OP0297 EFFICACY AND SAFETY OF ROMOSOZUMAB AMONG POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AND MILD-TO-MODERATE CHRONIC KIDNEY DISEASE

Abstract

Objective: To determine if baseline (BL) renal function affects the efficacy and safety of romosozumab (Romo). Materials and Methods: We performed post hoc analyses of 2 Romo trials in postmenopausal women with osteoporosis. In ARCH, 4,093 patients (pts) were randomized 1:1 toRomo 210 mg monthlyor alendronate(ALN) 70mgweekly for 12months (mean age, 74.3; 96.1%with prevalent vertebral fractures [VFx]). In FRAME, 7,180 pts were randomized 1:1 to Romo 210 mg or placebo (Pbo) monthly for 12 months (mean age, 70.9; 18.3% with prevalent VFx). For these analyses, pts were categorized by BL eGFR (mL/min/1.73m2): normal renal function (eGFR ≥ 90), mild renal insufficiency (eGFR 60‐89), or moderate renal insufficiency (eGFR 30‐59). Least squares mean (LSM) % change from BL in BMD at the lumbar spine, total hip, and femoral neck; incidence of new VFx and adverse events (AEs); and changes in renal function were assessed for each eGFR category at month 12 of the double‐blind treatment period. Results: At BL, most pts had mild/moderate renal insufficiency: 84% in ARCH, 88% in FRAME. In both studies, change from BL in BMD was significantly higher in the Romo group across BL eGFR categories (Figure). There was an interaction between BMD increase and renal function, and although BMD increase was less in women with impaired renal function, differences between Romo and control groups remained significant (Figure). Among pts with eGFR ≥ 90, 60‐89, and 30‐59, the incidence of new VFx (Romo vs ALN or Pbo) at month 12 was 3.3% vs 7.3%, 3.2% vs 3.9%, and 3.4% vs 6.2% in ARCH and 0.5% vs 3.0%, 0.4% vs 1.5%, and 0.6% vs 2.1% in FRAME. In both studies, the incidences of AEs and serious AEs were similar in both treatment groups within and across eGFR categories. AEs of mild‐to‐moderate hypocalcemia (investigator reported) occurred in 2 pts (1 Romo [eGFR60‐89], 1 ALN [eGFR ≥ 90]) in ARCH and 1 pt (Romo [eGFR 60‐89]) in FRAME. Five pts (0 Romo, 5 ALN) in ARCH and 19 pts (14 Romo, 5 Pbo) in FRAME had decreases in serum Ca levels (albumin adjusted); in the Romo group all were mild ( < 8.0‐7.0 mg/dL). Similar%of pts in each group had changes in renal function over 12 months of treatment. Conclusion: The efficacy and safety of Romo vs ALN or Pbo was similar among postmenopausal women with osteoporosis and different levels of renal function. Funding: Amgen, Astellas, and UCB Pharma. Disclosures: PM reports consultant/advisory activities for Amgen and Radius Health and has received grants from Amgen, Radius Health, and Ultragenyx; JA is a consultant and speaker for Amgen; BHA has received speaking and consultation fees from Eli Lilly and Amgen;AMC has received honoraria/consultation fees from Eli Lilly and Amgen; AC, MO, NRS, WY, and ZY are employees and stockholders of Amgen; EG reports consultant/speaker's bureau/advisory activities for Amgen, Takeda, Sandoz, and UCB Pharma; BL is on advisory boards for Amgen, UCB Pharma, and Eli Lilly and has received research grants from Amgen and Novo Nordisk; AM has received consulting fees from Amgen, Astellas BioPharma K.K., and Teijin Pharma; IRR has received speaking and consultation fees from Eli Lilly and Amgen; MV is an employee of UCB Pharma.