‘Acceptable’ 2-year safety profile of baricitinib in RA patients
medwireNews: The Janus kinase (JAK) inhibitor baricitinib has a favorable safety profile over a median 2 years of exposure in patients with rheumatoid arthritis (RA), researchers report.
Using an integrated database including 3492 baricitinib-treated patients who participated in eight trials and one long-term extension study, Josef Smolen (Medical University of Vienna, Austria) and colleagues demonstrated no significant difference in the risk for death, malignancy, major adverse cardiovascular events, and adverse events leading to treatment discontinuation among patients treated with baricitinib 4 mg once daily versus placebo.
However, “[i]nfection risk, particularly for herpes zoster, [was] elevated as with other JAK inhibitors,” say the investigators. Exposure-adjusted incidence rates for treatment-emergent infections were 88.4 per 100 patient–years for baricitinib 4 mg, and 75.9 per 100 patient–years for placebo, while the corresponding rates of herpes zoster infection were 4.3 versus 1.0.
“[C]linicians should take steps to prevent and monitor for such infections,” write Smolen and team, adding that herpes zoster vaccination for certain patients prior to starting JAK inhibitor therapy “may be a therapeutic option.”
And they conclude in The Journal of Rheumatology that overall, “baricitinib has an acceptable safety profile in the context of demonstrated efficacy.”
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