Efficacy and Safety of Basiliximab in Pediatric Renal Transplant Patients Receiving Cyclosporine, Mycophenolate Mofetil, and Steroids

Offner, G.; Toenshoff, Burkhard; Höcker, Britta; Krauss, Manuela; Bulla, M; Cochat, Pierre; Fehrenbach, Henry; Fischer, Wolfgang; Foulard, M; Höppe, Bernd; Hoyer, Peter F.; Jungraithmayr, Therese; Klaus, Günter; Latta, Kay; Leichter, Heinz E.; Mihatsch, Michael J.; Misselwitz, Joachim; Montoya, Carmen; Neuhaus, Thomas J.; Pape, Lars; Querfeld, Uwe; Plank, Christian; Schwarke, D; Wygoda, Simone; Zimmerhackl, Lothar Bernd

doi:10.1097/tp.0b013e318188af15

Cited by 64 publications

(96 citation statements)

References 26 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…In summary, three RCTs (published in seven papers [73][74][75][76][77][78][79] and one abstract 72 ) were found eligible and are included in this review (Table 10). • Abstract, n = 332…”

Section: Randomised Control Trialsmentioning

confidence: 99%

“…77,90 Additional publications of Grenda et al 90 were identified in our searches (the previous HTA included only 6-month follow-up data; see Table 12). We identified one new RCT 73 that was not included in Yao et al Non-randomised studies…”

Section: Randomised Control Trialsmentioning

confidence: 99%

“…This abstract included new data related to Offner et al 73 and sufficient methodological information to inform the quality appraisal. In addition, there were 23 articles that were systematic reviews and all eligible systematic reviews were tabulated (see Appendix 3, Table 137).…”

Section: Randomised Control Trialsmentioning

confidence: 99%

“…Although RCTs in mixed populations were identified, none included subgroup analysis by age -providing separate results for children/adolescents and adultsand were therefore excluded from the review (a list of these records can be found in Appendix 2, Table 136). Three RCTs (published in one abstract 72 and seven papers [73][74][75][76][77][78][79] ) met the inclusion criteria.…”

Section: Randomised Control Trialsmentioning

confidence: 99%

“…Random allocation: the method of random allocation, including the method of sequence generation, was clearly stated and adequate in only one trial 73 and unclear in the other two trials. 75,77 Concealment of allocation: the method of concealment of allocation was clearly reported in only one trial 77 and unclear in the other two trials.…”

