GHAPPcast

Thank you to Johnson & Johnson for the support on this FAQ Video Module.

In this FAQ video module, Tedra Gray, a gastroenterology nurse practitioner at Sinai Chicago, breaks down the key differences between treat-through and randomized withdrawal clinical trial designs in inflammatory bowel disease (IBD). This educational overview explains how these two study designs impact the evaluation of new IBD therapies, including their role in assessing safety, efficacy, and long-term patient outcomes. Viewers will learn how treat-through trials randomize patients at baseline to receive either active treatment or placebo throughout the study, offering insights into real-world effectiveness from induction through maintenance. In contrast, randomized withdrawal designs focus on patients who initially respond to therapy, re-randomizing them to continue treatment or switch to placebo—allowing for more efficient study design, reduced placebo exposure, and a focus on maintenance of response.

This video also explores key considerations such as population selection, ethical implications, study objectives, and how these designs are applied in major Phase 3 IBD trials like ASTRO, GRAVITI, GALAXY, and QUASAR. Ideal for gastroenterology providers and advanced practice providers, this content provides practical insights into interpreting clinical trial data and optimizing treatment strategies in IBD.

For more expert-driven GI education, visit the GHAPP Digital Hub and GHAPP ACE app.

Thank you to Johnson & Johnson for the support on this Medication Review Video Module.

In this medication review video module, Kimberly Orleck, PA-C, reviews the long-term efficacy and safety of guselkumab in the treatment of Crohn’s disease, highlighting results from the Phase 3 GALAXI-2, GALAXI-3, and GRAVITI clinical trials and their long-term extension (LTE) data through week 96. The discussion examines outcomes following intravenous (IV) or subcutaneous (SC) induction therapy followed by SC maintenance dosing, demonstrating sustained clinical remission, endoscopic response, endoscopic remission, and deep remission across study populations. The module also reviews steroid-free outcomes and emphasizes the durability of response observed over two years of treatment, with high rates of patients maintaining remission. Safety data across the LTE studies showed a stable safety profile with no new safety signals and low rates of serious adverse events and infections, consistent with the known safety profile of guselkumab.

This expert overview provides clinicians and advanced practice providers with important insights into long-term treatment outcomes and real-world implications for managing moderate-to-severe Crohn’s disease with IL-23 pathway inhibition.For more gastroenterology and hepatology educational content, visit the GHAPP Digital Hub and GHAPP ACE app.

In this podcast, host Amanda Mixon, PA-C, leads a 2026 Fireside Chat exploring the intersection of rheumatology and gastroenterology. Joined by Kim Orleck, PA-C (GI APP), and Wendy Simmons, PA-C (Rheumatology APP), the panel discusses the shared inflammatory pathways linking Crohn’s disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis, with a focus on the gut–joint–skin axis and the IL-23, IL-17, and TNF pathways.

The conversation highlights early screening for overlapping immune-mediated inflammatory diseases (IMIDs), recognizing subclinical gut inflammation, and selecting cross-indication therapies such as JAK inhibitors and IL-23 inhibitors based on disease severity, comorbidities, and cardiovascular risk. Listeners will gain practical insights into biomarker use (including fecal calprotectin), second-line treatment strategies after TNF failure, and the importance of real-time collaboration between rheumatology and GI providers to optimize patient outcomes.

For more educational content, visit the GHAPP Digital Hub or GHAPP ACE app.

Thank you to AbbVie for the support on this Journal Club Review Video Module.

In this journal club review, Kimberly Orleck, PA-C, discusses the long-term efficacy and safety of risankizumab, an IL-23 p19 inhibitor, in moderate to severely active Crohn’s disease, highlighting results from the FORTIFY maintenance trial and its open-label extension. Data show strong Week 52 clinical remission and endoscopic response and remission rates in both biologic-naïve and biologic-experienced patients, many with prior biologic failure, reinforcing the importance of treat-to-target goals and STRIDE-II recommendations. Long-term findings out to 276 weeks demonstrate sustained clinical and endoscopic outcomes with a favorable safety profile and no new safety signals over four years. The review also covers updated 2025 ACG and AGA guideline positioning and real-world U.S. claims data showing lower treatment switch rates and healthcare utilization with risankizumab compared to other advanced therapies, underscoring its role in evolving Crohn’s disease management. For more educational content, visit the GHAPP digital hub and GHAPP ACE app.

Thank you to AbbVie for the support on this podcast episode.

In this GHAPP podcast episode, Brooke Hodnik, PA, and Jamie Brogan, APRN, discuss the October 10, 2025 FDA label update for upadacitinib in adults with moderate to severe ulcerative colitis and Crohn’s disease. They break down what the expanded indication means in practice, including how clinicians should interpret terms like “clinically inadvisable” and “approved systemic therapy,” and how this update allows for more individualized treatment decisions beyond mandatory prior TNF exposure in certain scenarios. The conversation highlights key considerations such as high inflammatory burden in IBD, steroid-refractory disease, low albumin, immunogenicity concerns, and real-world barriers to biologic therapy. Brooke and Jamie emphasize the importance of clinical judgment, earlier access to appropriate advanced therapy when needed, and the goal of reducing hospitalizations, surgery risk, and long-term complications—ultimately improving quality of life for patients with moderate to severe IBD.

