Baricitinib (Olumiant) should be used with caution in patients with diverticular disease, regulators in the UK have advised

The drug safety update from the Medicines and Healthcare products Regulatory Agency (MHRA) also says the JAK inhibitor should also be used in caution in patients concomitantly treated with medications associated with an increased risk of diverticulitis such as NSAIDs. 

“Advise patients on baricitinib to seek immediate medical care if they experience severe abdominal pain especially accompanied with fever, nausea and vomiting or other symptoms of diverticulitis,” the update notes. 

In clinical trials of baricitinib to treat rheumatoid arthritis, there were 21 cases of diverticulitis (including 3 [14%] with a complication of gastrointestinal perforation) in 3770 patients across 13,380 patient-years of observation (incidence rate 0.16 per 100 patient-years [95% CI 0.10–0.24]).

For post-marketing use of baricitinib outside of clinical trials, 35 spontaneous cases of diverticulitis have been reported worldwide up to 31 December 2019, the update said. 

Baricitinib is listed on the PBS for the treatment of rheumatoid arthritis in adults.