Skin Clearance and Psoriasis Improvements from Bimekizumab, With Ron Vender, MD

, Ronald Vender, MD, focused on how clinicians should interpret the relationship between objective skin clearance and patient-reported quality of life, emphasizing that the connection is not always as straightforward as it may seem.

Vender noted while dermatologists often expect that clear skin will automatically translate into a low Dermatology Life Quality Index (DLQI) score, such a correlation is not guaranteed. The DLQI is designed to capture specific aspects of how psoriasis impacts daily life. Factors such as pain in joints, treatment burden, or other symptoms may impact quality of life independently of visible plaque clearance. Similarly, relief of skin pain, pruritus, and scaling, while very important, does not always perfectly align with improvements in patient-reported well-being.

Vender noted the BE RADIANT data help to clarify this connection. Over 3 years, individuals treated with bimekizumab not only attained high rates of complete skin clearance but also maintained persistently low DLQI scores. For Vender, this concurrent durability of clinical and patient-reported outcomes helps to reinforce the notion effective biologic use can meaningfully impact how patients live with psoriasis.

Zooming out to the long-term data, Vender highlighted the reassurance provided by sustained efficacy over 3 years. As a dermatologist prescribing biologics, he said the durability of both skin clearance and quality-of-life improvements allows him to counsel patients with a greater level of confidence about long-term expectations. He also noted the medication’s low dropout rate across endpoints, describing persistence of benefit as not undermined by high discontinuation.

Regarding treatment sequencing, Vender acknowledged that secukinumab remains highly effective for many patients. However, those who switched to bimekizumab demonstrated further improvements, suggesting incremental gains in patients’ levels of symptom control and quality of life may be attainable in certain cases.

Looking ahead, Vender expressed interest in longer-term follow-up beyond 3 years and real-world evidence comparisons to reinforce trial findings. Ultimately, Vender concluded patient-reported outcomes continue to be essential in evaluating medication success, as durable symptom relief and improved daily functioning are central goals in care for psoriasis.

The quotes used in this video summary were edited for clarity.

Vender has reported support from AbbVie, Alumis, Amgen, Arcutis, Bausch, Bristol Myers Squibb, Celltrion, JAMP, Janssen, Leo, Lilly, Meiji, Novartis, Organon, Orka, Sandoz, Sun, Takeda, and UCB.

Augustin M, Feldman SR, Warren RB, et al. Three-Year Patient-Reported Outcomes From Bimekizumab for Plaque Psoriasis: The BE RADIANT Randomized Clinical Trial With Open-Label Extension. JAMA Dermatol. Published online February 18, 2026. 

Smith T. BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use. HCPLive. February 19, 2026. Accessed February 22, 2026. 

https://www.hcplive.com/view/be-radiant-trial-bimekizumab-effective-psoriasis-after-3-years-use

Videos

This interview segment highlights additional points on bimekizumab and psoriasis related to patient-reported outcomes (PROs) in the 3 year BE RADIANT study.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Implantable Insulin Pumps and Interoperability

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, explore advances in implantable diabetes technologies, focusing on a novel implantable insulin pump from Portal Diabetes that has received FDA Breakthrough Device designation.

00:03:41 What makes it different from MiniMed?

The hosts begin by clarifying that breakthrough status is granted to technologies with the potential to substantially improve care, allowing for more streamlined clinical development and regulatory interaction. They contextualize the innovation historically, referencing earlier implantable pump systems developed by MiniMed, now part of Medtronic. Although those systems were used in the United States and remain available in limited European markets, they were ultimately eclipsed by the convenience and lower cost of subcutaneous pump platforms.

The Portal system differs fundamentally from traditional subcutaneous insulin pumps. Surgically implanted in the abdomen, the device delivers insulin intraperitoneally, allowing rapid absorption into the portal circulation. The hosts emphasize the physiologic implications of this route: markedly faster onset and offset of insulin action, elimination of pre-meal bolusing, and potentially improved safety around exercise due to shorter insulin tail effects. Such pharmacokinetic advantages may better approximate endogenous insulin secretion compared with subcutaneous delivery.

