Bradley, J

De Bono, S

Faraawi, R

Issa, M

Keystone, E

Muram, D

Ortmann, R

Rooney, T

Tanaka, Y

Taylor, P

Xie, L

Taylor, Peter

Oxford University Research Archive

Efficacy and Safety of Switching from Adalimumab to Baricitinib: Phase 3 Data in Patients with Rheumatoid Arthritis  Peter Taylor (University of Oxford, Oxford); Edward Keystone (Mount Sinai Hospital, University of Toronto, Toronto); Robert Ortmann (Eli Lilly and Company, Indianapolis); Maher Issa (Eli Lilly and Company, Indianapolis); Li Xie (Eli Lilly and Company, Indianapolis); David Muram (Eli Lilly and Company, Indianapolis); John Bradley (Eli Lilly and Company, Indianapolis); Stephanie de Bono (Eli Lilly and Company, Indianapolis); Terence Rooney (Eli Lilly and Company, Indianapolis); Yoshiya Tanaka (University of Occupational and Environmental Health, Kitakyushu); Rafat Faraawi (McMaster University, Kitchener-Waterloo)  Objectives: Baricitinib is an oral JAK1/JAK2 inhibitor under investigation for the treatment of patients with moderate to severe RA.1,2 In the 52-week Phase 3 RA-BEAM study, baricitinib 4 mg once daily (QD) showed clinical improvements compared to placebo and to adalimumab in MTX-inadequateresponder (IR) patients.2 The objective of this analysis was to evaluate efficacy and safety in patients from RA-BEAM who changed treatment from adalimumab to baricitinib either after rescue in RA-BEAM or switch after entering a long-term extension study (RA-BEYOND).  Methods: In RA-BEAM (completed September 2015), 1305 patients were randomized 3:3:2 to placebo, baricitinib 4 mg QD, or adalimumab 40 mg every 2 weeks. At Week 16 or subsequent visits, IRs (lack of ≥ 20% reduction in tender and swollen joint count) were rescued to open-label baricitinib 4 mg. At Week 52, patients could enter RA-BEYOND, where all patients received baricitinib 4 mg and remained blinded to their randomized treatment in RA-BEAM. No adalimumab washout period was applied for rescue or switch from adalimumab to baricitinib. Efficacy analyses evaluated both rescued and not rescued RA-BEAM patients who entered RABEYOND ≥ 24 weeks before the present data cutoff. Safety analyses included patients not rescued in RA-BEAM who entered RA-BEYOND.  Results: A total of 51 patients were rescued from adalimumab to Baricitinib ACR50, and ACR70, respectively. Among patients who completed RABEAM without rescue, 381/394 (97%) baricitinib, and 238/241 (99%) adalimumab patients entered RA-BEYOND. Of these, 185 (continued baricitinib) and 108 adalimumab (switched to baricitinib) patients reached the 24-week time point and were included in the RA-BEYOND efficacy analysis; 340 (continued baricitinib) and 211 adalimumab (switched to baricitinib) patients were included in the RA-BEYOND safety analysis. Patients who switched from adalimumab to baricitinib showed improvements in disease control through 12 weeks post-switch in RA-BEYOND, without evidence of worsening through the following 12 weeks. Exposure-adjusted incidence rates for total treatment-emergent adverse events (TEAEs) and infections, including serious events, were similar for patients who switched from adalimumab to baricitinib and those who continued on baricitinib.  Conclusion: Switching from adalimumab to baricitinib without adalimumab washout was associated with improvements in disease control during the initial 12 weeks post-switch, without an increase in overall TEAEs, serious adverse events or infections, and without subsequent evidence of worsening.  References: 1Dougados M et al. Ann Rheum Dis 2015;74(S2):79. 2Taylor PC et al. Arthritis Rheumatol 2015;67(S10):3927-3928. 

English

Efficacy and safety of switching from adalimumab to baricitinib: phase 3 data in patients with rheumatoid arthritis

Efficacy and safety of switching from adalimumab to baricitinib: phase 3 data in patients with rheumatoid arthritis

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