GHAPPcast

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In this video, Jamie Brogan, NP, from Northwestern Medicine in Chicago, discusses the efficacy and safety of Guselkumab therapy for patients with moderate to severely active Crohn’s disease, highlighting results from the Galaxy 2 and Galaxy 3 trials. Guselkumab is a dual-acting IL-23p19 subunit inhibitor, designed to neutralize IL-23 and bind to the CD64 receptor, which plays a role in the production of IL-23.

The Galaxy 2 and 3 Phase 3 trials used a randomized, double-blind, double-dummy treat-through design to evaluate IV induction and subcutaneous maintenance therapy in Crohn’s patients. The co-primary endpoints included clinical response at Week 12 and clinical remission at Week 48, along with clinical response at Week 12 and endoscopic response at Week 48. Achieving endoscopic response is particularly significant, as it has been shown to reduce disease progression, flares, hospitalizations, and the need for surgery.

The study results showed strong efficacy for Guselkumab therapy. In Galaxy 2, 49% to nearly 55% of Guselkumab patients achieved clinical response at Week 12 and remission at Week 48, compared to 11.8% on placebo. In Galaxy 3, 46.9% and 48% of Guselkumab patients met the same criteria, compared to 12.2% on placebo. Additionally, Guselkumab met all secondary endpoints and demonstrated superiority to ustekinumab at Week 48 for endoscopic response, endoscopic remission, and deep remission.

The safety profile of Guselkumab therapy remained consistent and favorable. The most common adverse events reported were COVID-19, upper respiratory infections, Crohn’s disease worsening, arthralgia, and headache, with no deaths observed.

These results underscore Guselkumab’s potential as an effective maintenance therapy for Crohn’s disease. Watch this video for an in-depth analysis, and visit the GHAPP website or download the GHAPP ACE app for more details.

In this video, Allison Moser, a transplant hepatology nurse practitioner at Rush University Medical Center, discusses the key principles of shared decision-making and how healthcare providers can better support their patients in making informed choices about their care. Shared decision-making is a collaborative approach that prioritizes communication, respect, and patient autonomy, ensuring that treatment decisions align with the patient’s values and preferences.

Effective shared decision-making begins with active listening—understanding the patient’s concerns, goals, and priorities. It also involves clear communication, providing easy-to-understand explanations of treatment options, risks, and benefits. Visual aids and simple language can help improve comprehension, allowing patients to make well-informed decisions. Healthcare providers play a crucial role in guiding patients through their options, acknowledging uncertainties, and reassuring them that it’s okay to take time or seek second opinions.

By fostering a trusting partnership, providers can empower patients to take an active role in their health journey, leading to better engagement, satisfaction, and health outcomes. Watch the full video to learn how to implement shared decision-making in clinical practice. For more expert insights, visit the GHAPP website and subscribe for more healthcare discussions!

Thank you to Johnson & Johnson for your support of this Medication Review Video Module.

In this comprehensive medication review, Peter Byrne, FNP, from South Denver Gastroenterology, discusses the efficacy of guselkumab in treating ulcerative colitis (UC) and Crohn’s disease (CD) based on key clinical trials, including Quasar and Galaxy 1.

Guselkumab has demonstrated significant efficacy in treating both ulcerative colitis (UC) and Crohn’s disease (CD), as highlighted in key clinical trials, including Quasar and Galaxy 1. In the Quasar trial, a Phase 3, randomized, placebo-controlled study, 701 patients with moderate to severe ulcerative colitis who had an inadequate response or intolerance to conventional or advanced therapies were evaluated. Patients received IV guselkumab (200 mg) or placebo at Weeks 0, 4, and 8, with the primary endpoint being clinical remission at Week 12. Results showed that 22.6% of guselkumab-treated patients achieved clinical remission compared to 7.9% with placebo, while 61.5% of patients on guselkumab showed a clinical response versus 27.9% on placebo. Additionally, 23.5% achieved histologic-endoscopic mucosal improvement (HEMI) versus 7.5% with placebo. In the maintenance phase, clinical remission at Week 44 was 50% with higher-dose guselkumab, 45.2% with the lower dose, and 18.9% with placebo, confirming its sustained efficacy.

