Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: We previously demonstrated that denosumab increased lumbar spine and total hip bone mineral density (BMD) significantly more than risedronate at 12 and 24 months in glucocorticoid (GC)-treated individuals (Saag ACR 2016; Saag ECTS 2018). Prespecified subgroup analyses of lumbar spine BMD at 12 months indicated that denosumab was superior to risedronate across 7 subgroups of GC-treated individuals (Saag ASBMR 2017). This analysis explored the effects of denosumab and risedronate on lumbar spine BMD in the same subgroups of GC-treated individuals at 24 months.
Methods: The phase 3, randomized, double-blind, double-dummy, active-controlled study enrolled women and men age ≥18 years receiving ≥7.5 mg prednisone or equivalent daily for <3 months (GC-initiating) or ≥3 months (GC-continuing) before screening. All subjects age <50 years were required to have a history of osteoporotic fracture. GC–continuing subjects age ≥50 years were required to have lumbar spine, total hip, or femoral neck BMD T‑score ≤‒2.0; or ≤‒1.0 with a history of osteoporotic fracture. Subjects were randomized 1:1 to denosumab 60 mg SC every 6 months or risedronate 5 mg PO daily for 24 months. All subjects were to receive daily calcium (≥1000 mg) and vitamin D (≥800 IU). The treatment difference (denosumab – risedronate) for percentage change from baseline in lumbar spine BMD at 24 months was estimated in the GC-initiating and GC-continuing subpopulations, both overall and in 7 prespecified subgroups where treatment effect might differ (sex, race, age, baseline BMD T‑score, geographic region, menopausal status, and baseline GC daily dose).
Results: The study enrolled 795 subjects (290 GC-initiating, 505 GC-continuing). Baseline characteristics were balanced between treatment groups within each subpopulation. Denosumab was superior to risedronate for gains in lumbar spine BMD at 24 months in both the GC-initiating and GC-continuing subpopulations. Within each subgroup (Table), denosumab was consistently associated with a greater increase in lumbar spine BMD at 24 months compared with risedronate. Significant quantitative interactions were observed only in the sex and race subgroups in the GC-initiating subpopulation. However, qualitative tests indicated the direction of the denosumab effect did not differ significantly by sex or race in this subpopulation.
Conclusion: Denosumab consistently increased lumbar spine BMD more than risedronate at 24 months in both GC-initiating and GC-continuing subpopulations, with no evidence of directional heterogeneity in treatment effect across 7 prespecified subgroups of GC-treated individuals. Denosumab may be a useful addition to the osteoporosis armamentarium in the common clinical setting of GC use.
To cite this abstract in AMA style:Saag K, Pannacciulli N, Geusens P, Adachi JD, Lespessailles E, Malouf J, Langdahl B, Butler PW, Yin X, Lems WF. Subgroup Analysis of the Effect of Denosumab Compared with Risedronate on Percentage Change in Lumbar Spine Bone Mineral Density at 24 Months in Glucocorticoid-Treated Individuals [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/subgroup-analysis-of-the-effect-of-denosumab-compared-with-risedronate-on-percentage-change-in-lumbar-spine-bone-mineral-density-at-24-months-in-glucocorticoid-treated-individuals/. Accessed October 25, 2021.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/subgroup-analysis-of-the-effect-of-denosumab-compared-with-risedronate-on-percentage-change-in-lumbar-spine-bone-mineral-density-at-24-months-in-glucocorticoid-treated-individuals/