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Abstract Number: 1876

Effect of Discontinuation of Denosumab in Subjects with Rheumatoid Arthritis Treated with Glucocorticoids

Kenneth Saag1, Michele McDermott 2, Jonathan Adachi 3, Willem Lems 4, Nancy Lane 5, Piet Geusens 6, Peter Butler 2, Li Chen 2, Daria Crittenden 2, Robin Dore 7 and Stanley Cohen 8, 1University of Alabama, Birmingham, AL, 2Amgen Inc., Thousand Oaks, CA, 3McMaster University and St. Joseph's Healthcare Hamilton, Hamilton, ON, Canada, 4VU University Medical Centre, Amsterdam, Netherlands, 5University of California at Davis Medical Center, Sacramento, CA, 6Maastricht University, Maastricht, Netherlands, 7Robin K Dore Inc, Tustin, CA, 8Metroplex Clinical Research Center, Dallas, TX

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: bone turnover markers and bone density, denosumab, glucocorticoids, Rheumatoid arthritis (RA)

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Session Information

Date: Monday, November 11, 2019

Session Title: 4M114: Osteoporosis & Metabolic Bone Disease – Basic & Clinical Science (1872–1877)

Session Type: ACR Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: Denosumab, a monoclonal antibody against RANKL, is approved for the treatment of glucocorticoid (GC) induced osteoporosis (GiOP). In postmenopausal women with osteoporosis, denosumab discontinuation leads to a transient increase in bone turnover above baseline, peaking at 12 months from the last dose, and a corresponding decline in bone mineral density (BMD). To better understand the effects of denosumab discontinuation in GC-treated patients, we analyzed a subgroup receiving GCs at baseline from a phase 2 study of denosumab in subjects with rheumatoid arthritis (RA), followed for 12 months after denosumab discontinuation, for changes in bone turnover and BMD. (Ann Rheum Dis, vol 8, suppl 2, yr 2019, pg A931)

Methods: This double-blind, placebo-controlled study enrolled subjects with RA who were randomized to receive denosumab 60 mg, denosumab 180 mg, or placebo subcutaneously for 12 months, and followed for progression of structural damage. Subjects were followed for an additional 12 months after denosumab discontinuation. Outcome measures in this subgroup analysis of subjects treated with GCs at study baseline included percent change from baseline in serum C-terminal telopeptide of type I collagen (CTX) and lumbar spine (LS) and total hip (TH) BMD on- and off-treatment. Baseline mean (SD) prednisone equivalent dose (mg/day) was 6.1 (2.4), 5.2 (2.1), and 6.1 (3.2) in the placebo, denosumab 60 mg, and denosumab 180 mg groups, respectively. Data on CTX are reported as median and interquartile range. Percent changes in LS and TH BMD at each time point were assessed based on a repeated-measures model adjusting for treatment, baseline use of steroids, previous use of biologics, and baseline BMD value.

Results: Among 218 subjects in the phase 2 study, 82 (26 placebo, 27 denosumab 60 mg, and 29 denosumab 180 mg) were included in this analysis. After 12 months of denosumab treatment, CTX decreased from baseline in both groups (Figure); in the off-treatment period, CTX returned to baseline by 18 months and was overall similar to placebo at 24 months. BMD increased at the LS and TH at 12 months with denosumab treatment (Figure) and returned to baseline levels after 12 months of discontinuation.

Conclusion: Like all non-bisphosphonate medications for osteoporosis, denosumab is reversible with discontinuation. In this small subgroup of GC-treated subjects with RA, BMD gains achieved with denosumab were lost upon discontinuation, consistent with observations in postmenopausal women receiving denosumab for osteoporosis. In this analysis of short-term denosumab use in subjects with RA receiving GCs, bone turnover was reduced with denosumab and gradually returned to baseline upon discontinuation, without a clear increase to above-baseline levels in the off-treatment period.

Change in CTX, Lumbar Spine BMD, and Total Hip BMD from Baseline Upon Denosumab Discontinuation in Patients with Rheumatoid Arthritis


Disclosure: K. Saag, Amgen Inc., 2, 5, Radius, 5, Roche, 5; M. McDermott, Amgen Inc., 1, 3; J. Adachi, Abbvie, 2, Amgen, 2, 5, 8, Amgen Inc., 2, 5, 8, Eli Lilly, 5, Lilly, 5, Pfizer, 2, UCB, 2; W. Lems, Amgen Inc., 8, Lilly, 8, Merck, 8, Pfizer, 8; N. Lane, Amgen Inc., 5, 8, GSK, 5, Radius Health, Inc., 8; P. Geusens, AbbVie, 2, 5, 8, Amgen Inc., 2, 5, 8, BMS, 2, 5, 8, Celgene, 2, 5, 8, Lilly, 2, 5, 8, Janssen, 2, 5, 8, MSD, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, Roche, 2, 5, 8, Sanofi, 2, 5, 8, UCB Pharma, 2, 5, 8, Will, 2, 5, 8; P. Butler, Amgen Inc., 1, 3, 9; L. Chen, Amgen Inc., 1, 3; D. Crittenden, Amgen Inc., 1, 9; R. Dore, AbbVie, 2, 5, 8, Amgen Inc., 2, 5, 8, Biogen, 2, Gilead, 2, 5, Lilly, 2, 5, 8, Novartis, 2, 5, 8, Pfizer, 2, 5, 8, UCB Pharma, 2, 5, 8, BMS, 5, 8, Radius, 5, 8; S. Cohen, AbbVie, 2, 5, Abbvie, 5, Amgen, 5, Amgen Inc., 2, 5, AstraZeneca, 2, 5, Biogen-IDEC, 2, 5, Bristol Meyer Squibb, 2, 5, Genentech, 2, 5, Janssen, 2, 5, Lilly, 2, 5, Merck, 2, 5, Novartis, 2, 5, Pfizer, 2, 5, Roche, 2, 5.

To cite this abstract in AMA style:

Saag K, McDermott M, Adachi J, Lems W, Lane N, Geusens P, Butler P, Chen L, Crittenden D, Dore R, Cohen S. Effect of Discontinuation of Denosumab in Subjects with Rheumatoid Arthritis Treated with Glucocorticoids [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/effect-of-discontinuation-of-denosumab-in-subjects-with-rheumatoid-arthritis-treated-with-glucocorticoids/. Accessed January 21, 2021.
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