Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN)
<p><strong>Objective:</strong> To determine whether early changes in disease activity predict later achievement of low disease activity (LDA) or remission in patients treated with baricitinib 4 mg in global phase 3 studies.</p> <p><strong>Methods:</strong>...
| Main Authors: | , , , , , , , , |
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| Format: | Journal article |
| Language: | Japanese |
| Published: |
Iyaku-Joho-Kenkyujo, Inc.
2021
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| _version_ | 1826308047022063616 |
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| author | Tanaka, Y Weinblatt, M Taylor, PC Fleischmann, R Ishizuka, T Tanaka, M Takita, Y Schlichting, D Takeuchi, T |
| author_facet | Tanaka, Y Weinblatt, M Taylor, PC Fleischmann, R Ishizuka, T Tanaka, M Takita, Y Schlichting, D Takeuchi, T |
| author_sort | Tanaka, Y |
| collection | OXFORD |
| description | <p><strong>Objective:</strong> To determine whether early changes in disease activity predict later achievement of low disease activity (LDA) or remission in patients treated with baricitinib 4 mg in global phase 3 studies.</p>
<p><strong>Methods:</strong> This analysis examined 487 patients and 159 patients randomized to baricitinib 4 mg in RA-BEAM and RA-BEGIN, respectively. Early response was predefined as Clinical Disease Activity Index (CDAI) improvement from baseline to Week 4 of ≥6.0. LDA and remission were based on Simplified Disease Activity Index at Weeks 12 and 24.</p>
<p><strong>Results:</strong> At Week 4, the majority of baricitinib-treated patients had CDAI improvement ≥ 6.0 in RA-BEAM (86%) and RA-BEGIN (85%), with high LDA/remission rates at Weeks 12 and 24. Negative predictive values (NPVs) based on CDAI improvement < 6 from baseline to Week 4 exceeded 90% for remission at Week 24. In comparison, NPVs for LDA at Week 24 were lower (RA-BEAM, 80%; RA-BEGIN, 58%).</p>
<p><strong>Conclusion:</strong> CDAI improvement ≥ 6.0 at Week 4 was associated with improved clinical outcomes at Weeks 12 and 24 whereas patients who were early non-responders were unlikely to achieve remission at these time points.</p> |
| first_indexed | 2024-03-07T07:13:45Z |
| format | Journal article |
| id | oxford-uuid:580d30b5-2e50-4bc5-aa95-b87c23dfc7fd |
| institution | University of Oxford |
| language | Japanese |
| last_indexed | 2024-03-07T07:13:45Z |
| publishDate | 2021 |
| publisher | Iyaku-Joho-Kenkyujo, Inc. |
| record_format | dspace |
| spelling | oxford-uuid:580d30b5-2e50-4bc5-aa95-b87c23dfc7fd2022-07-15T09:27:20ZLack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN)Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:580d30b5-2e50-4bc5-aa95-b87c23dfc7fdJapaneseSymplectic ElementsIyaku-Joho-Kenkyujo, Inc.2021Tanaka, YWeinblatt, MTaylor, PCFleischmann, RIshizuka, TTanaka, MTakita, YSchlichting, DTakeuchi, T<p><strong>Objective:</strong> To determine whether early changes in disease activity predict later achievement of low disease activity (LDA) or remission in patients treated with baricitinib 4 mg in global phase 3 studies.</p> <p><strong>Methods:</strong> This analysis examined 487 patients and 159 patients randomized to baricitinib 4 mg in RA-BEAM and RA-BEGIN, respectively. Early response was predefined as Clinical Disease Activity Index (CDAI) improvement from baseline to Week 4 of ≥6.0. LDA and remission were based on Simplified Disease Activity Index at Weeks 12 and 24.</p> <p><strong>Results:</strong> At Week 4, the majority of baricitinib-treated patients had CDAI improvement ≥ 6.0 in RA-BEAM (86%) and RA-BEGIN (85%), with high LDA/remission rates at Weeks 12 and 24. Negative predictive values (NPVs) based on CDAI improvement < 6 from baseline to Week 4 exceeded 90% for remission at Week 24. In comparison, NPVs for LDA at Week 24 were lower (RA-BEAM, 80%; RA-BEGIN, 58%).</p> <p><strong>Conclusion:</strong> CDAI improvement ≥ 6.0 at Week 4 was associated with improved clinical outcomes at Weeks 12 and 24 whereas patients who were early non-responders were unlikely to achieve remission at these time points.</p> |
| spellingShingle | Tanaka, Y Weinblatt, M Taylor, PC Fleischmann, R Ishizuka, T Tanaka, M Takita, Y Schlichting, D Takeuchi, T Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title | Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title_full | Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title_fullStr | Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title_full_unstemmed | Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title_short | Lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis: results from two phase 3 studies (RA-BEAM and RA-BEGIN) |
| title_sort | lack of clinical disease activity response at 4 weeks of baricitinib treatment as a negative predictor of remission at weeks 12 and 24 in patients with rheumatoid arthritis results from two phase 3 studies ra beam and ra begin |
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