Video content above is prompted by the following:

Overview of Spesolimab for Management of GPP

Spesolimab, an IL-36R inhibitor, is now FDA-approved to treat GPP. Can you give a brief overview of spesolimab and the efficacy and safety evidence we have seen to date.
a.	EFFISAYIL-1—IV formulation (Bachelez, 2021)
b.	EFFISAYIL-2—SQ formulation (Morita, 2023)


Panelists provide an overview of spesolimab, an IL-36R inhibitor now FDA-approved for treating GPP, discussing the efficacy and safety data from the EFFISAYIL-1 trial (intravenous [IV] formulation) and the EFFISAYIL-2 trial (subcutaneous
[SQ] formulation).


Boni Elewski, MD, FAAD 

Measuring Patient Satisfaction with Inflammatory Bowel Disease Treatments and Communication Regarding Treatment Changes 

How do you evaluate patients’ satisfaction and expectations when providing care for UC and CD?

How do you discuss with patients the idea of escalating/switching therapy, perhaps in the absence of symptoms, and target something they may not feel?

Silvio Danese, MD, PhD; Bruce Sands, MD, and Jean-Frederic Colombel, MD, conclude by sharing their approaches to evaluating patient satisfaction and expectations when providing care for ulcerative colitis and Crohn's disease, while also touching upon the importance of discussing the potential need for escalating or switching therapies to better manage the underlying disease processes. 

Bruce Sands, MD 

Atrial fibrillation (AF) is linked to an increase in embolic strokes and thus most patients with AF will be prescribed anticoagulants to decrease this incidence.

AF is frequent in chronic kidney disease (CKD) with estimates ranging from 16-21% in non-dialysis patient and up to 40% in dialysis patients.1 AF is associated with both worse cardiac and kidney outcomes with an increased risk of CKD progression.

 The incidence of stroke in End Stage Kidney Disease (ESRD) is 7-9 times greater than in the general population and 3-fold more deadly.

For many years, warfarin was the drug of choice to decrease strokes in all populations but serum monitoring requirements, diet restrictions and narrow therapeutic window led to multiple complications. With the introduction of the direct oral anticoagulant (DOACs) medications, the complication rate in AF was significantly decreased.

As is true for most drug trials, patients with severe CKD (defined as an eGFR 

25 ml/min) were excluded from the DOAC trials.

 This is not unexpected; kidney patients have multiple comorbidities and are treated with multiple medications.

These comorbidities and medications add a level of complexity to the evaluation of adverse events during a drug trial. Yet, for a population where close to half of the population has AF, we do not have answers about the use of DOACs.

As there is no guidance from the pivotal DOAC trials for the CKD and ESRD patients, the kidney community has undertaken the collection of data from real world use of DOACs. We know that acute kidney injury (AKI) is significantly lower with the use of DOACs vs warfarin.

This is true for all stages of CKD, even in the elderly.

Using a meta-analysis approach, we have seen that DOACs have a better safety and effectiveness profile than warfarin.

 For this reason, the Kidney Disease Improving Global Outcomes (KDIGO) expert workgroup has developed recommendations for use of DOACs in CKD.

Yet, there is still a population that KDIGO recommendations did not address: the ESRD patient.

In the kidney failure patient, the incidence of AF is 40% and the stroke and sudden cardiac death are common.

 While cardiology defers to nephrology when treating ESRD, nephrology is divided on optimal treatment for this population. Most trials are retrospective and observational. However, recently randomized, controlled trials have been conducted.

With the most recent trial data available, the consensus is that warfarin is the most dangerous for this population whether it is used for AF prophylaxis or treatment for recurrent thromboembolism.

 Warfarin increases the incidence of bleeding without decreasing mortality. Two other large trials looking at DOAC vs warfarin both showed a better safety profile for apixaban but there were significant episodes of bleeding in the dialysis population.

 For this reason, the recently closed preliminary trial of three separate trial arms, which examine apixaban, warfarin, and no treatment, respectively, is being closely watched.

This Canadian/Australian trial included 151 participants and is a pilot to evaluate if we should 

 be treating the dialysis population with anticoagulants. The trial was completed in late December 2022. Results are pending.

If, as expected, the no treatment arm has a similar outcome profile with less bleeding complications, we will have to reassess our mantra of 

 while we stop treating the AF patient on dialysis with anticoagulants. A definite relearn for all of us.

