Artikel
Baricitinib inhibits radiographic progression of structural joint damage at 1 year in patients with rheumatoid arthritis (RA) and an inadequate response to csDMARDs
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Autoren
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Desiree van der Heijde
- Leiden University Medical Center, Department of Rheumatology, Leiden, The Netherlands
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Maxime Dougados
- Hôpital Cochin, Department of Rheumatology, Paris, France
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Y.C Chen
- Chang Gung Memorial Hospital, Kaohsiung, Taiwan
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Maria Greenwald
- Desert Medical Advances, Palm Desert, USA
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E Drescher
- Veszprém Csolnoky Ferenc County Hospital, Vészprem, Hungary
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Rena Klar
- Quintiles Transnational INC, Durham, USA
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L Xie
- Eli Lilly & Company, Indianapolis, USA
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Inmaculada de la Torre
- Eli Lilly Spain, Alcobendas, Spain
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Terence Rooney
- Eli Lilly and Company, Indianapolis, USA
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Sarah Witt
- Eli Lilly & Company,, Indianapolis
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Douglas Schlichting
- Eli Lilly and Company, Indianapolis, USA
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Stephanie de Bono
- Eli Lilly and Company, Indianapolis, USA
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Paul Emery
- University of Leeds, Leeds, United Kingdom
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Kirsten Röhl
- Lilly Deutschland GmbH, Bad Homburg
| Veröffentlicht: | 4. September 2017 |
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Gliederung
Text
Background: Baricitinib (bari), a JAK1/2 inhibitor, was efficacious in a 24-week (wk) Ph 3 study in patients (pts) with active RA and an inadequate response (IR) to conventional synthetic DMARDs (csDMARDs) (RA-BUILD). The objective of this analysis was to evaluate radiographic progression of structural joint damage in RA-BUILD pts with an IR or intolerance to ≥1 csDMARD over 48 wks of bari treatment in the long-term extension study, RA-BEYOND.
Methods: In the 24-wk RA-BUILD study, pts were randomized to placebo (PBO) (N=228), bari 2mg (N=229) or bari 4 mg (N=227) once daily, with rescue possible from Wk 16. Pts completing RA-BUILD and entering RA-BEYOND continued on the bari dose received at the end of RA-BUILD. Pts receiving PBO at the end of RA-BUILD were switched to bari 4 mg in RA-BEYOND. Pt and investigator blinding was maintained in RA-BEYOND. Joint damage was measured using the van der Heijde modified total Sharp score (mTSS). To account for missing scores and scores obtained after rescue or discontinuation of the study drug, data were analysed using 1) linear extrapolation (LE), and 2) last observation carried forward (LOCF). The observed/LOCF method used all available observed data, including after rescue or switch, with pts analysed according to original treatment assignment.
Results: Using LE, progression of mTSS, bone erosion, and joint space narrowing at 24 and 48 wks was statistically significantly lower for both bari 2 or 4 mg compared to PBO (p≤0.05). Only bari 4 mg demonstrated a statistically significant inhibition of progressive radiographic joint damage compared to PBO using observed/LOCF at Wk 48 or based on categorical measures (p≤0.05).
Conclusion: Once daily oral bari inhibited radiographic progression of structural joint damage in pts with an IR or intolerance to csDMARDs over 48 wks of treatment. The most robust benefit across measures of radiographic progression was seen for the 4 mg dose.
