Baricitinib versus placebo or adalimumab in rheumatoid arthritis
<h4>Background</h4> <p>Baricitinib is an oral, reversible, JAK1/JAK2 inhibitor that may have therapeutic value in patients with rheumatoid arthritis.</p> <h4>Methods</h4> <p>In this 52-week, phase 3, double-blind, placebo and active-controlled study, 1307 p...
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| Materiálatiipa: | Journal article |
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Massachusetts Medical Society
2017
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| _version_ | 1826280300234145792 |
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| author | Taylor, P Keystone, E Van der Heijde, D Weinblatt, M del Carmen Morales, L Reyes Gonzaga, J Yakushin, S Ishii, T Emoto, K Beattie, S Arora, V Gaich, C Rooney, T Schlichting, D Macias, W de Bono, S Tanaka, Y |
| author_facet | Taylor, P Keystone, E Van der Heijde, D Weinblatt, M del Carmen Morales, L Reyes Gonzaga, J Yakushin, S Ishii, T Emoto, K Beattie, S Arora, V Gaich, C Rooney, T Schlichting, D Macias, W de Bono, S Tanaka, Y |
| author_sort | Taylor, P |
| collection | OXFORD |
| description | <h4>Background</h4> <p>Baricitinib is an oral, reversible, JAK1/JAK2 inhibitor that may have therapeutic value in patients with rheumatoid arthritis.</p> <h4>Methods</h4> <p>In this 52-week, phase 3, double-blind, placebo and active-controlled study, 1307 patients with active rheumatoid arthritis receiving background methotrexate were randomized 3:3:2 to placebo (switched to baricitinib after 24 weeks), baricitinib 4-mg once daily, or anti-tumor necrosis factor α monoclonal antibody, adalimumab, 40-mg every other week. Endpoint measures controlled for multiplicity included American College of Rheumatology 20% response (ACR20, primary endpoint), 28-joint Disease Activity Scores (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Simplified Disease Activity Index (SDAI) at Week 12, and progressive radiographic joint damage as measured by van der Heijde modified Total Sharp score (mTSS) at Week 24.</p> <h4>Results</h4> <p>More patients achieved an ACR20 response at Week 12 with baricitinib than placebo (primary objective, 70% vs. 40%, P≤0.001). All major secondary objectives were met, including inhibition of progressive radiographic joint damage (mTSS, range 0 to 448, with higher scores indicating greater damage) at Week 24 for baricitinib vs. placebo (mean change from baseline 0.41 vs.0.90, P≤0.001) and increased ACR20 response rate at Week 12 for baricitinib vs. adalimumab (70% vs. 61%, P=0.014). Adverse events, including infections, were more frequent through Week 24 for baricitinib and adalimumab compared to placebo. Malignancies were reported in 5 patients (2 baricitinib, 3 placebo). Baricitinib was associated with reductions in neutrophils and increases in creatinine and low-density lipoprotein cholesterol.</p> <h4>Conclusions</h4> <p> In patients with rheumatoid arthritis with inadequate response to methotrexate, baricitinib was associated with significant clinical improvements compared to placebo and adalimumab </p> |
| first_indexed | 2024-03-07T00:11:37Z |
| format | Journal article |
| id | oxford-uuid:796f29d8-af30-4868-9a7c-863c68c78ff3 |
| institution | University of Oxford |
| last_indexed | 2024-03-07T00:11:37Z |
| publishDate | 2017 |
| publisher | Massachusetts Medical Society |
| record_format | dspace |
| spelling | oxford-uuid:796f29d8-af30-4868-9a7c-863c68c78ff32022-03-26T20:37:27ZBaricitinib versus placebo or adalimumab in rheumatoid arthritisJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:796f29d8-af30-4868-9a7c-863c68c78ff3Symplectic Elements at OxfordMassachusetts Medical Society2017Taylor, PKeystone, EVan der Heijde, DWeinblatt, Mdel Carmen Morales, LReyes Gonzaga, JYakushin, SIshii, TEmoto, KBeattie, SArora, VGaich, CRooney, TSchlichting, DMacias, Wde Bono, STanaka, Y <h4>Background</h4> <p>Baricitinib is an oral, reversible, JAK1/JAK2 inhibitor that may have therapeutic value in patients with rheumatoid arthritis.</p> <h4>Methods</h4> <p>In this 52-week, phase 3, double-blind, placebo and active-controlled study, 1307 patients with active rheumatoid arthritis receiving background methotrexate were randomized 3:3:2 to placebo (switched to baricitinib after 24 weeks), baricitinib 4-mg once daily, or anti-tumor necrosis factor α monoclonal antibody, adalimumab, 40-mg every other week. Endpoint measures controlled for multiplicity included American College of Rheumatology 20% response (ACR20, primary endpoint), 28-joint Disease Activity Scores (DAS28), Health Assessment Questionnaire-Disability Index (HAQ-DI), and Simplified Disease Activity Index (SDAI) at Week 12, and progressive radiographic joint damage as measured by van der Heijde modified Total Sharp score (mTSS) at Week 24.</p> <h4>Results</h4> <p>More patients achieved an ACR20 response at Week 12 with baricitinib than placebo (primary objective, 70% vs. 40%, P≤0.001). All major secondary objectives were met, including inhibition of progressive radiographic joint damage (mTSS, range 0 to 448, with higher scores indicating greater damage) at Week 24 for baricitinib vs. placebo (mean change from baseline 0.41 vs.0.90, P≤0.001) and increased ACR20 response rate at Week 12 for baricitinib vs. adalimumab (70% vs. 61%, P=0.014). Adverse events, including infections, were more frequent through Week 24 for baricitinib and adalimumab compared to placebo. Malignancies were reported in 5 patients (2 baricitinib, 3 placebo). Baricitinib was associated with reductions in neutrophils and increases in creatinine and low-density lipoprotein cholesterol.</p> <h4>Conclusions</h4> <p> In patients with rheumatoid arthritis with inadequate response to methotrexate, baricitinib was associated with significant clinical improvements compared to placebo and adalimumab </p> |
| spellingShingle | Taylor, P Keystone, E Van der Heijde, D Weinblatt, M del Carmen Morales, L Reyes Gonzaga, J Yakushin, S Ishii, T Emoto, K Beattie, S Arora, V Gaich, C Rooney, T Schlichting, D Macias, W de Bono, S Tanaka, Y Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title | Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title_full | Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title_fullStr | Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title_full_unstemmed | Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title_short | Baricitinib versus placebo or adalimumab in rheumatoid arthritis |
| title_sort | baricitinib versus placebo or adalimumab in rheumatoid arthritis |
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