A distinguishing feature of the new platform is its aim to achieve fully automated, closed-loop insulin delivery through integration with continuous glucose monitoring (CGM). Unlike current hybrid closed-loop systems, which still require meal announcements and manual bolusing, the envisioned system would respond dynamically to rising glucose levels without user input, significantly reducing cognitive and behavioral burden for people with diabetes.

The discussion also addresses critical technical and practical considerations. The company is reportedly developing a proprietary temperature-stable concentrated insulin formulation, potentially exceeding U-500 strength, to maximize reservoir longevity. Refill intervals are projected at six to twelve weeks via a minimally invasive in-office percutaneous procedure, avoiding explantation. However, questions remain regarding device miniaturization, durability, infection risk, insulin stability, precision micro-dosing with highly concentrated formulations, and long-term cost-effectiveness. As the hosts note, payer acceptance will be essential for market viability, particularly given historical cost barriers associated with implantable systems.

In addition, the episode highlights the first commercial interoperability between the implantable Eversense 365 CGM and the Twiist insulin pump. The year-long implantable sensor reduces insertion frequency, mitigates compression artifacts, and may benefit individuals with dermatologic sensitivity to transcutaneous sensors. Although initial weekly calibrations are required, these decrease over time. With pump connectivity now available, the hosts anticipate expanded adoption among patients seeking lower-maintenance CGM options.

Overall, the conversation conveys measured optimism. While both technologies remain early in adoption and face clinical, regulatory, and economic hurdles, they represent meaningful progress toward physiologic insulin replacement, reduced therapeutic burden, and expanded personalization in advanced diabetes care.

Editor’s Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Podcasts

Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the Portal implanted insulin pump, which has received Breakthrough Device designation from the FDA.

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include phase 3 data for obinutuzumab in primary membranous nephropathy as well as ixekizumab and tirzepatide in moderate-to-severe plaque psoriasis and obesity or overweight with ≥ 1 additional weight-related comorbid condition, new data supporting the cardiovascular benefits of AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted), findings from a second phase 3 trial evaluating COMP360 in treatment-resistant depression, and preclinical data for Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of February 15, 2026—let’s jump in!

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

On February 16, 2026, Genentech, a member of the Roche Group, announced that the phase 3 MAJESTY study in adults with primary membranous nephropathy met its primary endpoint, showing statistically significant and clinically meaningful results with obinutuzumab (Gazyva).

In the study, significantly more people achieved complete remission at 2 years (104 weeks) with obinutuzumab versus tacrolimus, with no new safety signals identified. Genentech described plans to present the data at an upcoming medical meeting and share it with health authorities, including the US Food and Drug Administration.

Ixekizumab, Tirzepatide Effective Together for Psoriasis and Obesity or Overweight

On February 19, 2026, Eli Lilly and Company announced positive topline results from the landmark TOGETHER-PsO open-label phase 3b clinical trial evaluating the concomitant use of ixekizumab (Taltz) and tirzepatide (Zepbound) compared to ixekizumab alone in adults with moderate-to-severe plaque psoriasis and obesity or overweight with ≥ 1 additional weight-related comorbid condition.

Results showed that at 36 weeks, treatment with ixekizumab and tirzepatide met the primary and all key secondary endpoints, delivering superior skin clearance and weight loss versus ixekizumab monotherapy.

AREXVY Vaccine Reduces Hospitalization, Major Adverse Cardiovascular Events in RSV

On February 18, 2026, GSK announced new effectiveness data for AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy.

This retrospective cohort study included >2.5 million patients, of whom 520,440 were vaccinated and matched in a 1:4 ratio to 2,081,760 patients who did not receive the vaccine. Results showed the vaccine was associated with 75.6% effectiveness against RSV-related hospitalization at a median follow-up period of 5.6 months post-vaccination. Additional exploratory endpoints indicated 63.1% vaccine effectiveness against major adverse cardiovascular events, including heart attack and stroke, during hospitalization among patients aged ≥60 years.

COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD

On February 17, 2026, Compass Pathways announced that its investigational synthetic psilocybin formulation, COMP360, met the primary endpoint in the second pivotal phase 3 trial evaluating the therapy in adults with treatment-resistant depression.

In the COMP006 study, a pair of 25-mg doses administered 3 weeks apart produced a statistically significant reduction in depressive symptom severity at week 6 compared with a 1-mg dose control, reinforcing findings from the companion COMP005 trial and advancing the program toward regulatory submission.

Thykamine Shows Disease-Modifying Potential in MASH Using Liver-on-a-Chip Platform

On February 19, 2026, Devonian Health Group announced positive results from a follow-up preclinical study evaluating Thykamine™ in a human metabolic-associated steatohepatitis (MASH) model using PhysioMimix® Liver-on-a-Chip platform. The study was conducted by CN Bio Innovations, Cambridge, UK. The study demonstrates that Thykamine™ exerts dose-dependent effects on key pathological hallmarks of MASH, including fibrosis and inflammation, in a physiologically relevant human liver system, representing a notable translational bridge between Devonian’s previously disclosed efficacy in the mouse STAM® MASH model and a predictive human microphysiological model.

Articles

Phase 3 MAJESTY data showed obinutuzumab achieved higher 104-week complete remission rates than tacrolimus in primary membranous nephropathy, without new safety signals, supporting regulatory engagement. In TOGETHER-PsO, concomitant ixekizumab plus tirzepatide outperformed ixekizumab alone for skin clearance and weight loss in patients with plaque psoriasis and obesity/overweight with comorbidities. Real-world effectiveness data linked AREXVY to fewer RSV hospitalizations and exploratory reductions in in-hospital MACE. COMP360 synthetic psilocybin met a second pivotal TRD endpoint. Thykamine demonstrated dose-dependent anti-fibrotic and anti-inflammatory effects in a human Liver-on-a-Chip MASH model.

The HCPFive: Top News for Healthcare Providers from the Week of 02/15

Mark Creager, MD, FACC | Image Credit: Dartmouth Health

On February 19, 2026, the American Heart Association (AHA) and the American College of Cardiology (ACC) released the first clinical practice guidelines on the treatment of 

, detailing risk factors and recommending treatment and follow-up after diagnosis.

“There have been significant advances in the understanding of pulmonary embolism and treatments to effectively manage this condition,” Mark Creager, MD, FACC, professor of medicine at the Geisel School of Medicine at Dartmouth College, director emeritus of the Heart and Vascular Center at Dartmouth Health, and chair of the guideline writing committee, said in a statement. “This guideline is a road map to help clinicians navigate these advances for the safest and most effective approaches to care for people with this condition.”

The guidelines’ key takeaways, as listed by the investigator committee, are as follows:

Patients with acute PE who are asymptomatic can be safely discharged home. Early hospital discharge is also recommended for patients with acute PE who are symptomatic but have a low clinical severity score.

Symptomatic patients with acute PE and an elevated clinical severity score should be hospitalized to optimize treatment strategies. This includes those with elevated biomarkers and/or right ventricular dysfunction, cardiopulmonary failure with persistent hypotension, and incipient cardiopulmonary failure.

Low-molecular-weight heparin (LMWH) is recommended rather than unfractionated heparin (UFH) in patients with acute PE who need initial parental anticoagulant therapy.

Patients with acute PE eligible for oral anticoagulation should be given direct oral anticoagulants (DOACs) over vitamin K antagonists, unless contraindicated. These will prevent recurrent 

Patients with a first acute PE without a major reversible factor or with a persistent risk factor, continuing anticoagulation beyond the initial treatment phase of 3-6 months is recommended.

Patients with acute PE in AHA/ACC PE Category E1 should receive advanced therapies like systemic thrombolysis, catheter-based thrombolysis, mechanical thrombectomy, and surgical embolectomy. These treatments should also be considered for patients in AHA/ACC PE Category D1-2.

