What Is the Safety Profile of Guselkumab in Ulcerative Colitis and Crohn's Disease?

In this medication review module, Peter Byrne, FNP at South Denver Gastroenterology, discusses the safety of guselkumab in the treatment of Ulcerative Colitis and Crohn's disease. The Quasar trial, a phase 3 double-blind study, evaluated the safety of guselkumab in patients with inadequate responses to conventional therapies. Results showed that the incidence of serious adverse events was lower in the guselkumab group (2.9%) compared to placebo (7.1%), with a minimal occurrence of serious infections (less than 1%) in both groups. The safety profile of guselkumab was consistent with known data from plaque psoriasis and psoriatic arthritis studies.

In the Galaxy 1 trial for Crohn’s disease, serious adverse events were similar across treatment groups, with infection rates at 15.1% for guselkumab and 21.4% for placebo. One notable event in the guselkumab group was toxic hepatitis, which was reversible after treatment and discontinuation of the drug. Serious infections such as viral gastroenteritis and anal abscesses occurred in the guselkumab group but were determined not to be drug-related. Both trials reported no deaths, no active tuberculosis, and no opportunistic infections. The most frequent infections reported were upper respiratory infections and nasopharyngitis. The data suggests that guselkumab maintains a favorable safety profile for patients with inflammatory bowel diseases. For additional information, visit the GHAPP website or download the GHAPP ACE mobile app.