Baricitinib as monotherapy for treatment of rheumatoid arthritis: analysis of real-world data
Creators: name: Edwards, Christoper J.
name: Takeuchi, Tsutomu
name: Finckh, Axel
name: Kleyer, Arnd
name: Haladyj, Ewa
name: Gerwien, Jens Gammeltoft
name: Treuer, Tamás
name: Zaremba-Pechmann, Liliana
name: Smolen, Josef S.
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Medicine
subject: Physiology
subject: FOS: Biological sciences
subject: Pharmacology
subject: Biotechnology
subject: Ecology
subject: Immunology
subject: FOS: Clinical medicine

description: Baricitinib is an oral, reversible and selective inhibitor of Janus kinase (JAK)1 and JAK2 that is approved as monotherapy or in combination with methotrexate for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) who have responded inadequately to disease-modifying antirheumatic drugs. Evidence supporting the approved monotherapy indication is growing in real-world settings that reflect routine clinical practice. Results of separate analyses of real-world data from the observational prospective RA-BE-REAL, Erlangen Baricitinib cohort, the BSRBR-RA, and Swiss Clinical Quality Management in Rheumatic Diseases (SCQM) registries, and the retrospective ORBIT-RA and SUSTAIN long-term chart reviews were reported, documenting baseline data and outcomes for a total of 932 patients with active RA receiving baricitinib as monotherapy. Findings were contrasted with those from a total of 850 patients receiving the drug as combination therapy. All analyses were descriptive and completed in September 2022. Across the patient registries and observational studies, 39.4%–69.6% of patients received baricitinib monotherapy for the treatment of active RA. In these patients, after about 6–12 months of treatment, 40.7%–93.8% and 55.6%–88.0% achieved remission or low disease activity according to the composite measures of disease activity 28-joint count and Clinical Disease Activity Index, respectively. Treatment continuation/discontinuation rates differed across the studies. These findings suggest that baricitinib monotherapy can be a suitable treatment option in routine clinical practice for patients with RA, when used in accordance with current guidelines. Baricitinib is an oral treatment for moderate-to-severe active rheumatoid arthritis. It is used, by itself as monotherapy or combined with another drug called methotrexate, to treat adults who have not responded well to first-line drugs. The use of baricitinib as monotherapy has not been well studied in clinical trials. However, an increasing amount of information supporting the approved monotherapy indication is available from patients treated in routine clinical practice since its first approval in 2017. This differs from information obtained from clinical trials in that it is from a more diverse group of people with rheumatoid arthritis and reflects the use of baricitinib in the real world. The current article looks at the outcomes of patients treated with baricitinib across many countries obtained from six different sources of information from patients in clinical practice. Across the different sources, 39.4%–69.6% of patients with active rheumatoid arthritis were treated with baricitinib as monotherapy. In these patients, changes in combined measures that considered different aspects of rheumatoid arthritis supported the use of baricitinib. Assessments were made after 6–12 months of treatment. The proportions of patients stopping or continuing baricitinib can indicate how well baricitinib is working and how well it is tolerated. These proportions differed across the studies so we were unable to draw any conclusions for this measure. Overall, the information we provide suggests that baricitinib as monotherapy is a suitable treatment option in routine clinical practice for many patients with rheumatoid arthritis, when used according to current guidelines.