Section: Treatment Allocationmentioning

confidence: 99%

See 4 more Smart Citations

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

Haasova

Snowsill

Jones-Hughes

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

BackgroundEnd-stage renal disease is a long-term irreversible decline in kidney function requiring kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation followed by induction and maintenance immunosuppressive therapy to reduce the risk of kidney rejection and prolong graft survival.ObjectivesTo systematically review and update the evidence for the clinical effectiveness and cost-effectiveness of basiliximab (BAS) (Simulect,®Novartis Pharmaceuticals) and rabbit antihuman thymocyte immunoglobulin (Thymoglobuline,®Sanofi) as induction therapy and immediate-release tacrolimus [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), generic MMF is manufactured by Accord Healthcare, Actavis, Arrow Pharmaceuticals, Dr Reddy’s Laboratories, Mylan, Sandoz and Wockhardt], mycophenolate sodium, sirolimus (Rapamune,®Pfizer) and everolimus (Certican,®Novartis Pharmaceuticals) as maintenance therapy in children and adolescents undergoing renal transplantation.Data sourcesClinical effectiveness searches were conducted to 7 January 2015 in MEDLINE (via Ovid), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (via Wiley Online Library) and Web of Science [via Institute for Scientific Information (ISI)], Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects and Health Technology Assessment (HTA) (The Cochrane Library via Wiley Online Library) and Health Management Information Consortium (via Ovid). Cost-effectiveness searches were conducted to 15 January 2015 using a costs or economic literature search filter in MEDLINE (via Ovid), EMBASE (via Ovid), NHS Economic Evaluation Databases (via Wiley Online Library), Web of Science (via ISI), Health Economic Evaluations Database (via Wiley Online Library) and EconLit (via EBSCOhost).Review methodsTitles and abstracts were screened according to predefined inclusion criteria, as were full texts of identified studies. Included studies were extracted and quality appraised. Data were meta-analysed when appropriate. A new discrete time state transition economic model (semi-Markov) was developed; graft function, and incidences of acute rejection and new-onset diabetes mellitus were used to extrapolate graft survival. Recipients were assumed to be in one of three health states: functioning graft, graft loss or death.ResultsThree randomised controlled trials (RCTs) and four non-RCTs were included. The RCTs only evaluated BAS and tacrolimus (TAC). No statistically significant differences in key outcomes were found between BAS and placebo/no induction. Statistically significantly higher graft function (p < 0.01) and less biopsy-proven acute rejection (odds ratio 0.29, 95% confidence interval 0.15 to 0.57) was found between TAC and ciclosporin (CSA). Only one cost-effectiveness study was identified, which informed NICE guidance TA99. BAS [with TAC and azathioprine (AZA)] was predicted to be cost-effective at £20,000–30,000 per quality-adjusted life year (QALY) versus no induction (BAS was dominant). BAS (with CSA and MMF) was not predicted to be cost-effective at £20,000–30,000 per QALY versus no induction (BAS was dominated). TAC (with AZA) was predicted to be cost-effective at £20,000–30,000 per QALY versus CSA (TAC was dominant). A model based on adult evidence suggests that at a cost-effectiveness threshold of £20,000–30,000 per QALY, BAS and TAC are cost-effective in all considered combinations; MMF was also cost-effective with CSA but not TAC.LimitationsThe RCT evidence is very limited; analyses comparing all interventions need to rely on adult evidence.ConclusionsTAC is likely to be cost-effective (vs. CSA, in combination with AZA) at £20,000–30,000 per QALY. Analysis based on one RCT found BAS to be dominant, but analysis based on another RCT found BAS to be dominated. BAS plus TAC and AZA was predicted to be cost-effective at £20,000–30,000 per QALY when all regimens were compared using extrapolated adult evidence. High-quality primary effectiveness research is needed. The UK Renal Registry could form the basis for a prospective primary study.Study registrationThis study is registered as PROSPERO CRD42014013544.FundingThe National Institute for Health Research HTA programme.

show abstract

“…In summary, three RCTs (published in seven papers [73][74][75][76][77][78][79] and one abstract 72 ) were found eligible and are included in this review (Table 10). • Abstract, n = 332…”

Section: Randomised Control Trialsmentioning

confidence: 99%

Section: Randomised Control Trialsmentioning

confidence: 99%

Section: Randomised Control Trialsmentioning

confidence: 99%

Section: Randomised Control Trialsmentioning

confidence: 99%

Section: Treatment Allocationmentioning

confidence: 99%

See 3 more Smart Citations

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

Haasova

Snowsill

Jones-Hughes

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

show abstract

Interleukin 2 receptor antagonists for kidney transplant recipients

Webster

Ruster

McGee

et al. 2010

Cochrane Database of Systematic Reviews

143

View full text Add to dashboard Cite

Given a 38% risk of rejection, per 100 recipients compared with no treatment, nine recipients would need treatment with IL2Ra to prevent one recipient having rejection, 42 to prevent one graft loss, and 38 to prevent one having CMV disease over the first year post-transplantation. Compared with ATG treatment, ATG may prevent some experiencing acute rejection, but 16 recipients would need IL2Ra to prevent one having CMV, but 58 would need IL2Ra to prevent one having malignancy. There are no apparent differences between basiliximab and daclizumab. IL2Ra are as effective as other antibody therapies and with significantly fewer side effects.

show abstract

Renal Transplantation in Children

Berardinelli¹,

Ghio²

2012

Handbook of Renal and Pancreatic Transplantation

View full text Add to dashboard Cite

Efficacy and Safety of Basiliximab in Pediatric Renal Transplant Patients Receiving Cyclosporine, Mycophenolate Mofetil, and Steroids

Cited by 64 publications

References 26 publications

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

Immunosuppressive therapy for kidney transplantation in children and adolescents: systematic review and economic evaluation

Interleukin 2 receptor antagonists for kidney transplant recipients

Renal Transplantation in Children

Contact Info

Product

Resources

About