Wanner C, Herzog CA, Turakhia MP; Conference Steering Committee. Chronic kidney disease and arrhythmias: highlights from a Kidney Disease: Improving Global Outcomes (KDIGO) Controversies Conference. 

Bobot M, Suissa L, Hak JF, et al. Kidney disease and stroke: epidemiology and potential mechanisms of susceptibility. 

Garlo KG, Steele DJR, Nigwekar SU, et al. Demystifying the Benefits and Harms of Anticoagulation for Atrial Fibrillation in Chronic Kidney Disease. 

Harel Z, McArthur E, Jeyakumar N, et al. The Risk of Acute Kidney Injury with Oral Anticoagulants in Elderly Adults with Atrial Fibrillation. 

Malhotra K, Ishfaq MF, Goyal N, et al. Oral anticoagulation in patients with chronic kidney disease: A systematic review and meta-analysis. 

Wetmore JB, Herzog CA, Yan H, et al. Apixaban versus Warfarin for Treatment of Venous Thromboembolism in Patients Receiving Long-Term Dialysis. 

Mavrakanas TA. Should Oral Anticoagulation Be Used in ESKD Patients on Hemodialysis with Atrial Fibrillation?: COMMENTARY. 

Pokorney SD, Chertow GM, Al-Khalidi HR, et al for the RENAL-AF Investigators. Apixaban for Patients With Atrial Fibrillation on Hemodialysis: A Multicenter Randomized Controlled Trial. 

Reinecke H, Engelbertz C, Bauersachs R, et al. A Randomized Controlled Trial Comparing Apixaban With the Vitamin K Antagonist Phenprocoumon in Patients on Chronic Hemodialysis: The AXADIA-AFNET 8 Study. 

Strategies for the management of atrial fibrillation in patients receiving dialysis (Safe-D) ClinicalTrials.gov identifier NCT03987711

Kim Zuber, PA-C, and Jane Davis, DNP, offer insight into the use of DOACs in people with atrial fibrillation and chronic kidney disease. 

Using DOACs in People with Chronic Kidney Disease, with Kim Zuber, PA-C, and Jane Davis, DNP

Debra Davis, CRNP

Gerald Appel, MD, is a professor of clinical medicine, director of clinical nephrology, and director of the Glomerular Disease Center at Columbia University.

 has been a disease without a targeted treatment, leaving patients and clinicians to deal with a devastating disease course with no clear standard of care.

Caused by dysregulation of the alternative complement pathway, C3G often leads to progressive kidney failure, with many patients ultimately requiring transplantation—only to see the disease recur.

The US Food and Drug Administration approval of Novartis’ oral iptacopan (Fabhalta) for the treatment of adults with C3 glomerulopathy (C3G) marks a turning point in C3G care, offering the first FDA-approved drug for patients with the ultra-rare kidney disease.

The decision was based on data from the phase 3 APPEAR-C3G trial, where iptacopan met the primary endpoint of reducing 24-hour urine protein-to-creatinine ratio (UPCR) by 35.1% (95% CI, 13.8% to 51.1%; 

 = .0014), with sustained reductions at 12 months.

Additional analyses revealed use of iptacopan was associated with a higher proportion of patients meeting the composite renal endpoint—defined as a ≥50% UPCR reduction and ≤15% eGFR decline—occurring in 43.5% of iptacopan-treated patients versus 25.0% of those who switched from placebo at 6 months. A favorable effect on eGFR trajectory was also observed relative to historical trends.

Not only does this approval provide C3G patients with a treatment specifically designed to address the root cause of their disease, but it also opens the door for further advancements in complement-targeted therapies. With a new tool in their arsenal, clinicians can now offer patients a chance to slow or even stop disease progression—something that was once out of reach.

For additional insight into the significance of the approval and its impact on C3G care, the editorial team of 

 spoke with Gerald Appel, MD, a professor of clinical medicine, director of clinical nephrology, and director of the Glomerular Disease Center at Columbia University; Andrew Bomback, MD, an assistant professor of medicine at Columbia University Medical Center; and Jared Hassler, MD, a pathologist at the Temple University Hospital.

