Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment

Abstract

In this integrated analysis of patients with moderate to severe active RA with exposure up to 5.5 years, baricitinib has an acceptable safety profile in the context of demonstrated efficacy. Trial registration numbers: NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and NCT01885078 at clinicaltrials.gov.

COVID-19 infection and rheumatoid arthritis: Faraway, so close!

“…Data from tofacitinib pooled population enrolled in RCTs showed an HZV incidence rate of 4.0 per 100 patient-years (with greater incidence in geographic area with high HZV endemicity), doubling the rates of RA patients not receiving JAKis [67]. A similar picture has J o u r n a l P r e -p r o o f Journal Pre-proof also been observed in the overall development program of baricitinib, with an incidence rate of 3.2 cases per patient-years [68]. The subsequent real-life experience from US claim databases revealed that the risk of HZV was higher in patients receiving tofacitinib compared to those treated with abatacept (aHR 2.01 (95% CI 1.40; 2.88) [69], and the risk of serious hospitalized HZV infection is 2-fold higher versus all bDMARDs [70].…”

Safety of baricitinib in East Asian patients with moderate‐to‐severe active rheumatoid arthritis: An integrated analysis from clinical trials

“…The safety profile of baricitinib from the global clinical development program in RA (data up to 5.5 years) has been recently reported . Here, we report the first integrated safety profile of baricitinib in EA patients, with moderate‐to‐severely active RA for 1294 PY of exposure (median 1.9 years, maximum 3.5 years).…”

“…Gastrointestinal (GI) perforation is a known risk in patients with RA, especially in patients receiving nonsteroidal anti‐inflammatory drugs (NSAIDs) and/or steroids . The IR of GI perforation in the overall population in baricitinib clinical studies from published data is 0.05/100 PY . Two cases of GI perforation were reported in All Bari RA EA (EAIR: 0.1 each): a perforated diverticulum and a perforated appendix.…”

“…Baricitinib is an oral, once daily, reversible, selective JAK1/JAK2 inhibitor, approved for the treatment of moderate‐to‐severely active RA in adults. Baricitinib has demonstrated clinical efficacy in several Phase 2 and Phase 3 studies, with an acceptable safety profile that is similar to other approved RA therapies . In addition, baricitinib has shown superior efficacy to 2 standard‐of‐care RA treatments (MTX and adalimumab) for certain pre‐specified endpoints .…”

Janus kinase inhibitors for the treatment of rheumatoid arthritis demonstrate similar profiles of in vitro cytokine receptor inhibition

“…4,5,9 Cytokine receptor inhibitory concentration (IC xx ) profiles were generally similar among the JAK inhibitors, with small numerical differences in percentage cytokine receptor inhibition, suggesting limited differentiation of these JAK inhibitors based on in vitro phar- respectively, vs 1.0 with placebo. 33 HZ has also been reported in phase 3 RA studies of upadacitinib and filgotinib. 17,18 As such, the occurrence of HZ is likely a "class effect" of inhibiting at least JAK1, 34 although viral reactivation could also be dependent on the overall impact of JAK inhibition.…”