For Crohn’s disease, the Galaxy 1 Phase 2 trial assessed guselkumab in patients with moderate to severe Crohn’s disease through an IV induction phase followed by subcutaneous maintenance therapy. At Week 12, 53% of guselkumab-treated patients achieved clinical remission compared to 16.4% on placebo, while clinical response rates were 65.9% versus 24.6% on placebo. Endoscopic response, defined as at least a 50% reduction in SC-CD score, was observed in 35.7% of guselkumab patients compared to 11.5% with placebo. Notably, bio-naïve patients had even higher response rates, with 47.5% achieving clinical remission versus 10% on placebo. In the maintenance phase, patients were assigned different dosing regimens, with 64%-73% achieving clinical remission depending on the dosage, compared to 57% in the ustekinumab group. Additionally, 44%-46% of guselkumab-treated patients showed an endoscopic response, while 18%-33% achieved endoscopic remission, compared to 30% and 6% in the ustekinumab group, respectively.

Overall, guselkumab has shown strong efficacy and a favorable safety profile in both ulcerative colitis and Crohn’s disease, with superior clinical, endoscopic, and histologic response rates compared to placebo. The Quasar and Galaxy 1 trials support its potential as a promising treatment option for inflammatory bowel disease (IBD). For further insights, visit the GHAPP website or download the GHAPP ACE app for more educational content.

Sherona Bau, NP, at Pfleger Liver Institute, discusses the importance of providing effective care for patients with cirrhosis, which requires a proactive and comprehensive approach from healthcare providers, including physicians and advanced practice providers. Early diagnosis is crucial, as many patients with compensated cirrhosis remain asymptomatic. Using non-invasive testing, such as FibroScan or morphology imaging, can help identify liver damage and make a timely diagnosis.

Once cirrhosis is diagnosed, patient education becomes essential. Providers should emphasize the importance of abstinence from alcohol, as patients may unknowingly continue drinking if unaware of their condition. It is also vital to stress adherence to medications like lactulose to prevent complications such as hepatic encephalopathy. Additionally, patients should undergo liver cancer screening every six months through abdominal ultrasound and alpha-fetoprotein testing, as cirrhotic patients are at higher risk for liver cancer.

Preventive care, such as vaccinations for flu, hepatitis A, and hepatitis B, should also be part of the treatment plan. For patients whose cirrhosis is alcohol-related, referring them to addiction medicine can help address alcohol cravings and support long-term recovery. By fostering a non-judgmental, communicative approach, healthcare providers can build trust, encourage adherence to treatment plans, and ensure timely follow-up appointments. These steps can significantly improve care for patients living with cirrhosis. For more information visit the GHAPP website or download the GHAPP ACE mobile app.

Thank you to Johnson & Johnson for your support of this Medication Review Video Module.

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.

Thank you to Johnson & Johnson for your support of this Journal Club Video Module.

In this Journal Club video module, Jamie Brogan, NP, from Northwestern, discusses findings from the Phase 2 GALAXI-1 Study, which evaluated guselkumab, a selective IL-23p19 antagonist, for the treatment of moderate-to-severe Crohn’s disease. This randomized, placebo-controlled study assessed intravenous guselkumab at doses of 200 mg, 600 mg, and 1200 mg, alongside ustekinumab and placebo. At week 12, the results demonstrated significant reductions in Crohn’s Disease Activity Index (CDAI) scores among patients receiving guselkumab compared to those in the placebo group.

Clinical remission was achieved in up to 57% of patients who received the 200 mg IV dose, with additional improvements in biomarker and endoscopic responses. These findings support the 200 mg IV dosing regimen for Phase 3 clinical trials. For more details, visit the GHAPP website or download the GHAPP ACE mobile app for more educational content.

In this episode of GHAPPcast, Jordan Mayberry, a PA-C at UT Southwestern in Dallas, Texas, and Patrick Horne, a nurse practitioner from the University of Florida, dive deep into the support strategies for healthcare providers and patients managing chronic liver disease and cirrhosis.

As a healthcare provider, it’s essential to rely on a variety of resources to stay up-to-date on the latest guidelines and treatment options for chronic liver disease and cirrhosis. He mentions several online resources like GHAPP, AASLD, and EASL as key platforms he uses in his practice. He also mentions up-to-date clinical practice guidelines as a helpful tool, but acknowledges the difficulty of keeping up with the vast number of guidelines coming from different societies.