Patients who have had acute PE should regularly be asked about related symptoms and functional limitations at every clinic visit for ≥1 year to screen for causes of dyspnea and functional limitation like chronic thromboembolic pulmonary disease (CTEPD).

Additionally, the team highlighted factors that damage the veins or reduce blood flow, promoting the likelihood of clot formation and thereby increasing the risk of venous thromboembolism. These include prolonged immobility, pregnancy and postpartum within 6 weeks of delivery, use of oral contraceptives or estrogen treatment, obesity, smoking, atherosclerotic cardiovascular disease, and cancer, among others.

Patients with low or intermediate probability of acute PE based on symptom analysis should undergo a blood test for the measurement of D-dimer – elevated levels of this protein can signal the need for imaging to look for signs of a PE. The guidelines recommend computed tomography pulmonary angiography (CTPA) given its high accuracy and availability. For patients incapable of undergoing CTPA, the guidelines recommend screening via a lung ventilation/perfusion scan.

Additionally, the guidelines highlight the need for follow-up after treatment, including both physical and psychological aspects of care. The authors note depression, anxiety, and post-traumatic stress disorder as common in patients who have experienced acute PE. Physical activity and limiting long-distance travel are also encouraged to minimize the risk of further clotting.

“We anticipate that decisions guided by these recommendations will result in more rapid diagnosis and application of effective, evidence-based treatments, leading to better outcomes, such as decreased risk of death and disability, for people with acute pulmonary embolism,” Creager said.

American Heart Association. First AHA/ACC acute pulmonary embolism guideline: prompt diagnosis and treatment are key. 

. February 19, 2026. Accessed February 20, 2026. 

https://www.eurekalert.org/news-releases/1116906

Creager MA, Barnes GD, Giri J, et al. 2026 AHA/ACC/ACCP/ACEP/chest/SCAI/SHM/SIR/SVM/SVN guideline for the evaluation and management of Acute Pulmonary embolism in adults: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. Published online February 19, 2026. 

New AHA/ACC guidelines outline contemporary evaluation, risk stratification, treatment, and longitudinal care for acute pulmonary embolism. Disposition is guided by symptom burden and clinical severity, enabling safe outpatient management for low-risk patients while prioritizing hospitalization for higher-risk phenotypes with RV dysfunction, biomarker elevation, or evolving cardiopulmonary failure. Anticoagulation recommendations favor LMWH for initial parenteral therapy and DOACs for eligible patients, with extended therapy for unprovoked or persistent-risk PE. Diagnostic pathways emphasize D-dimer triage and CTPA, plus structured follow-up for CTEPD and mental health sequelae.

The new joint guidelines include a clinical classification system, major contributing factors, and recommendations for treatment and follow-up.

AHA and ACC Release First Guideline for Pulmonary Embolism Treatment

Interpreting 3-Year Data on Bimekizumab from BE RADIANT, With Ron Vender, MD

In the phase 3b BE RADIANT trial comparing bimekizumab with secukinumab in moderate to severe 

, investigators assessed not only traditional efficacy endpoints but also patient-reported outcomes (PROs) over 3 years. In discussing the results with 

, Ronald Vender, MD, suggests PROs are among the most meaningful measures for the assessment of chronic inflammatory diseases.

, one of the most striking observations was the rapid onset of symptom relief with bimekizumab. After only 1 dose, by Week 4, subjects reported absence of pruritus, skin pain, and scaling at higher rates than those treated with secukinumab therapy. In parallel, some subjects attained complete skin clearance (PASI 0) and a Dermatology Life Quality Index (DLQI) score of 0 or 1, suggesting a minimal impact of disease on quality of life. For Vender, that early combination of objective clearance and subjective symptom resolution points to the clinical importance of rapid psoriasis control.

At 1 year, symptom resolution remained more frequent with bimekizumab, and Vender highlighted that the durability of response through year 3 is particularly reassuring. He noted clinicians often worry about waning biologic efficacy over the course of time. However, sustained lack of itch, pain, and scaling, coupled with maintained low DLQI scores and continued PASI 0 responses, suggests durable benefit. Importantly, he cautioned that clear skin does not always automatically translate to a low DLQI, making the concurrent achievement of both endpoints clinically meaningful.

