GHAPPcast

FAQ: Phase 3 GALAXI 2 & 3: Extraintestinal Manifestations In Moderate to Severe Crohn’s Disease

Thank you to J&J for the support of this FAQ Video Module.This FAQ video features Janette Villalon, PA, who reviews the role of guselkumab in treating extraintestinal manifestations in patients with moderately to severely active Crohn’s disease. In this expert-led discussion, she summarizes findings from the GALAXI 2 and GALAXI 3 clinical trials presented at a 2026 medical congress, which used a treat-through study design intended to reflect real-world clinical practice. The focus of the analysis is on how patients with Crohn’s disease respond over time when treated with guselkumab compared to placebo. The data presented focuses on key outcomes such as improvement and resolution of extraintestinal manifestations, including joint and skin symptoms, along with measures like steroid-free remission and the emergence of new symptoms over time. At baseline, a notable proportion of patients in both the guselkumab and placebo groups had extraintestinal involvement, most commonly arthralgia, with skin manifestations occurring less frequently. This educational FAQ highlights how clinicians are evaluating guselkumab as part of a broader strategy for managing Crohn’s disease, with attention to both symptom control and durability of response over time. It provides practical insights for gastroenterology advanced practice providers and healthcare professionals as they balance effectiveness, long-term disease control, and comprehensive care of patients with inflammatory bowel disease in clinical practice. Visit the GHAPP Website, GHAPP Digital Hub or GHAPP ACE app for additional educational content.

Medication Review: Monotherapy vs. Combination Therapy: Relevance in IBD Treatment Strategy

This medication review explores the evolving role of monotherapy versus combination therapy in the treatment of inflammatory bowel disease (IBD), with a focus on biologic optimization and patient-centered treatment strategies. In this expert-led discussion, Brooke Hodnick, PA, from Texas Digestive Disease Consultants, reviews the clinical rationale behind combining biologic therapies such as infliximab with immunomodulators, including methotrexate and thiopurines, to reduce immunogenicity, improve biologic drug levels, and enhance long-term treatment outcomes in ulcerative colitis and Crohn’s disease. The presentation highlights pivotal clinical trials including SONIC and UC SUCCESS, which demonstrated improved remission rates and mucosal healing with combination therapy involving TNF inhibitors. Current recommendations from the American Gastroenterological Association (AGA) and American College of Gastroenterology (ACG) supporting infliximab combination therapy are also discussed. The review also examines the growing interest in biologic monotherapy approaches, particularly with subcutaneous infliximab formulations. Data from the LIBERTY Crohn’s and LIBERTY UC trials are explored, demonstrating stable and sustained pharmacokinetic drug concentrations through two years of treatment without the need for additional immunomodulators. This PK-driven monotherapy strategy may help reduce long-term immunosuppressive burden while maintaining efficacy in select patients with IBD. Important safety considerations are addressed, including infection risk, lymphoma risk, hepatosplenic T-cell lymphoma, and non-melanoma skin cancer associated with thiopurine use, especially in older adults and younger male patients receiving prolonged combination therapy. Learn how clinicians are balancing efficacy, safety, immunogenicity, and treatment simplification when selecting monotherapy versus combination therapy for ulcerative colitis and Crohn’s disease. This educational medication review provides practical insights for gastroenterology advanced practice providers and healthcare professionals managing complex IBD patients in clinical practice. Visit the GHAPP Website, GHAPP Digital Hub or GHAPP ACE app for additional educational content.

Medication Review: Stable PK Supporting Continuous Inflammatory Control

This medication review explores the role of stable pharmacokinetics (PK) in achieving continuous inflammatory control in inflammatory bowel disease (IBD), with a focus on subcutaneous infliximab therapy for Crohn’s disease and ulcerative colitis. Kim Orleck, PA-C, from Atlanta Gastroenterology Associates and United Digestive, reviews how subcutaneous infliximab provides more stable and sustained drug exposure compared with traditional intravenous (IV) infliximab dosing. By minimizing peak-to-trough fluctuations and maintaining higher trough concentrations, subcutaneous infliximab may help support continuous TNF inhibition, reduce immunogenicity risk, and improve long-term disease control in patients with moderate to severe IBD. The discussion highlights key clinical data from studies including REMSWITCH, LIBERTY Crohn’s, and LIBERTY UC, demonstrating that subcutaneous infliximab delivers durable remission, stable safety outcomes, and consistent therapeutic drug levels through long-term follow-up. Learn how transitioning from IV to subcutaneous infliximab may improve patient convenience, maintain clinical and endoscopic remission, and support treat-to-target goals in IBD management. The review also examines which patients may require closer monitoring or dose escalation strategies following the switch from IV biologic therapy. For more educational content visit the GHAPP Digital Hub and the GHAPP ACE app.

ASTRO Phase 3 Study: Efficacy and Safety of SC Guselkumab

Thank you to J&J for the support of this Journal Club Review Module. In this journal club video, Sharon Dudley Brown, CRNP, PhD, from the IBD Center at Johns Hopkins University, reviews the ASTRO trial published in The Lancet, which evaluated subcutaneous guselkumab for the treatment of moderate to severe ulcerative colitis. The discussion highlights how this IL-23 inhibitor was studied in patients with difficult-to-treat disease who had previously failed or were intolerant to standard therapies. The trial compared different dosing strategies of subcutaneous guselkumab versus placebo and assessed clinical remission, symptom improvement, and endoscopic outcomes over time. Results showed that patients receiving guselkumab had higher rates of remission and improved colon inflammation compared with placebo, with benefits seen early in treatment and sustained through follow-up. Safety outcomes were generally similar between groups, with no new safety concerns identified. Overall, the ASTRO trial supports subcutaneous guselkumab as an effective and well-tolerated option for patients with moderate to severe ulcerative colitis.

Journal Club: Benefit–Risk Profile of Upadacitinib in Patient’s With Moderate to Severe UC and CD

Thank you to AbbVie for the support of this Journal Club Review Module. This journal club review episode explores the benefit–risk profile of Upadacitinib for patients with moderately to severely active Ulcerative Colitis and Crohn’s Disease, based on a post hoc analysis of phase 2b/3 clinical trials. Featuring expert insights from Sally Bowa, APNP, FNP-C and Jennifer Labas, MSN, in both community and academic settings, this discussion breaks down real-world considerations including efficacy, safety outcomes, and long-term disease management. Key topics include rapid symptom relief, induction and maintenance of remission, and how upadacitinib compares to other advanced therapies in IBD treatment sequencing. The episode also highlights important safety considerations such as herpes zoster risk, cardiovascular events, and thrombosis, along with practical strategies like vaccination protocols, lab monitoring, and patient selection. Designed for gastroenterology and hepatology advanced practice providers, this episode provides actionable guidance on balancing risks and benefits, optimizing treatment decisions, and improving patient outcomes in complex IBD care. For more educational content, visit the GHAPP Digital Hub and the GHAPP ACE app.