Expert Perspectives: Iptacopan FDA Approval for C3 Glomerulopathy

Relevant disclosures for Appel include Aurinia, Bristol Myers Squibb, Genentech, Genzyme-Sanofi, Eli Lilly, Merck, Pfizer, Mallinckrodt, Achillion, Alexion, Reata, Travere Therapeutics, GlaxoSmithKline, Vertex Therapeutics, Novartis, Apellis, Chinook, Arrowhead, Calliditas, and Vera. Relevant disclosures for Bomback include Amgen, Novartis, Kezar, Silence Therapeutics, Genentech, Visterra, Catalyst, Q32, and Apellis. Relevant disclosures for Hassler include Travere Therapeutics, Omeros, and Novartis.

Campbell P. FDA Approves Oral Iptacopan (Fabhalta) as First C3 Glomerulopathy Therapy. HCPLive. March 20, 2025. Accessed March 21, 2025. 

https://www.hcplive.com/view/fda-approves-oral-iptacopan-fabhalta-as-first-c3-glomerulopathy-therapy

A trio of nephrology experts discuss the significance of iptacopan’s FDA approval as the first treatment for C3G.

Gerald Appel, MD

LB-102 Significantly Improves Disease Severity in Acute Schizophrenia, with John Kane, MD

LB Pharmaceuticals announced additional positive data from NOVA, a phase 2 study evaluating LB-102 in acute 

, at the 2025 Annual Congress of the Schizophrenia International Research Society held in Chicago from March 29 to April 2.

 LB-102 provided significant improvement in disease severity, as demonstrated by the mean change from baseline in Clinical Global Impression of Severity (CGI-S) scores.

At week 4, participants on 50 mg of LB-102 (n = 107) achieved a mean change in baseline CGI-S score of -0.72 compared with placebo (

= .0008). For LB-102 doses 75 mg (n = 108) and 100 mg (n = 36), participants achieved a mean change in CGI-S from baseline of -0.67 (

This announcement followed the company’s

on January 8, 2025, stating that NOVA met its primary endpoint, with LB-102 significantly reducing the Positive and Negative Syndrome Scale (PANSS) total scores over 4 weeks in adults with acute schizophrenia compared to placebo.

Already, LB-102, a once-daily oral benzamide antipsychotic targeting both positive and negative symptoms, was evaluated in NOVA, a double-blind, placebo-controlled, multicenter trial with 359 adults aged 18 – 55 years who had a DSM-5 diagnosis of acutely exacerbated schizophrenia. NOVA’s primary endpoint was the change from baseline in the PANSS total score at day 28, and secondary endpoints included improvements in CGI, PANSS subscales, Marder Factor scores, safety and tolerability, and pharmacokinetics. Participants were randomized 3:3:3:1 to receive placebo or LB-102 at daily doses of 50 mg, 75 mg, or 100 mg for 4 weeks.

 recently spoke with lead investigator John M. Kane, MD, professor of psychiatry and molecular medicine at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, about the new data on improved CGI-S scores.

“This is another perspective that helps clinicians evaluate the efficacy of a medication, and the PANSS total score reflects results on specific items, and the CGI is really a measure of overall severity,” Kane explained. “And so, we see patients moving from one level of severity to a lower level…That's a very good clinical indicator.”

During the interview, Kane provided insight into the tolerability of LB-102 compared to 6 existing psychotics in terms of prolactin levels, weight gain, and extrapyramidal symptoms. Some patients on LB-102 experienced increased prolactin levels, but despite this, very few led to breast enlargement or erectile dysfunction. Very few patients experienced extrapyramidal symptoms, and while some experienced weight gain, it was not a lot.

When asked in what scenarios Kane might recommend LB-102 over current first—or second-line agents, he said it depends on trial results. LB-102 had already been successful as a first-line agent in trial participants.

People can also try LB-102 if they do not respond to other drugs. There are no current medications to treat negative symptoms of schizophrenia, so research may find LB-102 could manage these symptoms.

“We're also thinking about the maintenance effects, what are the characteristics of this medication over time, in terms of patient improvement, acceptability, and continuation,” Kane said. “…to me, that's really important. Most patients will be candidates to continue an antipsychotic medication for long periods of time, and how the drug performs over time is going to be very important. From what we've seen with amisulpride…the possibilities for LB-102 are very encouraging.”

