Abstract
Objective
This study aimed to evaluate the safety and effectiveness of baricitinib in patients with systemic lupus erythematosus (SLE).
Methods
We searched MEDLINE, EMBASE, and the Cochrane Controlled Trials Register to find relevant publications. Using data from randomized controlled trials (RCTs), we performed a meta-analysis to investigate the safety and efficacy of baricitinib in patients with active SLE who did not respond well to standard treatments.
Results
A total of 1849 individuals (1235 experimental participants and 614 controls) from three RCTs on baricitinib were included. A reduction of ≥ 4 points from baseline in SLEDAI-2K score in the baricitinib 4 mg group was greater than the placebo group’s reduction (odds ratio [OR] = 1.407, 95% confidence interval [CI] 1.123–1.763, p = .003). The baricitinib 4 mg group significantly outperformed the placebo group in terms of SLEDAI-2K remission of arthritis or rash (OR = 1.327, 95% CI = 1.059–1.663, p = .014). Other effectiveness outcomes such as the SRI4 response did not substantially improve in the baricitinib 4 mg group when compared with the placebo group. And there were no significant increase in the efficacy outcomes in the baricitinib 2 mg group than in the placebo group. However, there was a substantially higher incidence of severe adverse events (SAE) and serious infections in the baricitinib 4 mg group (OR = 1.493, 95% CI = 1.002–2.225, p = .049; OR = 2.303, 95% CI = 1.147–4.622, p = .019) compared to the placebo group. There were no differences between the baricitinib 2 mg and placebo groups in any of the safety outcome data.
Conclusion
Meta-analysis reveals that baricitinib 4 mg is beneficial for treating active SLE in terms of a reduction of ≥ 4 points from baseline in SLEDAI-2K score and SLEDAI-2K remission of arthritis or rash. However, the higher frequency of SAEs and serious infections was observed in the group receiving baricitinib 4 mg.
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