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The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
Author(s) -
Saag Kenneth G.,
McDermott Michele T.,
Adachi Jonathan,
Lems Willem,
Lane Nancy E.,
Geusens Piet,
Stad Robert Kees,
Chen Li,
Huang Shuang,
Dore Robin,
Cohen Stanley
Publication year - 2022
Publication title -
arthritis and rheumatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.106
H-Index - 314
eISSN - 2326-5205
pISSN - 2326-5191
DOI - 10.1002/art.41981
Subject(s) - denosumab , medicine , discontinuation , placebo , n terminal telopeptide , rheumatoid arthritis , osteoporosis , urology , gastroenterology , surgery , pathology , biochemistry , chemistry , alkaline phosphatase , alternative medicine , osteocalcin , enzyme
Objective To evaluate changes in bone turnover and bone mineral density (BMD) in patients with rheumatoid arthritis (RA) receiving glucocorticoids, after discontinuation of denosumab for 12 months. Methods We conducted a randomized, double‐blind, placebo‐controlled, phase II study of RA patients. Patients received placebo, denosumab 60 mg, or denosumab 180 mg every 6 months for 12 months and were followed up for an additional 12 months after discontinuation, during which no bone loss prevention therapy was instituted. Changes from baseline in serum C‐terminal telopeptide of type I collagen (CTX), serum procollagen type I N‐terminal propeptide (PINP), and lumbar spine and total hip BMD were evaluated. Results In this post hoc analysis of patients treated with glucocorticoids at study baseline (n = 82), levels of CTX and PINP decreased significantly from baseline in both denosumab groups. Following denosumab discontinuation, CTX returned to baseline and was not significantly different from the placebo group 6 and 12 months after discontinuation. Median percentage changes from baseline PINP in those treated with denosumab 60 mg were −0.16% and 15.3% at 6 and 12 months, respectively, after discontinuation ( P = 0.062 and P = 0.017, versus placebo); corresponding changes with denosumab 180 mg were 9.0% and 75.8%, respectively ( P = 0.018 and P = 0.002 versus placebo). Compared to placebo, lumbar spine and total hip BMD increased in patients receiving denosumab and returned to baseline 12 months after discontinuation. No osteoporotic fractures were reported during treatment or in the off‐treatment period. Conclusion In this analysis of short‐term denosumab use in RA patients receiving glucocorticoids, denosumab discontinuation resulted in a gradual increase in bone turnover, which was associated with a return to baseline lumbar spine and total hip BMD.