A JAK Inhibitor for Treatment of Rheumatoid Arthritis: The Baricitinib Experience

Author:

Taylor Peter C.1ORCID,Laedermann Cedric2,Alten Rieke3,Feist Eugen4,Choy Ernest5,Haladyj Ewa2,De La Torre Inmaculada2,Richette Pascal67,Finckh Axel8ORCID,Tanaka Yoshiya9ORCID

Affiliation:

1. Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford OX3 7LD, UK

2. Eli Lilly and Company, Indianapolis, IN 46285, USA

3. Internal Medicine II, Rheumatology, SCHLOSSPARK-KLINIK, University Medicine Berlin, 14059 Berlin, Germany

4. Department of Rheumatology, Helios Clinic Vogelsang-Gommern, Cooperation Partner of the Otto-von-Guericke University Magdeburg, 39245 Magdeburg, Germany

5. Division of Infection and Immunity, Cardiff University School of Medicine, Cardiff CF14 4YS, UK

6. Service de Rhumatologie, Hôpital Lariboisière, 75010 Paris, France

7. Inserm, UMR-S 1132, Bioscar, Université de Paris, 75010 Paris, France

8. Division of Rheumatology, Department of Medicine, Geneva University Hospitals, 1205 Geneva, Switzerland

9. First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu 807-0804, Japan

Abstract

Baricitinib, an oral selective Janus kinase (JAK)1/JAK2 inhibitor, is approved as monotherapy or in combination with methotrexate for treating adults with moderate-to-severe active rheumatoid arthritis (RA) and provides improvements in clinical signs, symptoms and patient-reported outcomes. Currently, baricitinib is approved for treating RA in more than 75 countries. In several pivotal Phase II and III RA trials (RA-BALANCE, RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON, RA-BEYOND), up to seven years of baricitinib treatment was well tolerated and provided rapid and sustained efficacy, which was confirmed in real-world settings. Safety signals for another JAK inhibitor, tofacitinib, have emerged, as observed in the post-marketing Phase IIIb/IV trial Oral Rheumatoid Arthritis Trial (ORAL) Surveillance; safety signals were subsequently highlighted in a retrospective study of baricitinib and consequently new recommendations and warnings and precautions for all JAK inhibitors have been issued. Ongoing studies to further characterise and clarify the benefit:risk of JAK inhibitors include registries and controlled trials. This capstone review summarises clinical and real-world data outlining the benefit:risk profile of baricitinib, confirming that the improved disease activity and physical function of patients with RA treated with this JAK inhibitor observed in clinical trials is translated into effectiveness in clinical practice, with a low rate of discontinuations.

Funder

Eli Lilly and Company

Publisher

MDPI AG

Subject

General Medicine

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