SAT0218 Efficacy and safety of baricitinib in mtx-ir patients with rheumatoid arthritis: 52 week results from a phase 3 study (RA-BALANCE)

Abstract

Background:Baricitinib (BARI) is an oral selective inhibitor of Janus kinase 1 (JAK1) and JAK2. In the EU and some other countries, baricitinib has been approved for the treatment of moderately to severely active rheumatoid arthritis (RA) in adult patients. This abstract reports efficacy and safety results from a phase 3, double-blinded, 52-week study (RA-BALANCE) that enrolled patients (pts) in China, Argentina and Brazil (NCT02265705).Objectives:To assess the efficacy and safety of BARI vs placebo (PBO) in the treatment of RA.Methods:Patients with moderately to severely active RA (tender joint counts ≥6 & swollen joint counts ≥6 & hsCRP≥6 mg/L) despite stable background methotrexate (MTX), were randomized 1:1 to PBO (n=145) or BARI 4-mg (n=145) once daily (QD), stratified by country and baseline joint erosion status. Background MTX was continued. Non-responders were rescued from Week 16. At Week 24, pts receiving PBO were switched to BARI 4-mg QD. ACR20 at Week 12 was the primary endpoint and there were multiple secondary endpoints e.g., assessing physical function, low disease activity and pain.Results:The primary ACR20 response was significantly greater for BARI than PBO (58.6% vs 28.3%, p≤0.001, Table). At Weeks 12 and 24, significant improvements were seen in pts receiving BARI vs PBO for ACR20/50/70, DAS28-hsCRP, CDAI low disease activity and SDAI low disease activity, many as early as by Week 1. At Week 16, significantly less radiographic progression was seen in pts receiving BARI vs PBO and numerical improvement was observed at Week 24. At Week 12, significant improvement in HAQ-DI minimum clinically important difference ≥0.3 (physical function), duration of morning joint stiffness, severity of morning joint stiffness numeric rating scale (NRS), worst tiredness NRS and reduced pain (0–100 mm VAS) were seen in pts receiving BARI vs PBO.During Weeks 0–24, treatment emergent adverse events and infections were reported in 74.5% and 42.1% of BARI pts and 62.1% and 28.3% of PBO pts, respectively. Serious adverse events were reported in 2.8% of pts in both groups. There was 1 nonserious esophageal candidiasis in the BARI group for Week 0–24. Four herpes zoster events (1 PBO, 3 BARI) were reported for Week 0–24. No major cardiovascular events, deaths, tuberculosis, venous thromboembolic events or malignancies were reported in the study through Week 24 for PBO and through Week 52 for BARI group. No unexpected safety signals were observed.Table 1Study RA-BALANCE efficacy measuresConclusions:Compared to PBO, BARI provided significant improvements in control of signs and symptoms, including pain and physical function with an acceptable safety profile.Disclosure of Interest:Z. Li Consultant for: Advisory board member of baricitinib, J. Hu: None declared, C. Bao Consultant for: Advisory board member of baricitinib, X. Li Consultant for: Advisory board member of baricitinib, X. Li Consultant for: Advisory board member of baricitinib, J. Xu: None declared, A. Spindler: None declared, X. Zhang Consultant for: Advisory boa...

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

“…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). The results from the current analysis are consistent with previously published integrated safety reported in a Japanese population and also with RA‐BALANCE (NCT02265705) study conducted primarily in a Chinese population with moderate‐to‐severely active RA . Recently, the RA‐BALANCE study demonstrated rapid and durable efficacy results with baricitinib 4 mg once daily compared to placebo in patients with inadequate response to MTX.…”

“…The occurrence of clinically important safety outcomes, including serious infections, was similar between both groups. No unexpected safety signals were observed . This analysis is further confirmed by the data from LTE study with a broader EA population.…”

Comparative Efficacy of JAK Inhibitors for Moderate-To-Severe Rheumatoid Arthritis: A Network Meta-Analysis

“…All approved JAK inhibitors were more efficacious than csDMARDs with 95% probability. At both time points, upadacitinib 15 mg QD monotherapy and in combination with csDMARD consistently demonstrated numerically higher responses in terms of ACR 20/50/70 and DAS28-CRP remission among patients with csDMARD-IR RA compared with other JAK inhibitors [39].…”

Letter to the Editor Regarding Comparative Efficacy of JAK Inhibitors for Moderate-to-Severe Rheumatoid Arthritis: A Network Meta-Analysis

“…Thirdly, inclusion of trials allowing for lower background dose of methotrexate (MTX) in the network might also constitute another source of heterogeneity, the impact of which on treatment response has not been reported. We specifically refer here to the inclusion of RA-BALANCE [ 4 ] and SELECT-SUNRISE [ 5 ], in some of the networks, where the dosage of MTX was much lower than that reported in other included trials in the networks. Trials including Asians-Japanese patients with lower MTX dose should have been excluded in a sensitivity analysis and impact on results compared.…”