Guselkumab in Patients With Moderately to Severely Active Ulcerative Colitis

In this Journal Club video module, Shayla Scheonoff, a physician assistant from Rochester, Minnesota, provides a comprehensive review of the efficacy and safety of Guselkumab induction therapy for moderately to severely active ulcerative colitis (UC). Sponsored by Johnson & Johnson, this detailed analysis covers both the Phase 2B and Phase 3 QUASAR induction studies for Guselkumab, a dual-acting IL-23 p19 subunit inhibitor that blocks IL-23 and binds to CD64 on cells that produce IL-23. Previously approved for psoriasis and psoriatic arthritis, Guselkumab has shown remarkable promise as a treatment for ulcerative colitis.

The Phase 2B study involved 313 patients with severe UC who had failed previous therapies. Results showed that 61% of patients receiving Guselkumab 200 mg and 60% of patients receiving Guselkumab 400 mg achieved a clinical response at 12 weeks, significantly outperforming the placebo group, where only 27% responded. The study also demonstrated that Guselkumab was well-tolerated, with a 1% rate of serious adverse events compared to 5.7% in the placebo group. The Phase 3 QUASAR study further confirmed Guselkumab's effectiveness, with 22.6% of patients achieving clinical remission at week 12, compared to 7.9% in the placebo group. Secondary endpoints like symptomatic remission, endoscopic improvement, and histologic improvement also showed significant benefits for patients on Guselkumab.

The Guselkumab induction therapy demonstrated consistent safety profiles in both studies, with similar rates of infection and serious infections across both treatment and placebo arms. This Journal Club video provides an in-depth look at the promising results of Guselkumab in treating moderately to severely active ulcerative colitis, offering an innovative therapy option for patients who have not responded to traditional treatments.

For more information on Guselkumab and its role in the treatment of ulcerative colitis, visit the GHAPP website or GHAPP ACE mobile app and access additional resources tailored for advanced practice providers.