Article
Efficacy and safety of switching from adalimumab to baricitinib: phase 3 data in patients with rheumatoid arthritis
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Authors
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Peter Taylor
- Kennedy Institute of Rheumatology, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre,, Oxford, Großbritannien
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Edward Keystone
- The Rebecca MacDonald Centre For Arthritis, Mount Sinai Hospital, Toronto, Canada
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Robert Ortmann
- Eli Lilly and Company, Indianapolis, United States
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Maher Issa
- Eli Lilly and Company, Indianapolis, USA
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L Xie
- Eli Lilly & Company, Indianapolis, USA
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David Muram
- Eli Lilly and Company, Indianapolis, United States
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John Bradley
- Eli Lilly and Company, Indianapolis, USA
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Stephanie de Bono
- Eli Lilly and Company, Indianapolis, USA
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Terence Rooney
- Eli Lilly and Company, Indianapolis, USA
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Yoshiya Tanaka
- School of Medicine, University of Occupational & Environmental Health, Kitakyushu, Japan
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Steffen Eppendorfer
- Lilly Deutschland GmbH, Bad Homburg
| Published: | September 4, 2017 |
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Outline
Text
Background: Baricitinib (bari) is an oral JAK1/JAK2 inhibitor for the treatment of patients (pts) with moderate to severe rheumatoid arthritis (RA). The objective of this analysis was to evaluate efficacy and safety in pts from RA-BEAM who switched from adalimumab (ADA) to bari either after rescue in RA-BEAM or after entering a long-term extension (LTE) study (RA-BEYOND).
Methods: In RA-BEAM, 1305 pts were randomized 3:3:2 to placebo (PBO), bari 4 mg once daily, or ADA 40 mg every 2 weeks (wks). From Wk 16, inadequate responders were rescued to open-label bari 4 mg. At Wk 52, pts could enter the LTE, where all (non-rescued) pts received bari 4 mg and remained blinded to their randomized treatment in RA-BEAM. No ADA washout period was applied for rescue or switch from ADA to bari. Efficacy analyses evaluated both rescued and non-rescued RA-BEAM pts who entered the LTE ≥24 wks before the data cutoff. Safety analyses included pts not rescued in RA-BEAM who entered the LTE.
Results: A total of 51 pts were rescued from ADA to bari 4 mg in RA-BEAM; at Wk 52, 67%, 49% and 24% achieved ACR20, ACR50 and ACR70, respectively. Among pts who completed RA-BEAM without rescue, 381/394 (97%) bari and 238/241 (99%) ADA pts entered the LTE. Of these, 185 (continued bari) and 108 ADA (switched to bari) pts reached the 24 wk timepoint and were included in the LTE efficacy analysis; 340 (continued bari) and 211 ADA (switched to bari) pts were included in the LTE safety analysis. Patients who switched from ADA to bari showed improvements in disease control through 12 wks post-switch in the LTE, without evidence of worsening through the following 12 wks. Exposure-adjusted incidence rates for total treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for pts who switched from ADA to bari and those who continued on bari.
Conclusion: Switching from ADA to bari without ADA washout was associated with improvements in disease control during the initial 12 wks post-switch, without an increase in overall TEAEs, serious adverse events or infections, and without subsequent evidence of worsening.
