High-dose glucocorticoid treatment vs. glucocorticoid replacement in immune checkpoint inhibitor associated hypophysitis (CORTICI): an open, randomised controlled trial.

ABSTRACT:

Objective

One of the most severe endocrine side effects of immune checkpoint inhibitors (ICI) is hypophysitis leading to adrenal insufficiency. Recovery is rare, although it has been reported after high-dose glucocorticoid treatment. This is the first randomised study to evaluate whether hormonal recovery differs in patients treated with high-dose glucocorticoids versus glucocorticoid replacement therapy.

Design/methods

In this single-centre, open, randomised controlled study, patients with ICI associated hypophysitis were randomised 1:1 to high-dose glucocorticoid treatment (1 mg/kg of prednisolone for two weeks, followed by tapering until week 7 and a switch to hydrocortisone 20 mg total daily dose in week 8) or glucocorticoid replacement therapy (hydrocortisone 20 mg tota

SUBMITTER: Theiler-Schwetz V 

PROVIDER: S-EPMC11770865 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature