RA Treatment; Baricitinib 4 mg Dose Found to Be Associated With Significantly Higher Risk of SAEs Than 2 mg Dose

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RA Treatment; Baricitinib 4 mg Dose Found to Be Associated With Significantly Higher Risk of SAEs Than 2 mg Dose

According to Feng Huang and Zu-chun Luo, scientists at Guangxi Medical University in China, the Baricitinib 2 mg shows minor adverse events than 4 mg dose at the follow up of 12 weeks. The Food and Drug Administration-based Advisory Committee on 23 April 2018 approved 2 mg Baricitinib for rheumatoid arthritis management and presented a likelihood of serious adverse events if the dose reached to 4 mg.

Therefore, this study was directed to compare the risk of adverse events associated with Baricitinib 2 mg versus 4 mg systematically.

The appropriate English publications were searched using electronic databases MEDLINE, EMBASE, Cochrane library, and ClinicalTrials.gov until April 2018. Clinical endpoints for the analysis were the adverse drug events at 12 weeks and 24 weeks. The obtained risk ratios (RR) and 95% CI were estimated using RevMan 5.3 software.

A total of four trials comprising 959 participants were analyzed. No difference between both Baricitinib doses was observed at 12 week regarding serious adverse events, discontinuation of drugs due to adverse events, any adverse events after the start of therapy, major adverse cardiac events, and malignancies. The other infections such as herpes zoster also showed similarly. However, 4 mg Baricitinib dispensed considerably higher adverse severe events than 2 mg at 24 weeks. Though, total adverse events following the start of therapy, major adverse cardiac events, infections including herpes zoster, malignancies, serious infections, and discontinuation of the drug due to adverse events showed no significant variations between the two doses of Baricitinib. However, additional large trials with more extended follow-up time periods are needed to validate the findings.

Source:

BioDrugs

Link to the source:

https://link.springer.com/article/10.1007%2Fs40259-018-0304-3

Original title of article:

Risk of Adverse Drug Events Observed with Baricitinib 2 mg Versus Baricitinib 4 mg Once Daily for the Treatment of Rheumatoid Arthritis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Authors:

Feng Huang and Zu-chun Luo

SearchTags: 
Therapeutic, Baricitinib, Rheumatoid Arthritis, Joints, JAK Inhibitor, Systematic Review and Meta-Analysis, Safety
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