Safety Of Baricitinib Research Articles

Efficacy and safety of baricitinib in Japanese patients with active rheumatoid arthritis: A 52-week, randomized, single-blind, extension study

Objectives: The objective of this study is to evaluate the efficacy and safety of long-term (64 weeks; 52-week extension of a 12-week study) baricitinib treatment in Japanese patients with active rheumatoid arthritis (RA) despite methotrexate therapy.Methods: Patients (N = 145) with active RA were randomized to placebo, 1mg, 2mg, 4mg, or 8mg baricitinib for the first 12 weeks. During the 52-week extension period, patients on 4mg or 8mg baricitinib remained on the same dose and all other patients were re-randomized to 4mg or 8mg baricitinib. Most patients on 8mg baricitinib were switched to 4mg by week 64 (protocol amendment); data analysis was based on the treatment group at the beginning of the extension period.Results: Increases in the American College of Rheumatology (ACR) response rates (ACR20, ACR50, and ACR70) observed during the first 12 weeks were maintained during the extension period, accompanied by improvements in ACR core components. At week 64, a large proportion of patients (>40%) had low disease activity. Most treatment-related adverse events were mild or moderate; herpes zoster was the most common reason (11/27 patients) for discontinuation.Conclusions: The efficacy and safety profile of baricitinib was maintained during long-term treatment of Japanese patients with RA and background methotrexate therapy.Clinicaltrials.gov NCT01469013; Funding: Eli Lilly and Incyte

Comparative efficacy and safety of baricitinib 2 mg and 4 mg in patients with active rheumatoid arthritis : ABayesian network meta-analysis of randomized controlled trials.

This study aimed to assess the relative efficacy and safety of once-daily baricitinib 2 mg and 4 mg administration in patients with active rheumatoid arthritis (RA). In this network meta-analysis, randomized controlled trials (RCTs) examining the efficacy and safety of baricitinib in patients with active RA were included. ABayesian network meta-analysis was conducted to combine the direct and indirect evidence from the RCTs. Seven RCTs involving 3461patients met the inclusion criteria. There were ten pairwise comparisons, including seven direct comparisons and five interventions. The ACR20response rate was significantly higher in the baricitinib 4 mg in combination with disease-modifying antirheumatic drugs (DMARD) group than in the placebo+DMARD group (odds ratio, OR 3.13; 95% credible interval, CrI 2.32-4.33). Compared with the placebo+DMARD group, the baricitinib 4 mg, baricitinib 2 mg + DMARD, and adalimumab 40 mg + methotrexate (MTX) groups showed asignificantly higher ACR20 response rate. The ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that baricitinib 4 mg + DMARD was likely to elicit the best ACR20 response rate (SUCRA= 0.7930), followed by baricitinib 4 mg (SUCRA= 0.7034), baricitinib 2 mg + DMARD (SUCRA= 0.6304), adalimumab 40 mg + MTX (SUCRA= 0.3687), and placebo+DMARD (SUCRA= 0.0045). By contrast, the safety based on the number of treatment-emergent adverse events (TEAEs) did not differ significantly among the five interventions. Baricitinib 2 mg and 4 mg administered once daily, in combination with DMARD, were efficacious interventions for active RA that had no significant risk of TEAE development.

Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study.

Efficacy and Safety of Baricitinib in Japanese Patients with Active Rheumatoid Arthritis Receiving Background Methotrexate Therapy: A 12-week, Double-blind, Randomized Placebo-controlled Study.

O51 Efficacy and Safety of Baricitinib in Patients with Active Rheumatoid Arthritis and Inadequate Response to <sc>cs</sc>Dmards: Summary Results from the 24-Week Phase III RA-Build Study

O51 Efficacy and Safety of Baricitinib in Patients with Active Rheumatoid Arthritis and Inadequate Response to <sc>cs</sc>Dmards: Summary Results from the 24-Week Phase III RA-Build Study

078 Efficacy and Safety of Baricitinib in Patients with Active Rheumatoid Arthritis and Inadequate Response to Tumour Necrosis Factor Inhibitors: Summary Results from the 24-Week Phase III RA-Beacon Study

078 Efficacy and Safety of Baricitinib in Patients with Active Rheumatoid Arthritis and Inadequate Response to Tumour Necrosis Factor Inhibitors: Summary Results from the 24-Week Phase III RA-Beacon Study

THU0149 Efficacy and Safety of Baricitinib in Japanese Rheumatoid Arthritis Patients at 12 Weeks

BackgroundBaricitinib, a novel, oral inhibitor of JAK1/JAK2 in the JAK-STAT signaling pathway, was evaluated in a blinded Phase 2b study in Japanese patients (pts) with rheumatoid arthritis (RA) with an...