Interstitial Lung Disease Associated with mTOR Inhibitors in Solid Organ Transplant Recipients: Results from a Large Phase III Clinical Trial Program of Everolimus and Review of the Literature

Joint Authors

Lopez, Patricia
Kohler, Sven
Dimri, Seema

Source

Journal of Transplantation

Issue

Vol. 2014, Issue 2014 (31 Dec. 2014), pp.1-13, 13 p.

Publisher

Hindawi Publishing Corporation

Publication Date

2014-12-17

Country of Publication

Egypt

No. of Pages

13

Main Subjects

Medicine

Abstract EN

Interstitial lung disease (ILD) has been reported with the use of mammalian target of rapamycin inhibitors (mTORi).

The clinical and safety databases of three Phase III trials of everolimus in de novo kidney (A2309), heart (A2310), and liver (H2304) transplant recipients (TxR) were searched using a standardized MedDRA query (SMQ) search for ILD followed by a case-by-case medical evaluation.

A literature search was conducted in MEDLINE and EMBASE.

Out of the 1,473 de novo TxR receiving everolimus in Phase III trials, everolimus-related ILD was confirmed in six cases (one kidney, four heart, and one liver TxR) representing an incidence of 0.4%.

Everolimus was discontinued in three of the four heart TxR, resulting in ILD improvement or resolution.

Outcome was fatal in the kidney TxR (in whom everolimus therapy was continued) and in the liver TxR despite everolimus discontinuation.

The literature review identified 57 publications on ILD in solid organ TxR receiving everolimus or sirolimus.

ILD presented months or years after mTORi initiation and symptoms were nonspecific and insidious.

The event was more frequent in patients with a late switch to mTORi.

In most cases, ILD was reversed after prompt mTORi discontinuation.

ILD induced by mTORi is an uncommon and potentially fatal event warranting early recognition and drug discontinuation.

American Psychological Association (APA)

Lopez, Patricia& Kohler, Sven& Dimri, Seema. 2014. Interstitial Lung Disease Associated with mTOR Inhibitors in Solid Organ Transplant Recipients: Results from a Large Phase III Clinical Trial Program of Everolimus and Review of the Literature. Journal of Transplantation،Vol. 2014, no. 2014, pp.1-13.
https://search.emarefa.net/detail/BIM-1043286

Modern Language Association (MLA)

Lopez, Patricia…[et al.]. Interstitial Lung Disease Associated with mTOR Inhibitors in Solid Organ Transplant Recipients: Results from a Large Phase III Clinical Trial Program of Everolimus and Review of the Literature. Journal of Transplantation No. 2014 (2014), pp.1-13.
https://search.emarefa.net/detail/BIM-1043286

American Medical Association (AMA)

Lopez, Patricia& Kohler, Sven& Dimri, Seema. Interstitial Lung Disease Associated with mTOR Inhibitors in Solid Organ Transplant Recipients: Results from a Large Phase III Clinical Trial Program of Everolimus and Review of the Literature. Journal of Transplantation. 2014. Vol. 2014, no. 2014, pp.1-13.
https://search.emarefa.net/detail/BIM-1043286

Data Type

Journal Articles

Language

English

Notes

Includes bibliographical references

Record ID

BIM-1043286