ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1973

Treatment Sequences with Romosozumab Before or After Antiresorptive Medication

Felicia Cosman1, David Kendler2, Bente Langdahl3, Benjamin Z Leder4, E Michael Lewiecki5, Akimitsu Miyauchi6, Maria Rojeski7, Michele McDermott7, Mary Oates7, Cassandra E Milmont8, Cesar Libanati9 and Serge Ferrari10, 1Columbia University, New York, NY, 2University of British Columbia, Vancouver, BC, Canada, 3Aarhus University Hospital, Aarhus, Denmark, 4Mass General Hospital, Harvard Medical School, Boston, MA, Boston, MA, 5New Mexico Clinical Research & Osteoporosis Center, Albuquerque, NM, 6Miyauchi Medical Center, Osaka, Japan, 7Amgen Inc., Thousand Oaks, CA, 8Amgen Inc., Thousand Oaks, 9UCB Pharma, Brussels, Belgium, 10Geneva University Hospital, Geneva, Switzerland

Meeting: ACR Convergence 2020

Keywords: ,

Session Information

Date: Monday, November 9, 2020

Session Title: Osteoporosis & Metabolic Bone Disease (1973–1977)

Session Type: Abstract Session

Session Time: 3:00PM-3:50PM

Background/Purpose: Prior studies of anabolic/antiresorptive treatment sequences indicate that using teriparatide first followed by an antiresorptive results in greater bone mineral density (BMD) gains, particularly at the total hip, vs using an antiresorptive first followed by teriparatide (Cosman JBMR 2017). Romosozumab (Romo) increases bone formation while decreasing bone resorption, significantly increasing BMD and reducing fracture risk within 1 year. Here we summarize BMD data with Romo prior to or following an antiresorptive (alendronate [Aln] or denosumab [DMAb]).

Methods: We evaluated percentage change from baseline in BMD at the total hip and lumbar spine from four trials where patients received Romo prior to an antiresorptive (Phase 3 ARCH [Saag NEJM, 2017] and Phase 3 FRAME [Cosman, NEJM 2016]) or Romo following antiresorptive therapy (Phase 3 STRUCTURE [Langdahl, Lancet 2017] and Phase 2 [Kendler, OI 2019]). Percentage change from baseline BMD was assessed by either an ANCOVA (FRAME) or repeated measures (ARCH, STRUCTURE) model adjusting for baseline covariates, or as summary statistics (Phase 2).

Results: Total hip BMD (Figure 1): In ARCH, BMD increased 6.2% with 1 year of Romo, and a total of 7.1% with the 2-year Romo/Aln sequence; and in FRAME, patients gained 6.8% with 1 year of Romo and a total of 8.8% with the 2-year Romo/DMAb sequence. Patients in STRUCTURE, who were previously treated for ≥1 year with Aln, gained 2.9% with 1 year of Romo. In a Phase 2 study, following 1 year of DMAb, 1 year of Romo increased BMD by 0.9%, for a total gain of 3.8% with the 2-year DMAb/Romo sequence.

Lumbar Spine BMD (Figure 2): In ARCH, BMD increased 13.7% with 1 year of Romo, and a total of 15.2% with the 2-year Romo/Aln sequence; and in FRAME, patients gained 13.3% with 1 year of Romo and a total of 17.6% with the 2-year Romo/DMAb sequence. Patients in STRUCTURE (previously on Aln for ≥1 year) gained 9.8% with 1 year of Romo. In the Phase 2 study (after 1 year of DMAb), 1 year of Romo increased BMD by 5.3%, for a total gain of 11.5% with the 2-year DMAb/Romo sequence.

Conclusion: These data demonstrate that treatment with Romo first produces substantial BMD gains at the total hip and lumbar spine within 1 year, and that subsequent transition to a potent antiresorptive can augment those gains. In patients treated with Aln or DMAb, transition to Romo can improve BMD, though gains are not as large as those seen when Romo is used first. Since BMD on treatment is a strong surrogate for bone strength, our findings support the concept that high-risk patients should be offered treatment with Romo first, followed by transition to a potent antiresorptive

Disclosure: F. Cosman, Amgen Inc., 1, 2, 3, Radius Health, 1, 2; D. Kendler, Radius, 1, Amgen Inc., 1, 2, 3, Eli Lilly, 1, 2, Pfizer, 1; B. Langdahl, Amgen Inc., 1, 2, 3, Novo Nordisk, 1, UCB, 1, 2, Eli Lilly, 1, Gedeon-Richter, 1, Gilead, 1; B. Leder, Amgen Inc., 1, 2, Radius, 1; E. Lewiecki, Radius, 1, 2, 3, Amgen Inc., 1, 2, Mereo, 1, Bindex, 1, Alexion, 1, 2, Sandoz, 1, Samsung, 1, Bioepis, 1, Sanifit, 1, University of New Mexico, 1, UpToDate, 1, National Osteoporosis Foundation, International Society for Clinical Densitometry, 1, National Osteoporosis Foundation, International Society for Clinical Densitometry, 1; A. Miyauchi, Amgen Inc., 1, Astellas BioPharma K.K., 1, Teijin Pharma, 1; M. Rojeski, Amgen Inc., 1, 2; M. McDermott, Amgen Inc., 1, 2; M. Oates, Amgen Inc., 1, 2; C. Milmont, Amgen Inc., 1, 2; C. Libanati, UCB Pharma, 1, 2; S. Ferrari, Amgen Inc., 1, 2, UCB, 1, 2, Agnovos, 1, 2, Alexion, 1, Radius, 1, Gideon Richter, 1, Galapagos, 1.

To cite this abstract in AMA style:

Cosman F, Kendler D, Langdahl B, Leder B, Lewiecki E, Miyauchi A, Rojeski M, McDermott M, Oates M, Milmont C, Libanati C, Ferrari S. Treatment Sequences with Romosozumab Before or After Antiresorptive Medication [abstract]. Arthritis Rheumatol. 2020; 72 (suppl 10). https://acrabstracts.org/abstract/treatment-sequences-with-romosozumab-before-or-after-antiresorptive-medication/. Accessed November 25, 2020.

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