10.6084/m9.figshare.7874225.v2
Masayoshi Harigai
Masayoshi
Harigai
Tsutomu Takeuchi
Tsutomu
Takeuchi
Josef S. Smolen
Josef S.
Smolen
Kevin L. Winthrop
Kevin L.
Winthrop
Atsushi Nishikawa
Atsushi
Nishikawa
Terence P. Rooney
Terence P.
Rooney
Chadi G. Saifan
Chadi G.
Saifan
Maher Issa
Maher
Issa
Yoshitaka Isaka
Yoshitaka
Isaka
Naotsugu Akashi
Naotsugu
Akashi
Taeko Ishii
Taeko
Ishii
Yoshiya Tanaka
Yoshiya
Tanaka
Safety profile of baricitinib in Japanese patients with active rheumatoid arthritis with over 1.6 years median time in treatment: An integrated analysis of Phases 2 and 3 trials
Taylor & Francis Group
2020
Baricitinib
Janus kinase (JAK)
Japanese
safety
rheumatoid arthritis
2020-01-07 06:32:15
Journal contribution
https://tandf.figshare.com/articles/journal_contribution/Safety_profile_of_baricitinib_in_Japanese_patients_with_active_rheumatoid_arthritis_with_over_1_6_years_median_time_in_treatment_An_integrated_analysis_of_Phases_2_and_3_trials/7874225
<p><b>Objectives:</b> Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib’s safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies).</p> <p><b>Methods:</b> Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RA patients exposed to any baricitinib dose.</p> <p><b>Results:</b> Five hundred and fourteen Japanese patients received baricitinib for 851.5 total PY of exposure (median 1.7 years, maximum 3.2). The EAIR of treatment-emergent AEs was 57.4/100PY. There were no deaths; 31 patients had serious infections (IR: 3.6/100PY), 55 herpes zoster (6.5), 0 tuberculosis, 10 malignancies (1.1) including two lymphomas, two major cardiovascular AEs (0.3), one gastrointestinal perforation (0.1), and four deep vein thrombosis (0.5). In Japanese patients, herpes zoster was more frequent than that of patients overall in the integrated database, but the events were considered manageable.</p> <p><b>Conclusion:</b> In this analysis, baricitinib had acceptable safety profile in Japanese RA patients in the context of demonstrated efficacy. Aside from herpes zoster, baricitinib safety was not notably different between Japanese RA patients and those RA patients in the integrated database.</p> <p><b>Trial registration:</b> NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and NCT01885078 at <a href="https://clinicaltrials.gov/" target="_blank">https://clinicaltrials.gov/</a></p>