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Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study
OBJECTIVES: This study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day. METHODS: Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patie...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352419/ https://www.ncbi.nlm.nih.gov/pubmed/30194275 http://dx.doi.org/10.1136/annrheumdis-2018-213271 |
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author | Takeuchi, Tsutomu Genovese, Mark C Haraoui, Boulos Li, Zhanguo Xie, Li Klar, Rena Pinto-Correia, Ana Otawa, Susan Lopez-Romero, Pedro de la Torre, Inmaculada Macias, William Rooney, Terence P Smolen, Josef S |
author_facet | Takeuchi, Tsutomu Genovese, Mark C Haraoui, Boulos Li, Zhanguo Xie, Li Klar, Rena Pinto-Correia, Ana Otawa, Susan Lopez-Romero, Pedro de la Torre, Inmaculada Macias, William Rooney, Terence P Smolen, Josef S |
author_sort | Takeuchi, Tsutomu |
collection | PubMed |
description | OBJECTIVES: This study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day. METHODS: Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4 mg for ≥15 months and maintained CDAI low disease activity (LDA) or remission (REM) were blindly randomised to continue 4 mg or taper to 2 mg. Patients could rescue (to 4 mg) if needed. Efficacy and safety were assessed through 48 weeks. RESULTS: Patients in both groups maintained LDA (80% 4 mg; 67% 2 mg) or REM (40% 4 mg; 33% 2 mg) over 48 weeks. However, dose reduction resulted in small, statistically significant increases in disease activity at 12, 24 and 48 weeks. Dose reduction also produced earlier and more frequent relapse (loss of step-down criteria) over 48 weeks compared with 4 mg maintenance (23% 4 mg vs 37% 2 mg, p=0.001). Rescue rates were 10% for baricitinib 4 mg and 18% for baricitinib 2 mg. Dose reduction was associated with a numerically lower rate of non-serious infections (30.6 for baricitinib 4 mg vs 24.9 for 2 mg). Rates of serious adverse events and adverse events leading to discontinuation were similar across groups. CONCLUSIONS: In a large randomised, blinded phase 3 study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4 mg was greater with continued 4 mg than after taper to 2 mg. Nonetheless, most patients tapered to 2 mg could maintain LDA/REM or recapture with return to 4 mg if needed. |
format | Online Article Text |
id | pubmed-6352419 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-63524192019-02-21 Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study Takeuchi, Tsutomu Genovese, Mark C Haraoui, Boulos Li, Zhanguo Xie, Li Klar, Rena Pinto-Correia, Ana Otawa, Susan Lopez-Romero, Pedro de la Torre, Inmaculada Macias, William Rooney, Terence P Smolen, Josef S Ann Rheum Dis Rheumatoid Arthritis OBJECTIVES: This study investigated the effects of dose step-down in patients with rheumatoid arthritis (RA) who achieved sustained disease control with baricitinib 4 mg once a day. METHODS: Patients who completed a baricitinib phase 3 study could enter a long-term extension (LTE). In the LTE, patients who received baricitinib 4 mg for ≥15 months and maintained CDAI low disease activity (LDA) or remission (REM) were blindly randomised to continue 4 mg or taper to 2 mg. Patients could rescue (to 4 mg) if needed. Efficacy and safety were assessed through 48 weeks. RESULTS: Patients in both groups maintained LDA (80% 4 mg; 67% 2 mg) or REM (40% 4 mg; 33% 2 mg) over 48 weeks. However, dose reduction resulted in small, statistically significant increases in disease activity at 12, 24 and 48 weeks. Dose reduction also produced earlier and more frequent relapse (loss of step-down criteria) over 48 weeks compared with 4 mg maintenance (23% 4 mg vs 37% 2 mg, p=0.001). Rescue rates were 10% for baricitinib 4 mg and 18% for baricitinib 2 mg. Dose reduction was associated with a numerically lower rate of non-serious infections (30.6 for baricitinib 4 mg vs 24.9 for 2 mg). Rates of serious adverse events and adverse events leading to discontinuation were similar across groups. CONCLUSIONS: In a large randomised, blinded phase 3 study, maintenance of RA control following induction of sustained LDA/REM with baricitinib 4 mg was greater with continued 4 mg than after taper to 2 mg. Nonetheless, most patients tapered to 2 mg could maintain LDA/REM or recapture with return to 4 mg if needed. BMJ Publishing Group 2019-02 2018-09-07 /pmc/articles/PMC6352419/ /pubmed/30194275 http://dx.doi.org/10.1136/annrheumdis-2018-213271 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (http://creativecommons.org/licenses/by-nc/4.0) |
spellingShingle | Rheumatoid Arthritis Takeuchi, Tsutomu Genovese, Mark C Haraoui, Boulos Li, Zhanguo Xie, Li Klar, Rena Pinto-Correia, Ana Otawa, Susan Lopez-Romero, Pedro de la Torre, Inmaculada Macias, William Rooney, Terence P Smolen, Josef S Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title | Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title_full | Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title_fullStr | Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title_full_unstemmed | Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title_short | Dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
title_sort | dose reduction of baricitinib in patients with rheumatoid arthritis achieving sustained disease control: results of a prospective study |
topic | Rheumatoid Arthritis |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6352419/ https://www.ncbi.nlm.nih.gov/pubmed/30194275 http://dx.doi.org/10.1136/annrheumdis-2018-213271 |
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