For more educational content visit GHAPP.org, the GHAPP Digital Hub or the GHAPP ACE app.

Thank you to Fujifilm for their support on this FAQ Video Module.

In this FAQ video module, Patrick Horne, NP, President of GHAPP and nurse practitioner at the University of Florida, provides a clear, practical overview of FDA-cleared biomarkers used in the detection and risk assessment of hepatocellular carcinoma (HCC). This discussion walks through key blood-based tests including AFP-L3, des-gamma-carboxy prothrombin (DCP), and how these markers—when combined with patient age and sex—are used to calculate the GALAD score to estimate the probability of HCC. The video also introduces newer diagnostic approaches such as the HelioLiver LDT, which evaluates tumor-associated DNA methylation patterns, and the Oncoguard-Liver test, a multi-target liquid biopsy analyzing both protein biomarkers and cancer-associated DNA. Designed for clinicians involved in liver disease management, this module highlights how FDA-cleared biomarkers can support earlier detection, improved risk stratification, and informed clinical decision-making in patients at risk for liver cancer.

Visit GHAPP.org, the GHAPP Digital Hub, and the GHAPP ACE app for additional gastroenterology and hepatology education and resources.

Thank you to AbbVie for their support on this FAQ Video Module.

In this FAQ video module, Brooke Hodnick, PA-C, breaks down key updates to the expanded upadacitinib label for adults with moderate to severe ulcerative colitis and Crohn’s disease, effective October 10, 2025. The discussion focuses on what qualifies as an “approved systemic therapy” in the context of patients who have had an inadequate response to prior treatments or for whom TNF inhibitors are clinically inadvisable. Viewers will gain clarity on FDA-approved systemic therapies for induction and maintenance of remission, including TNF inhibitors, anti-integrins, IL-12/23 and IL-23 inhibitors, JAK inhibitors, and S1P modulators, as well as important distinctions around therapies such as steroids and immunomodulators that are commonly used but not FDA-approved as systemic maintenance options. The conversation also highlights the role of clinical judgment, individualized risk–benefit assessment, and current guidance from organizations such as the American College of Gastroenterology and the American Gastroenterological Association.

For more educational information, please visit GHAPP.org, the GHAPP Digital Hub or the GHAPP ACE app.

Thank you to AbbVie for their support on this FAQ Video Module.

In this FAQ video module, Jamie Brogan, APRN from the IBD Center at Northwestern Medicine, breaks down the October 2025 FDA label expansion for upadacitinib in adult patients with moderate to severely active ulcerative colitis and Crohn’s disease. The discussion focuses on the updated indication for patients with an inadequate response or intolerance to TNF inhibitors—and importantly, the newly emphasized language around when TNF therapy may be considered “clinically inadvisable.” Jamie explores what this term means in real-world clinical practice, including patient-specific factors such as contraindications to TNF agents, need for rapid onset of action, prior treatment exposure, comorbidities, and access or adherence challenges. She shares practical insights on how this label expansion has impacted IBD management, increased treatment access, and supported individualized, risk-benefit decision-making between providers and patients.

Thank you to Madrigal for their support on this FAQ Video Module.

In this FAQ video, Allysa Saggese, NP, reviews how clinicians can balance systemic and liver-directed therapies in the treatment of metabolic dysfunction–associated steatohepatitis (MASH) and shares insights on the evolving role of combination therapy. The discussion explores current guideline-aligned options, including GLP-1–based systemic therapies and liver-directed agents, and emphasizes individualized treatment decisions based on fibrosis stage, metabolic comorbidities, patient preferences, and access considerations. Designed for APPs and clinicians, this overview highlights why multimodal therapy—alongside lifestyle interventions like diet and exercise—is likely the future of MASH management.

Thank you to Madrigal for their support on this FAQ Video Module.

In this FAQ video, Alison Moe, PA-C, discusses how alcohol consumption impacts the evaluation and progression of metabolic dysfunction–associated steatohepatitis (MASH) and why accurate assessment is critical in clinical practice. The discussion reviews the synergistic effects of alcohol and metabolic liver disease on fibrosis progression, explains current alcohol intake thresholds associated with increased risk, and outlines how biomarkers such as phosphatidylethanol (PEth) can provide objective insight into recent alcohol use. Designed for APPs and clinicians, this practical overview highlights how to differentiate MASH, alcohol-related liver disease (ALD), and MetALD to ensure accurate diagnosis, documentation, and treatment decisions.