Baricitinib is a Janus kinase (JAK) inhibitor used for the treatment of moderate to severe active rheumatoid arthritis in adults who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
A European review has assessed cases of diverticulitis associated with baricitinib reported in clinical trials and in clinical (post-marketing) use worldwide. The risk of diverticulitis has been added to the product information for baricitinib with an uncommon frequency and healthcare professionals are asked to use caution in patients at risk of this condition.
Diverticulitis is also a potential side effect of tofacitinib (Xeljanz), another JAK inhibitor indicated for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Prescribers of tofacitinib should exercise the same caution in patients with risk factors for diverticulitis.
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.
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