Impact of Osilodrostat on Health‐Related Quality of Life in Cushing's Disease: Analysis of Patient‐Reported Outcomes From the Phase III LINC 3 and LINC 4 Clinical Trials
Authors' conclusion
Osilodrostat improved HRQoL, with clinically meaningful, consistent improvements across HRQoL assessments.
Study context
- Population
- Patients with CD; mean baseline total scores: CushingQoL 44.0, BDI-II 15.6, EQ-5D-5L 0.7
- Participants
- 185 patients
- Outcome
- Changes from baseline in CushingQoL, BDI-II and EQ-5D-5L scores
Methodological detailspatient-reported outcomes
- Patient-reported outcomes
Pooled result
As reported in the abstract
Change from baseline in HRQoL scores
- Mean CushingQoL score improvement, W12 (all p < 0.001)
- +7.72
- Mean CushingQoL score improvement, W26 (achieving MCID) (all p < 0.001)
- +11.45
- Mean CushingQoL score improvement, W72 (all p < 0.001)
- +15.32
- Mean BDI-II score improvement, W12 (achieving MCID) (all p < 0.001)
- −19.0%
- Mean BDI-II score improvement, W72 (all p < 0.001)
- −41.2%
- EQ-5D-5L utility score improved over W26-72, reaching MCID range at W26
- p < 0.01
Further pooled results
Health-related quality of life (HRQoL) questionnaire items/domains
- All items/domains significantly improved over time (ordinal mixed-effects regression), except one BDI-II item (past failure) and one EQ-5D-5L domain (self-care)
- P < 0.001
HRQoL by hypercortisolism severity
- CushingQoL total score improved in mild (mUFC ≤2x ULN), moderate (mUFC >2-5 × ULN) and severe (mUFC >5 × ULN) hypercortisolism
- BDI-II and EQ-5D-5L total scores improved in moderate and severe hypercortisolism
Multivariable models of CushingQoL
- Longer treatment duration associated with CushingQoL improvements; higher mUFC, higher BMI and occurrence of HAEs associated with lower CushingQoL scores
Safety
Hypocortisolism-related adverse events (HAEs) and HRQoL
- Grade 3 HAEs temporarily reduced CushingQoL and EQ-5D-3L scores during event weeks
Original publication
Impact of Osilodrostat on Health‐Related Quality of Life in Cushing's Disease: Analysis of Patient‐Reported Outcomes From the Phase III LINC 3 and LINC 4 Clinical Trials. Clin Endocrinol (Oxf). Published 1 June 2026. doi:10.
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