Both Jordan and Patrick agree that staying on top of rapidly changing guidelines can be overwhelming, but they stress the importance of continuing medical education to stay informed about the latest treatments, clinical trials, and medication updates. Patrick emphasizes that medical education platforms, including webcasts, podcasts, and in-person meetings, are valuable resources. Additionally, Jordan mentions that referencing specific medication manufacturers’ websites has been especially helpful in prescribing medications for patients, as they provide up-to-date, patient-friendly resources, such as package inserts and copay assistance information. This type of information is beneficial not only for healthcare providers but also for patients, who can access the resources independently.

One key topic the pair discusses is the emotional burden that patients with cirrhosis and their families face. Diagnosing a patient with cirrhosis can be overwhelming, both for the patient and their caregivers. The providers stress that cirrhosis is a chronic condition, and the journey of managing it can be long and difficult. They emphasize that patients may have to undergo multiple tests and frequent follow-ups. This can create a sense of emotional fatigue for both patients and their families, and it’s important for healthcare providers to understand and address this burden.

Patrick explains that education is a critical aspect of helping patients navigate their diagnosis. He mentions that it’s essential to reiterate important information during each visit, such as the need for liver cancer screening (HCC), monitoring signs of decompensation, and possibly the future need for a liver transplant. This type of education should be ongoing, even in between visits, to ensure the patient remains informed and empowered to take control of their health. Patrick also advises providers to stress that if a patient has any concerns, even if they’re unsure, it’s always better to reach out for clarification than to wait for problems to worsen.

In addition to supporting the patients themselves, Patrick highlights the importance of supporting caregivers, who often take on a large part of the responsibility in managing the care of a loved one with cirrhosis. Both providers agree that caregivers are often underappreciated and may also need resources and guidance. Jordan mentions that at UT Southwestern, there are fewer resources available for caregivers, but they do their best to provide emotional support and act as the primary source of care coordination. They both stress the importance of listening to patients and caregivers and offering resources when possible, especially for those without access to social workers or other support services.

The discussion also touches on the multidisciplinary nature of managing chronic liver disease and cirrhosis. Providers often work with other specialists to address the various complications that may arise, as cirrhosis is rarely the only medical issue a patient faces. Patrick notes that cirrhosis is often part of a complex array of health problems that require a comprehensive treatment approach. Both providers acknowledge the importance of collaborating with other healthcare professionals to provide well-rounded, holistic care.

Ultimately, this episode emphasizes that managing chronic liver disease and cirrhosis requires not only a deep understanding of medical guidelines and treatment options but also emotional and practical support for patients and their families. Healthcare providers must continuously educate themselves, revisit guidelines, and be open to using a variety of resources. More importantly, they need to recognize the emotional toll of the disease on patients and their caregivers and offer ongoing support and education. By doing so, providers can help patients manage their condition effectively and improve their quality of life.

For further information on managing liver disease, cirrhosis, and supporting both patients and caregivers, visit the GHAPP website and explore the range of educational resources and tools available for healthcare professionals.

Thank you to Johnson & Johnson for your support of this FAQ Video Module.

In this video module, Amy Stewart, NP, from Capital Digestive Care, in Washington, D.C., explores the potential correlation between CD64-expressing myeloid cells and endoscopic disease severity in patients with inflammatory bowel disease (IBD).

CD64 is a plasma membrane receptor found on myeloid cells, a category of blood cells originating from the bone marrow. Myeloid cells include monocytes, macrophages, granulocytes, and dendritic cells, all of which play an essential role in the innate immune response.

In IBD, these immune cells contribute to inflammation through the production of pro-inflammatory cytokines, such as IL-23 and IL-12, which are generated by mononuclear phagocytes. Research has identified CD64-positive myeloid cells as a primary source of IL-23 in inflamed gut tissues, particularly in patients with Crohn’s disease.

One study has demonstrated that in patients with Crohn’s disease, the Simple Endoscopic Score for Crohn’s Disease (SES-CD) was positively correlated with the presence of CD64-expressing cells. Additionally, CD64-positive cells accumulate in inflamed colonic tissues, and their proportion is directly associated with disease severity, regardless of treatment history, demographics, or disease classification.

Understanding the underlying pathogenesis of inflammatory bowel disease is crucial for treatment decision-making. The presence of CD64-positive myeloid cells as key players in IL-23-driven inflammation suggests that targeting these pathways could provide new therapeutic insights for managing moderate to severe IBD.

For more insights on emerging research in IBD, visit the GHAPP website for the latest updates on disease mechanisms, treatment options, and clinical guidelines.

