoyle M
; Bond M
; Anderson R
Health Technol Assess
2016[Aug]; 20
(62
): 1-594
PMID27578428
show ga
BACKGROUND: End-stage renal disease is a long-term irreversible decline in kidney
function requiring renal replacement therapy: kidney transplantation,
haemodialysis or peritoneal dialysis. The preferred option is kidney
transplantation, followed by immunosuppressive therapy (induction and maintenance
therapy) to reduce the risk of kidney rejection and prolong graft survival.
OBJECTIVES: To review and update the evidence for the clinical effectiveness and
cost-effectiveness of basiliximab (BAS) (Simulect(®), Novartis Pharmaceuticals UK
Ltd) and rabbit anti-human thymocyte immunoglobulin (rATG) (Thymoglobulin(®),
Sanofi) as induction therapy, and immediate-release tacrolimus (TAC) (Adoport(®),
Sandoz; Capexion(®), Mylan; Modigraf(®), Astellas Pharma; Perixis(®), Accord
Healthcare; Prograf(®), Astellas Pharma; Tacni(®), Teva; Vivadex(®), Dexcel
Pharma), prolonged-release tacrolimus (Advagraf(®) Astellas Pharma), belatacept
(BEL) (Nulojix(®), Bristol-Myers Squibb), mycophenolate mofetil (MMF) (Arzip(®),
Zentiva; CellCept(®), Roche Products; Myfenax(®), Teva), mycophenolate sodium
(MPS) (Myfortic(®), Novartis Pharmaceuticals UK Ltd), sirolimus (SRL)
(Rapamune(®), Pfizer) and everolimus (EVL) (Certican(®), Novartis) as maintenance
therapy in adult renal transplantation. METHODS: Clinical effectiveness searches
were conducted until 18 November 2014 in MEDLINE (via Ovid), EMBASE (via Ovid),
Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web
of Science (via ISI), Cochrane Database of Systematic Reviews, Database of
Abstracts of Reviews of Effects and Health Technology Assessment (The Cochrane
Library via Wiley Online Library) and Health Management Information Consortium
(via Ovid). Cost-effectiveness searches were conducted until 18 November 2014
using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE
(via Ovid), NHS Economic Evaluation Database (via Wiley Online Library), Web of
Science (via ISI), Health Economic Evaluations Database (via Wiley Online
Library) and the American Economic Association's electronic bibliography (via
EconLit, EBSCOhost). Included studies were selected according to predefined
methods and criteria. A random-effects model was used to analyse clinical
effectiveness data (odds ratios for binary data and mean differences for
continuous data). Network meta-analyses were undertaken within a Bayesian
framework. A new discrete time-state transition economic model (semi-Markov) was
developed, with acute rejection, graft function (GRF) and new-onset diabetes
mellitus used to extrapolate graft survival. Recipients were assumed to be in one
of three health states: functioning graft, graft loss or death. RESULTS:
Eighty-nine randomised controlled trials (RCTs), of variable quality, were
included. For induction therapy, no treatment appeared more effective than
another in reducing graft loss or mortality. Compared with placebo/no induction,
rATG and BAS appeared more effective in reducing biopsy-proven acute rejection
(BPAR) and BAS appeared more effective at improving GRF. For maintenance therapy,
no treatment was better for all outcomes and no treatment appeared most effective
at reducing graft loss. BEL?+?MMF appeared more effective than TAC?+?MMF and
SRL?+?MMF at reducing mortality. MMF?+?CSA (ciclosporin), TAC?+?MMF, SRL?+?TAC,
TAC?+?AZA (azathioprine) and EVL?+?CSA appeared more effective than CSA?+?AZA and
EVL?+?MPS at reducing BPAR. SRL?+?AZA, TAC?+?AZA, TAC?+?MMF and BEL?+?MMF
appeared to improve GRF compared with CSA?+?AZA and MMF?+?CSA. In the base-case
deterministic and probabilistic analyses, BAS, MMF and TAC were predicted to be
cost-effective at £20,000 and £30,000 per quality-adjusted life-year (QALY). When
comparing all regimens, only BAS?+?TAC?+?MMF was cost-effective at £20,000 and
£30,000 per QALY. LIMITATIONS: For included trials, there was substantial
methodological heterogeneity, few trials reported follow-up beyond 1 year, and
there were insufficient data to perform subgroup analysis. Treatment
discontinuation and switching were not modelled. FUTURE WORK: High-quality,
better-reported, longer-term RCTs are needed. Ideally, these would be
sufficiently powered for subgroup analysis and include health-related quality of
life as an outcome. CONCLUSION: Only a regimen of BAS induction followed by
maintenance with TAC and MMF is likely to be cost-effective at £20,000-30,000 per
QALY. STUDY REGISTRATION: This study is registered as PROSPERO CRD42014013189.
FUNDING: The National Institute for Health Research Health Technology Assessment
programme.
|Abatacept/economics/therapeutic use
[MESH]
|Antibodies, Monoclonal
[MESH]
|Antilymphocyte Serum
[MESH]
|Basiliximab
[MESH]
|Bayes Theorem
[MESH]
|Cost-Benefit Analysis
[MESH]
|Everolimus/economics/therapeutic use
[MESH]
|Graft Rejection/prevention & control
[MESH]
|Humans
[MESH]
|Immunosuppressive Agents/administration & dosage/adverse
effects/*economics/*therapeutic use
[MESH]
|Kidney Failure, Chronic/*surgery
[MESH]
|Kidney Transplantation/*methods
[MESH]
|Models, Economic
[MESH]
|Mycophenolic Acid/economics/therapeutic use
[MESH]
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