High-dose glucocorticoid treatment was not effective in restoring adrenal function in ICI-associated hypophysitis and leads to adverse effects on glucose metabolism, therefore the authors do not recommend its use except for compressive symptoms.
Key Findings
Results
No patients in either treatment group experienced recovery of adrenal function.
18 out of 20 randomised patients finished the trial; eight completed high-dose glucocorticoid treatment and 10 completed glucocorticoid replacement therapy.
The primary outcome was the frequency of hormonal axes recovery.
None of the patients in neither group experienced a recovery in adrenal function.
Recovery of adrenal function was the primary endpoint assessed over 8 weeks of treatment.
Results
High-dose glucocorticoid treatment had a significant unfavourable effect on HbA1c compared to glucocorticoid replacement therapy.
Mean treatment effect on HbA1c was 5.16 (95% confidence interval 0.31 to 10.02, p = 0.039).
This adverse effect on glucose metabolism was statistically significant.
High-dose treatment consisted of 1 mg/kg of prednisolone for two weeks, followed by tapering until week 7, then switch to hydrocortisone 20 mg total daily dose in week 8.
Glucocorticoid replacement therapy consisted of hydrocortisone 20 mg total daily dose throughout the 8-week period.
Results
Only one patient in each group showed amelioration of hypogonadism, with no other hormonal axis recovery observed.
Six patients had an additional hormone deficiency beyond adrenal insufficiency.
One patient in the high-dose group and one patient in the replacement group showed amelioration of hypogonadism.
No other hormonal axes recovery was documented in either group.
Results
The patient population presented with a range of clinical features characteristic of ICI-associated hypophysitis.
Nine patients presented with hyponatraemia.
Only two patients had typical changes on MRI.
12 patients had isolated adrenal insufficiency.
Six patients had an additional hormone deficiency beyond adrenal insufficiency.
Patients were enrolled between 17th April 2019 and 16th September 2022 in a single-centre study.
Background
This was the first randomised controlled study to evaluate whether hormonal recovery differs between high-dose glucocorticoid treatment and glucocorticoid replacement therapy in ICI-associated hypophysitis.
The study used an open, randomised controlled design with 1:1 randomisation.
20 patients were randomised; 18 completed the trial.
The study was conducted at a single centre.
Recovery of adrenal function has been reported after high-dose glucocorticoid treatment in prior case reports, motivating the trial design.