Baricitinib for lupus?
The final topic was baricitinib (Olumiant).
There were modest indications of benefit at 4 mg/day oral after 6 months in a phase 2 trial with 314 people. There were also serious infections in 6% versus 2% on 2 mg/day and 1% on placebo. One patient in the 4-mg/day arm (1%) developed deep vein thrombosis (DVT), but they were positive for antiphospholipid antibodies, which raise the clot risk.
Baricitinib is FDA approved as second line at 2 mg/day for adult rheumatoid arthritis; there’s a black box warning of malignancies, thrombosis, and serious infections.
“I’m not sure” the risk-benefit is in the right direction for baricitinib in lupus. “There were a significant number of serious infections ... for not a lot of effect on” disease activity, tweeted the Twitter chat coleader, Dr. Schmajuk. In a separate tweet, she said that, even in nonlupus patients, “we are avoiding [Janus kinase inhibitors] in patients with DVT risk factors. If I were a patient, [I’m] not sure I would want to take the risk.”
“Future studies with larger sample size and longer follow up ... are needed to address some of the concerns related to DVT,” said Zahi Touma, MD, an assistant professor of rheumatology at the University of Toronto.