Impact of oral glucocorticoids on the effectiveness of romosozumab: the multicenter OASIS cohort study.

UNLABELLED: This multicenter retrospective cohort compared romosozumab outcomes between oral glucocorticoid users and non-users. Bone turnover marker responses and lumbar spine bone mineral density gains were similar, whereas total hip bone mineral density gains were smaller among glucocorticoid users.

PURPOSE: To investigate the impact of oral glucocorticoids (GC) on the effectiveness of romosozumab by comparing outcomes between GC users and non-users after adjusting for patient background.

METHODS

This multicenter, retrospective cohort study analyzed patients who completed 12 months of therapy (n = 428). Inverse probability of treatment weighting was employed to construct a pseudo-population with balanced baseline characteristics, yielding 40 GC users and 39.8 non-users (95.3% female, mean age 76.6 years; mean lumbar spine T-score -2.7; mean GC dose 5.4 mg/day [prednisolone equivalent]). Percentage changes in bone turnover markers (BTMs) and bone mineral density (BMD) over 12 months were compared between groups. Factors affecting BMD changes were identified using multivariable analysis.

RESULTS

GC use did not significantly affect the changes in PINP and TRACP-5b levels. The 12-month increase in lumbar spine BMD was comparable between groups (GC users 9.7% vs. non-users 10.7%; P = 0.55). In contrast, the increase in total hip BMD was significantly lower in GC users compared with non-users (2.8% vs. 5.6%; P = 0.003). Multivariable analysis revealed that baseline PINP was significantly associated with the BMD increase at the lumbar spine, whereas daily GC dose was a significant factor for the total hip.

CONCLUSION

Oral GC use did not significantly affect changes in BTMs or BMD increases at the lumbar spine. Smaller gains in total hip BMD were observed in GC users, which may have reflected not only GC use but also underlying disease-related factors.