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Baricitinib (Olumiant?): increased risk of diverticulitis, particularly in patients with risk factors

Medicines Healthcare Products Regulatory Agency

August 26
13:08 2020

Advice for healthcare professionals:

  • cases of diverticulitis and gastrointestinal perforation have been reported in patients taking baricitinib

  • most, but not all, cases of diverticulitis occurred in patients who were concomitantly taking medicines associated with an increased risk of diverticulitis

  • use caution in patients with pre-existing diverticular disease and in patients on long-term concomitant medications associated with an increased risk of diverticulitis such as non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, and opioids

  • 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

  • ensure prompt evaluation of any patients on baricitinib who present with new-onset abdominal signs and symptoms to identify early diverticulitis or gastrointestinal perforation

  • report any suspected adverse drug reactions to black triangle medicines to the Yellow Card scheme

Review of increased risk of diverticulitis

Baricitinib (Olumiant?) is a Janus kinase (JAK) inhibitor drug first authorised in the EU in February 2017. It is authorised 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.

Cases in clinical trials

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 0.100.24]).

Of the 21 patients, 7 (33%) had diverticulosis or diverticulitis noted in their medical history. For concomitant medicines, 13 (62%) of the 21 patients were on chronic corticosteroid treatment, 9 patients were chronically treated with NSAIDs, and 4 patients with acetylsalicylic acid (aspirin) medications.

Cases of diverticulitis and diverticulosis were also reported in clinical trials of baricitinib for other conditions not authorised in the UK. Overall, the observed frequency of diverticulitis in baricitinib use in clinical trials was 0.43% (uncommon).

Cases in post-marketing use

For post-marketing use of baricitinib outside of clinical trials, 35 spontaneous cases of diverticulitis have been reported worldwide up to 31 December 2019. Of these, 25 (71%) cases specifically included a medical history of diverticulitis and/or chronic use of NSAIDs, corticosteroids or opioids, which are known important risk factors for diverticulitis. However, 10 cases had no pre-existing conditions or use of concomitant medications as confounding factors. Gastrointestinal perforation as a complication of diverticulitis was reported in 5 (14%) cases. None of the cases were fatal.

The time to onset of clinical trial and post-marketing cases ranged from 6 days to 6 years. The majority of cases occurred after more than 90 days of treatment.

Report any suspected adverse drug reactions

Baricitinib (Olumiant ?) is a black triangle medicine and any suspected adverse drug reactions (ADRs) should be reported to the Yellow Card scheme.

Reporting suspected ADRs, even those known to occur, adds to knowledge about the frequency and severity of these reactions and can be used to identify patients who are most at risk. Your report helps the safer use of medicines.

Article citation: Drug Safety Update volume 14, issue 1: August 2020: 4.?

Published 26 August 2020

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