Long-term treatment with baricitinib is well tolerated for active rheumatoid arthritis says new study

Despite an elevated infection risk, particularly for herpes zoster, baricitinib (an oral, once-daily selective Janus kinase inhibitor) is generally well-tolerated in people with moderate to severe active rheumatoid arthritis, according to a study in the Journal of Rheumatology.

Experts looked at baricitinib’s safety profile over 5.5 years. An “all-bari-RA” group included 3,492 people who received any baricitinib dose. They were split into people on 4mg and those taking a lower dose of 2mg, and there was a placebo group.

Those who took 4mg baricitinib were compared with people who took 2mg of baricitinib or a placebo. They experienced no differences in rates of death, adverse events leading to drug discontinuation, malignancies, major adverse cardiovascular event, or serious infections.

But infections including herpes zoster were significantly more frequent for 4mg baricitinib versus placebo.

“Throughout its development, baricitinib was generally well tolerated,” the authors say. “Infection risk, particularly for herpes zoster, is elevated as with other JAK inhibitors, and clinicians should take steps to prevent and monitor for such infections. Long-term risks of malignancy need further study, but currently there is no signal suggesting an increased risk. The potential risk for deep vein thrombosis/pulmonary embolism warrants further characterization, including in the postmarketing setting.”

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