Interstitial pneumonitis caused by everolimus: a case-cohort study in renal transplant recipients.
Baas MC, Struijk GH, et al.Transplant International 2014; 27(5): 428-436
Aims
This sub study presented as part of a larger study evaluating the effects of cyclosporine A (CsA) withdrawal from an immunosuppressive regimen containing basiliximab, CsA, prednisolone (P) and mycopheonolate sodium (MPS) after transplantation. The sub study aims to describe the incidence and risk factors of everolimus induced pneumonitis (EIP) in kidney transplant recipients.
Interventions
The larger trial evaluated conversion from the quadruple regimen to P/CsA, P/MPS or P/everolimus. The substudy included participants who were randomised to P/everolimus.
Participants
102 renal transplant recipients.
Outcomes
The primary outcome included interstitial graft fibrosis and hyalinosis. The secondary outcome was graft rejection.
Follow-up
1 year.
CET Conclusions
This is a retrospective analysis of results from a previously published trial. This paper aimed to evaluate risk factors for developing Everolimus associated Interstitial Pneumonitis (EIP). The retrospective analysis included patients who were randomised to the Everolimus arm of the study and those that received Everolimus despite randomisation to a different arm. This small cohort (102 patients) had a 12.7% risk of developing EIP (13 patients) over a satisfactory follow up. This is the largest case series of EIP in solid organ transplantation, however the number of cases is still small and the paper therefore fails to elucidate the risk factors for developing EIP and the pathophysiology of the condition.
Data analysis
Modified intention-to-treat analysis
Quality notes
Previously assessed in Bemelman FJ, de Maar EF, Press RR et al. Minimization of maintenance immunosuppression early after renal transplantation: an interim analysis. Transplantation 2009; 88: 421
Trial registration
Dutch Registry Trial Registration Number: NTR567, ISRCTN69188731