Post Hoc Analysis of Levoketoconazole in Patients With Cushing’s Syndrome

James Meyer, PharmD, Senior Director of Publications and Medical Communications at Xeris Pharmaceuticals, discusses a post hoc analysis from a phase 3 study testing levoketoconazole in patients with Cushing’s syndrome.
Cushing's syndrome is a rare endocrine disorder caused by prolonged exposure of the body's tissues to high levels of cortisol. Signs and symptoms of Cushing's syndrome include upper body obesity, fatigue, muscle weakness, high blood pressure, backache, high blood sugar, easy bruising and bluish-red stretch marks on the skin. Affected women may also experience irregular menstrual periods and increased growth of body and facial hair. This condition may be caused by a variety of factors including long-term use of corticosteroid medications, tumors in the pituitary gland or adrenal adenomas.
Current management involves surgical removal of the tumor causing the disease, if that is possible. Medication therapy and radiation therapy may also be part of treatment.
The SONICS clinical trial was a phase 3, open-label, non-randomized, single-arm study evaluating the levoketoconazole in adults with Cushing’s syndrome. A post hoc analysis of the study was presented at ENDO 2024 where patients were split into three groups based on their mean urinary free cortisol (UFC); mild, moderate, and severe at baseline. From the analysis, it was observed that mild and moderate patients had a higher normalization response with lower doses than severe patients. There were also fewer adverse events and discontinuations in the mild and moderate patient groups. The treatment was effective in all three groups.
As Mr. Meyer explains, these results illustrate the need for individualized treatment plans for patients with Cushing’s syndrome.
Chapters:
Cushing's Overview 00:00
Diagnosis and Symptoms 00:45
Current Management 1:23
Post Hoc Analysis Presented at ENDO 2024 1:49