Expert Interviews

2 experts are featured in this series.

Panelists discuss how the GALAXI trials’ limitations include exclusion of patients with penetrating/stricturing disease and perianal fistulizing disease and pediatric populations, while emphasizing key takeaways for different stakeholders: Patients can expect strong symptomatic relief with endoscopic healing and excellent safety, providers gain a rigorously-tested first-line treatment option with evidence-based positioning in treatment algorithms and payers should recognize the high-value therapy with potential long-term cost savings through durable remission and reduced disease complications.

1 expert is featured in this series.

An expert discusses how underutilization of combination lipid-lowering therapies stems from overly complex guidelines, primary care providers managing multiple chronic diseases simultaneously, cost and insurance coverage concerns, unfamiliarity with newer medications, and systemic health care barriers. He notes that these issues are particularly problematic when 50% of patients who experienced a heart attack are not even receiving foundational statin therapy 6 months post event.

2 experts are featured in this series.

Panelists discuss how guselkumab demonstrated a very reassuring safety profile with no new safety signals or unexpected adverse events compared with placebo and consistent with safety data from other disease indications, requiring no different monitoring protocols than standard care for Crohn’s disease patients on advanced therapies, while emphasizing that uncontrolled disease itself represents the biggest safety concern.

2 experts are featured in this series.

Panelists discuss how the GALAXI trial results demonstrated guselkumab’s durability, efficacy, rapid onset and clean safety profile with superiority over ustekinumab across most objective end points, including endoscopic response and deep remission. The clinical and endoscopic end points align with STRIDE-2 treatment targets and translate to meaningful patient outcomes, including symptom resolution and reduced future hospitalizations, surgeries and disease flares.

1 expert is featured in this series.

An expert discusses how nonstatin therapies serve as essential tools when patients can’t tolerate statins or need additional LDL cholesterol-lowering agents. These include ezetimibe (a cholesterol absorption inhibitor), bempedoic acid (a liver-specific prodrug) and PCSK9-interfering therapies (both injectable monoclonal antibodies and inclisiran), with treatment selection based on patient comorbidities, cardiovascular risk level and specific LDL cholesterol targets.

An expert discusses how insurance coverage barriers for Janus kinase (JAK) inhibitors in vitiligo treatment can be overcome by demonstrating medical necessity, especially for visible areas such as the face and hands, while emphasizing the cultural and social stigma that makes treatment essential rather than cosmetic.

2 experts are featured in this series.

Panelists discuss how the GALAXI trials enrolled a broadly generalizable population of adults with moderate to severe Crohn’s disease (CDAI 220-450) requiring objective evidence of active inflammation, including both bio-naive and bio-experienced patients with approximately 40% to 50% having previously failed advanced therapies, although patients previously exposed to ustekinumab or other p19 inhibitors were excluded due to the active comparator design.

2 experts are featured in this series.

Panelists discuss how the GALAXI-2 and GALAXI-3 trials represented a landmark study design for Crohn’s disease research through their rigorous triple-dummy active comparator methodology, treat-through model without rerandomization, inclusion of both bio-naive and bio-experienced patients, composite primary end points measured at individual patient levels, and the unique ability to conduct pooled analyses comparing guselkumab directly with ustekinumab as an active comparator.