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The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
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....
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wiley Periodicals, Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9305881/ https://www.ncbi.nlm.nih.gov/pubmed/34535967 http://dx.doi.org/10.1002/art.41981 |
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author | 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 |
author_facet | 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 |
author_sort | Saag, Kenneth G. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9305881 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Wiley Periodicals, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93058812022-07-28 The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids 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 Arthritis Rheumatol Rheumatoid Arthritis 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. Wiley Periodicals, Inc. 2022-02-13 2022-04 /pmc/articles/PMC9305881/ /pubmed/34535967 http://dx.doi.org/10.1002/art.41981 Text en © 2021 The Authors. Arthritis & Rheumatology published by Wiley Periodicals LLC on behalf of American College of Rheumatology. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Rheumatoid Arthritis 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 The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title | The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title_full | The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title_fullStr | The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title_full_unstemmed | The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title_short | The Effect of Discontinuing Denosumab in Patients With Rheumatoid Arthritis Treated With Glucocorticoids |
title_sort | effect of discontinuing denosumab in patients with rheumatoid arthritis treated with glucocorticoids |
topic | Rheumatoid Arthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9305881/ https://www.ncbi.nlm.nih.gov/pubmed/34535967 http://dx.doi.org/10.1002/art.41981 |
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