Two-year data support denosumab use in patients with glucocorticoid-induced osteoporosis
medwireNews: Greater increases in bone mineral density (BMD) seen with denosumab versus risedronate in glucocorticoid-treated patients with osteoporosis are sustained through 24 months, indicate phase III data.
Presented at the 2018 ACR/ARHP Annual Meeting in Chicago, Illinois, USA, the findings expand on the previously published 12-month data and show that denosumab continues to increase total hip and lumbar spine BMD significantly more than risedronate for a further 12 months in both patients initiating glucocorticoid treatment and those continuing on the treatment.
“Treatment differences at all skeletal sites were larger at 24 months than at 12 months,” lead author Kenneth Saag, from the University of Alabama at Birmingham, USA, told delegates.
Of 795 patients with disorders including rheumatoid arthritis, polymyalgia rheumatica, and systemic lupus erythematosus who were initially randomly assigned to treatment, 74.2% completed the 24-month study. Of these, 295 were taking denosumab subcutaneously 60 mg once every 6 months (109 patients initiating glucocorticoids and 186 continuing glucocorticoids) and 295 were taking oral risedronate 5 mg/day (117 glucocorticoid initiators and 178 glucocorticoid continuers).
The percentage change in lumbar spine BMD from baseline was about 6.0% in patients taking denosumab compared with about 1.5% in patients taking risedronate among initiators of glucocorticoids (prednisone at a dose of at least 7.5 mg or equivalent) and about 6.5% versus 3.0% among patients continuing glucocorticoid treatment.
The percentage change in total hip BMD in glucocorticoid initiators was about 3.0% versus 0.0% with denosumab and risedronate, respectively, and about 2.9% versus 0.5% in glucocorticoid continuers.
Saag noted that suppression in bone turnover markers initially occurred to a greater degree in patients taking denosumab, but by 1 year the rates in the two treatment groups had converged and by 2 years there was no significant difference.
The rate of adverse events, serious adverse events, treatment-emergent events, and adverse events leading to treatment discontinuation were largely similar between the two groups.
The number of serious infections in the patients remained small and did not differ significantly between the treatment groups, irrespective of whether they were taking concomitant biologic or immunosuppressant medications. Similarly, the risk for fracture did not differ significantly according to treatment at either 12 or 24 months.
Saag concluded that “denosumab may offer a valuable osteoporosis treatment option for patients receiving glucocorticoids.”
By Lucy Piper
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