Relevant disclosures for Kane include Otsuka Pharmaceuticals, Sumitomo Pharmaceuticals, H. Lundbeck, Teva Pharmaceuticals, Alkermes, and Boehringer Ingelheim, among others.

LB Pharmaceuticals Presents New Data from Phase 2 Clinical Trial of LB-102 at the 2025 Annual Congress of the Schizophrenia International Research Society. GlobeNewswire. March 31, 2025. 

https://www.globenewswire.com/news-release/2025/03/31/3052289/0/en/LB-Pharmaceuticals-Presents-New-Data-from-Phase-2-Clinical-Trial-of-LB-102-at-the-2025-Annual-Congress-of-the-Schizophrenia-International-Research-Society.html

Derman, C. Phase 2 LB-102 Data, Advancing Treatment Landscape in Schizophrenia, with John Kane, MD. HCPLive. January 10, 2025. 

https://www.hcplive.com/view/phase-2-lb-102-data-advancing-treatment-landscape-in-schizophrenia-with-john-kane-md

HCPLive spoke with Kane about new phase 2 data showing that an oral benzamide provides a significant change from baseline in CGI-S scores for participants with acute schizophrenia.


John Kane, MD

Lauren Blieden, MD, is a professor of ophthalmology at Baylor College of Medicine.

Long-Term Considerations in Angle Closure Glaucoma with Lauren Blieden, MD

 research evolves, long-term patient outcomes remain a key focus, particularly in angle closure cases. With critical gaps in long-term data, clinicians are refining management strategies while awaiting further research to guide best practices.

, Lauren Blieden, MD, a professor of ophthalmology at Baylor College of Medicine, highlighted critical updates in patient management, the role of patient education, and the importance of advocacy in ophthalmology. Blieden presented a talk entitled "Glaucoma/Narrow Angles” at the 

Texas Ophthalmological Association (TOA) Annual Meeting

Long-term follow-up data from the EAGLE trial remains a key area of interest in glaucoma research, particularly regarding the progression of angle closure as patients age. With nearly a decade since its publication, ophthalmologists are eager for updates to guide long-term management strategies. Blieden shared insights from her clinical experience, noting that while stable patients can often be monitored less frequently, uncertainties remain about disease progression in older age groups.

Blieden emphasized the importance of patient education, especially in diverse populations with a higher prevalence of angle closure. Early symptom recognition—such as sudden headaches or vision changes—can prevent delays in care. She also highlighted the need for patient awareness regarding medication-related risks and the importance of seeking specialized ophthalmic care rather than general emergency services in acute cases.

Blieden noted the Texas Ophthalmological Association (TOA), recently renamed the Texas Society of Eye Physicians and Surgeons, continues to serve as a vital platform for both clinical education and ophthalmic advocacy. Smaller meetings facilitate in-depth discussions on emerging research, case studies, and legislative issues, including scope-of-practice regulations and liability concerns.

Blieden LS. Glaucoma/Narrow Angles. Presented at Texas Ophthalmological Association (TOA) Annual Meeting. Houston, Texas. March 21-22, 2025

Blieden discusses long-term patient management in glaucoma, the importance of follow-up care, and the role of advocacy in ophthalmology.

Lauren Blieden, MD

Maliha Ahmed, DO

Muthiah Vaduganathan, MD, MPH, is a cardiologist specializing in cardiorenal metabolism at Brigham and Women's Hospital in Boston, MA. Vaduganathan is a member of Practical Cardiology's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Don't Miss a Beat: Treatment Sequencing in New Era of Heart Failure Management 

American College of Cardiology (ACC) 2025 Annual Scientific Sessions

 with preserved ejection fraction (HFpEF) treatment, focusing on the implementation of combination therapies. Hosts Steve Greene, MD, and Muthiah Vaduganathan, MD, MPH, discuss the transition from a previously limited treatment landscape to a new era with multiple proven therapeutic options.

To open the episode, Greene argues in favor of rapid-sequence implementation of HFpEF therapies, drawing parallels to the established 4-pillar guideline-directed medical therapy (GDMT) for heart failure with reduced ejection fraction (HFrEF). He highlights 3 key classes of medications—SGLT2 inhibitors, non-steroidal mineralocorticoid receptor antagonists (MRAs), and incretin-based therapies—as the foundation of HFpEF treatment. He emphasizes the importance of early and aggressive therapy initiation to maximize clinical benefits and reduce the risk of delayed or missed treatment opportunities among this population.

