How Is Guselkumab Dosed in IBD?

In this medication review video module, Anne Feldman, NP, from the Cleveland Clinic Foundation, provides an in-depth overview of Guselkumab, an FDA-approved treatment for moderately to severely active ulcerative colitis. Anne explains the mechanism of action of Guselkumab, which is a dual-action monoclonal antibody that targets key pro-inflammatory proteins and their receptors, disrupting the inflammatory cascade responsible for chronic inflammation in conditions like ulcerative colitis, psoriasis, and psoriatic arthritis.

This monoclonal antibody therapy works by inhibiting the IL-23 protein, which plays a pivotal role in immune system activation and inflammation. Guselkumab reduces disease activity and promotes tissue healing by blocking the effects of IL-23, making it an effective treatment option for patients with ulcerative colitis.

Anne also outlines the dosing regimen for Guselkumab, starting with induction doses of 200 mg IV at weeks 0, 4, and 8, followed by maintenance doses either 200 mg every 4 weeks or 100 mg every 8 weeks, depending on the patient's response. It is administered in an infusion center, taking approximately one hour per infusion. Guselkumab is soon expected to be FDA-approved for Crohn’s disease, offering a first-line advanced therapy option or as a subsequent therapy after failure of other treatments.

Safety considerations are highlighted, including the need for vaccination and tuberculosis screening prior to starting the therapy. Patients on Guselkumab should avoid live vaccines due to its potential to suppress the immune system, which can increase the risk of infections. Common side effects include respiratory infections, sore throat, headaches, and injection site reactions. Guselkumab is not approved for use in pediatric patients (under 18 years of age), and its safety during pregnancy or breastfeeding is not fully established.

This detailed review provides essential information for healthcare providers and patients considering Guselkumab as part of their treatment for ulcerative colitis and other autoimmune diseases. For further information, visit the GHAPP website or download the GHAPP ACE app.