In this insightful GHAPPcast podcast, Patrick Horne, a nurse practitioner at the University of Florida, joins Jordan Mayberry, a physician assistant at UT Southwestern, to discuss the diagnosis and management of cirrhosis. They explore the latest diagnostic techniques, the role of non-invasive testing, and strategies for monitoring and managing cirrhosis patients to ensure the best possible care.

When diagnosing cirrhosis, Jordan Mayberry emphasizes a multi-faceted approach that includes lab work, physical exams, and imaging. Essential diagnostic markers include liver enzyme tests to assess inflammation, albumin, bilirubin, and INR tests to evaluate liver function, and platelet counts, as thrombocytopenia is often an early indicator of cirrhosis. In addition to laboratory tests, a thorough physical exam is necessary to assess signs such as ascites, lower extremity edema, spider angiomata, and palmar erythema. Imaging techniques like ultrasound help detect liver nodularity and signs of portal hypertension, making early diagnosis possible.

As cirrhosis progresses, staging the disease becomes critical for determining treatment strategies. Non-invasive tests have become increasingly important in this process. These include FibroScan, an elastography tool that assesses liver stiffness, the FIB-4 score, a blood test used to evaluate fibrosis, and the ELF score, another serum marker for fibrosis assessment. For patients requiring more detailed evaluation, MR elastography (MRE) is a secondary option for staging liver fibrosis.

Although liver biopsy was once considered the gold standard for diagnosing cirrhosis, its role has diminished with the advancement of non-invasive testing. However, it remains essential when a diagnosis is unclear or when required for clinical trials and certain treatment plans.

Once a cirrhosis diagnosis is established, managing potential complications is crucial. Common complications include fluid overload (ascites), jaundice, esophageal varices, hepatic encephalopathy (HE), and hepatocellular carcinoma (HCC). Jordan stresses the importance of patient education to ensure early intervention. Patients should be informed about the risks of rapid weight gain due to fluid retention and be encouraged to seek medical attention if symptoms worsen. Screening for esophageal varices through endoscopy is essential, and patients at risk of HCC should undergo imaging and AFP testing every six months.

Ongoing care for cirrhosis patients requires regular monitoring and patient education. Jordan highlights the necessity of involving both patients and their families in the management process, teaching them to recognize early signs of complications such as fluid retention and gastrointestinal bleeding. By staying informed, patients can receive timely medical care and prevent severe health issues.

Lifestyle modifications also play a significant role in slowing the progression of cirrhosis. Patients should abstain from alcohol, particularly if their cirrhosis is alcohol-related. A healthy diet and exercise regimen are strongly recommended, with a focus on a Mediterranean-style diet and a combination of cardiovascular and resistance exercises. Interestingly, research suggests that caffeine consumption may have potential benefits in reducing liver inflammation. While not a universal recommendation, coffee drinkers may find reassurance in continuing their habit, as it could positively impact liver health.

For patients with specific liver conditions, such as autoimmune hepatitis or viral hepatitis, appropriate medical treatment should be initiated to manage their disease effectively. By using a combination of diagnostic tests, non-invasive tools, and proactive patient education, healthcare providers can ensure that cirrhosis patients receive optimal monitoring and care.

With regular screening, lifestyle modifications, and comprehensive medical support, patients with cirrhosis can achieve better health outcomes and an improved quality of life. For more information on cirrhosis diagnosis, treatment, and management, visit the GHAPP website or download the GHAPP ACE app.

This GHAPPcast podcast, supported by Johnson & Johnson, underscores the importance of ongoing medical education and advancements in patient care.

Thank you to Johnson & Johnson for your support of this FAQ Video Module.

Join Sarah Enslin, PA-C, from the University of Rochester Medical Center, as she explores the latest advancements in CD64-positive cell targeting and IL-23-directed therapy. This innovative approach enhances the specificity and effectiveness of treatment for psoriasis, psoriatic arthritis, and inflammatory bowel disease (IBD) by engaging immune cells responsible for chronic inflammation.

Learn how CD64, a high-affinity receptor on monocytes, macrophages, and dendritic cells, becomes upregulated during inflammation, making it a critical target for IL-23 inhibitors. Discover the role of monoclonal antibodies like GOMAB, which neutralize IL-23 while binding to CD64-expressing cells, optimizing treatment impact, reducing inflammation, and improving patient outcomes.

For more information on the latest research in rheumatology and immunology, visit the GHAPP website or download the GHAPP ACE app.