Cytokine Signalling Forum

Publications





May 20

Evaluación del Virus Hepatitis B en Ensayos Clínicos de Baricitinib en Artritis Reumatoide

Harigai M, Winthrop K, Takeuchi T, Hsieh T-Y, Chen Y-M, Smolen JS, Burmester G, Walls C, Wu W-S, Dickson C, Liao R, Genovese MC.
RMD Open 2020;6:e001095

Although hepatitis B virus (HBV) reactivation was seen in patients with RA treated with DMARDs, including BARI, who had serology suggestive of prior infection, reactivation was transient even with continued BARI treatment and did not account for any clinically relevant AEs. Reactivation of HBV replication is a recognised complication in patients receiving biologic agents for RA, such as DMARDs. Limited data exist on prevalence of occult infection and the incidence of reactivation in RA patients...

Keywords: JAK, Baricitinib, Clinical, Safety

Translated by: Igor Koz

March 19

Perfil de Seguridad de Baricitinib en Pacientes Japoneses con Artritis Reumatoide Activa con más de 1.6 años de Tiempo Medio de Tratamiento: Un análisis integrado de Estudios Fase 2 y 3

Harigai M, Takeuchi T, Smolen JS, Winthrop KL, Nishikawa A, Rooney TP, Saifan CG, Issa M, Isaka Y, Akashi N, Ishii T, Tanaka Y.
Mod Rheumatol. 2019 Feb 20:1-23. DOI: 10.1080/14397595.2019.1583711

In this integrated analysis, BARI showed an acceptable safety profile in Japanese patients with up to 3.2 years of exposure. Other than incidences of herpes zoster (HZ), no major differences were noted with BARI safety in Japanese patients with RA, compared to the patients in the integrated database. BARI has previously demonstrated significant clinical efficacy and acceptable safety. Japanese patients who participated in the BARI clinical development programme, were comparable to those from th...

Keywords: JAK, Baricitinib, Clinical, Safety

Translated by: Igor