In a nutshell
This study analyzed the risk of infections for patients with rheumatoid arthritis (RA) treated with baricitinib (Olumiant).
The study showed that there is a higher risk of non-serious infections in patients taking baricitinib.
Some background
RA is a chronic inflammatory auto-immune disease affecting the whole body. Baricitinib belongs to the group DMARD (disease-modifying antirheumatic drugs) which is increasingly used to treat RA. It is a Janus-Kinase inhibitor (JAK). It works by suppressing the activity of the immune system. This calms down the inflammation and eases the symptoms of RA. Because of the nature of RA, all patients are at higher risk of infection. This makes it important to understand the risk of a drug to cause infection as a side effect.
Previous studies have proven baricitinib to lower inflammation and ease the symptoms of RA. However, the risk and side effects like infections caused by the drug have not yet been explored enough.
Methods & findings
The study analyzed the results of 9 different trials with a total of 3492 patients. All 9 trials used baricitinib for patients with RA over an average period of 2.6 years and up to 6.1 years. In 6 of the 9 trials, a placebo was given for comparison.
The authors looked at the side effects caused by baricitinib like Herpes Zoster (HZ) and tuberculosis (TB). The frequency of infections and severity were noted.
There was a significantly higher risk to get infections like HZ in patients taking baricitinib 4mg compared to placebo. However, this risk was not significantly higher in patients taking baricitinib 2mg. Most of the HZ infections were mild to moderate. 12% of patients experienced serious HZ infections.
The risk of severe infections did not increase significantly with baricitinib compared to placebo. From all 3492 patients, 11 patients got TB which was assumed to be related to baricitinib 4 mg.
The bottom line
The authors concluded that baricitinib may increase the risk of infections as a side effect. They note that this is a common side effect in most RA treatment drugs. They recommend a TB screening and HZ vaccination for patients above 50 years of age before starting baricitinib therapy.
The fine print
Most of the patients included in the placebo groups also took another RA drug. Therefore, the results should be carefully interpreted.
What’s next?
Talk to your doctor about side effects and the risk of infection with baricitinib.
Published By :
Annals of the rheumatic diseases
Date :
Aug 11, 2020
