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Efficacy of baricitinib in patients with moderate-to-severe rheumatoid arthritis with 3 years of treatment: results from a long-term study

Author

Rheumatology (Oxford). 2020 Nov 17;keaa576. doi: 10.1093/rheumatology/keaa576.Online ahead of print.

Josef S Smolen 1Li Xie 2Bochao Jia 2Peter C Taylor 3Gerd Burmester 4Yoshiya Tanaka 5Ayesha Elias 2Anabela Cardoso 2Rob Ortmann 2Chad Walls 2Maxime Dougados 6

Author Information

1 Division of Rheumatology, Department of Medicine III, Medical University of Vienna, Vienna, Austria.

2 Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.

3 Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

4 Charité - University of Medicine Berlin, Berlin, Germany.

5 The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.

6 Cochin Hospital, Paris, France.

Abstract

Objective: To evaluate the long-term efficacy of once-daily baricitinib 4 mg in patients with active RA who were either naïve to DMARDs or who had inadequate response (IR) to MTX.

Methods: Analyses of data from two completed 52-week, phase III studies, RA-BEGIN (DMARD-naïve) and RA-BEAM (MTX-IR), and one ongoing long-term extension (LTE) study (RA-BEYOND) were performed (148 total weeks). At week 52, DMARD-naïve patients treated with MTX monotherapy or baricitinib 4 mg+MTX in RA-BEGIN were switched to open-label baricitinib 4 mg monotherapy; MTX-IR patients treated with adalimumab (+MTX) in RA-BEAM were switched to open-label baricitinib 4 mg (+MTX) in the LTE. Patients who received placebo (+MTX) were switched to baricitinib 4 mg (+MTX) at week 24. Low disease activity (LDA) [Simple Disease Activity Index (SDAI) ≤11], clinical remission (SDAI ≤ 3.3), and physical functioning [Health Assessment Questionnaire Disability Index (HAQ-DI) ≤ 0.5] were assessed. Data were assessed using a non-responder imputation.

Results: At week 148, SDAI LDA was achieved in up to 61% of DMARD-naïve patients and 59% of MTX-IR patients initially treated with baricitinib, and SDAI remission was achieved in up to 34% of DMARD-naïve patients and 24% of MTX-IR patients; HAQ-DI ≤ 0.5 was reached in up to 48% of DMARD-naïve patients and 38% of MTX-IR patients initially treated with baricitinib. Over 148 weeks, 3.6% and 10.7% of MTX-IR patients discontinued across treatment groups due to lack of efficacy or due to adverse events, respectively; discontinuation rates were similar in the DMARD-naïve population.

Conclusion: Treatment with baricitinib 4 mg demonstrated efficacy for up to 3 years and was well tolerated.