Vaduganathan acknowledges the strength of the data supporting combination therapy but suggests a more risk-based approach, considering the broad clinical variability among HFpEF patients. He advocates for prioritizing rapid implementation in high-risk patients, such as those recently hospitalized, while allowing a more measured approach for lower-risk individuals. The discussion also touches on the role of phenotyping in tailoring treatment decisions, with GLP-1 receptor agonists being particularly relevant for patients with obesity and ARNi potentially benefiting those with mildly reduced ejection fraction.

Looking ahead, the hosts preview upcoming trials, including CONFIDENCE and CONFIRMATION, which will evaluate combination therapy strategies in chronic kidney disease and HFpEF populations. They also discuss the potential of fixed-dose combination therapies to simplify implementation and improve adherence. The episode closes with both experts agreeing on the need for a structured, evidence-based approach to HFpEF treatment while emphasizing the importance of translating trial data into real-world practice. 

 include Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, Lexicon, and others. Relevant disclosures for 

 include Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others.

Heidenreich PA, Bozkurt B, Aguilar D, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. 

Patel R, Wadid M, Makwana B, et al. GLP-1 Receptor Agonists Among Patients With Overweight or Obesity, Diabetes, and HFpEF on SGLT2 Inhibitors. 

Hosts discuss how recent advances in HFpEF have changed discussions surrounding how cardiologists should approach treatment sequencing. 

Muthiah Vaduganathan, MD, MPH

The panelists stress the significance of a comprehensive approach to patient care.

Cardiometabolic Medicine: Seeing the Patient as a Whole

The panelists stress the significance of a comprehensive approach to patient care, acknowledging the interconnected nature of cardiovascular, kidney, endocrine, and obesity-related benefits, and highlighting that addressing secondary diseases can minimize overall disease risk in patients.

Pam Taub, MD, FACC, FASPC

Colorectal cancer is the third most common cancer and a leading cause of cancer death in the United States. Colonoscopy, recommended for all adults aged 45 or older, is a crucial screening tool where gastroenterologists remove polyps to prevent them from becoming cancerous. Recognizing the importance of detecting these polyps, the FDA authorized the first AI-assisted device for colonoscopies in 2021.

Dr. Gyanprakash Ketwaroo at the West Haven VA emphasizes the value of AI in providing a "second set of eyes" during colonoscopies. This technology, known as computer-aided detection (CADe), has shown promise in increasing adenoma detection rates, according to a meta-analysis led by Dr. Dennis Shung. The analysis, which reviewed 44 studies, found that CADe systems improved adenoma detection compared to standard colonoscopies, although the increase in advanced colorectal neoplasia detection was slight.

Shung's meta-analysis suggests further research is needed to assess AI's impact on interval colorectal cancer rates and recommends that future studies should randomize colonoscopists to understand better where CADe can be most effective. Yale has implemented this AI technology at the West Haven VA campus, providing additional support for endoscopists and trainees during procedures.

The American Gastroenterological Association (AGA) is also preparing new clinical guidelines for using AI in colonoscopies, for which Dr. Shung is the co-first author. These draft guidelines conditionally recommend CADe for polyp detection in adults, considering the technology's safety and efficiency. The AGA is gathering feedback from both providers and patients on AI use in screening, aiming to publish the final guideline in March 2025, with regular updates as the technology evolves.

Overall, AI-assisted colonoscopies represent a significant advancement in colorectal cancer screening, with the potential to enhance detection rates and outcomes for patients. Clinicians are advised to stay informed on evolving guidelines and technological developments to offer the best care possible.

Colorectal cancer ranks as the third most prevalent cancer and a major cause of cancer mortality in the U.S. Colonoscopy is vital for early detection, with AI-assisted devices enhancing polyp detection. The FDA approved the first AI device for colonoscopies in 2021, and studies show improved adenoma detection rates with AI. Further research is needed to evaluate AI's impact on interval cancer rates. The American Gastroenterological Association is developing guidelines for AI use in colonoscopies, with final recommendations expected in March 2025, emphasizing the importance of staying updated on advancements.

Computer-aided detection during colonoscopies with AI may help increase adenoma detection rates.

Authors