When asked about long-term interpretation, Vender described the 3-year efficacy data as providing confidence in continued skin clearance and sustained quality-of-life improvements. He framed these results as supportive of ongoing utilization in appropriate patients, allowing clinicians to reassure those for whom the benefits can persist.

Finally, regarding a question on treatment sequencing, Vender described patients who shifted from secukinumab to bimekizumab as having experienced further improvements in symptom control and clearance. While acknowledging secukinumab remains an effective medication, he suggested the switching data suggest additional gains in PROs may be attainable with dual IL-17A/F inhibition in select individuals.

The quotes included in this summary were edited for clarity.

Vender reported support from AbbVie, Alumis, Amgen, Arcutis, Bausch, Bristol Myers Squibb, Celltrion, JAMP, Janssen, Leo, Lilly, Meiji, Novartis, Organon, Orka, Sandoz, Sun, Takeda, and UCB.

Smith T. BE RADIANT Trial: Bimekizumab Effective for Psoriasis After 3 Years of Use. HCPLive. February 19, 2026. Accessed February 20, 2026. 

In this segment of his interview, Vender highlighted his own views on the significance of BE RADIANT trial findings on bimekizumab for psoriasis.

COMP360 Psilocybin Shows Rapid, Durable Effect in TRD, With Steve Levine, MD

Following positive topline results from the phase 3 COMP006 trial, 

 spoke with Steve Levine, MD, chief patient officer of Compass Pathways, to contextualize the clinical relevance of COMP360 (synthetic psilocybin) for treatment-resistant 

“One of the most striking things about the data we've just presented from our 05 and 06 studies is the rapidity of onset,” Levine told 

. “In both cases, we were able to detect a clinically and statistically significant difference in MADRS reduction as of day 2, which is the first day after administration of COMP360. That is a rapidity of effect that we've never seen before.”

Levine said the rapid onset may reflect acute, network-level effects mediated through 5-HT2A receptor agonism. He noted that this mechanism appears distinct from those underlying currently available treatments for TRD.

In COMP006, two 25-mg doses of COMP360 administered 3 weeks apart demonstrated a –3.8-point least squares mean difference in Montgomery-Åsberg Depression Rating Scale (MADRS) score at week 6 compared with a 1-mg control (

 <.001). According to Levine, a 3-point MADRS difference is generally considered clinically meaningful in TRD, placing the 3.8-point separation above the accepted threshold for relevance.

He noted that the magnitude of effect is comparable to that observed in pivotal trials of esketamine (Spravato), currently the only FDA-approved medication specifically indicated for TRD. However, whereas esketamine’s approximately 4-point treatment difference was achieved after multiple administrations over 4 weeks, COMP360 demonstrated a similar effect size 6 weeks after a single administration in COMP005 and after 2 administrations in COMP006.

In Part B of COMP005, participants who achieved ≥ 25% reduction in MADRS at week 6 and received a second treatment demonstrated sustained benefit through week 26. Among those with an initial clinically meaningful response who underwent re-treatment, approximately 40% achieved remission. These findings suggest that 1 or 2 administrations may support symptom improvement lasting up to 6 months in responders.

Furthermore, in COMP005, 25% of participants receiving 25 mg achieved a ≥ 25% MADRS reduction versus placebo. In COMP006, 39% reached this threshold after a second administration.

“This is a level of improvement that is very likely to translate into really meaningful benefit for patients, particularly those who have treatment-resistant depression,” Levine said. “Even modest decreases in symptoms can have an outsized impact on the course of their care and the quality of their life.”

A relevant disclosure for Levine includes Janssen Pharmaceuticals, Inc.

Compass Pathways Successfully Achieves Primary Endpoint in Second Phase 3 Trial Evaluating COMP360 Psilocybin for Treatment-Resistant Depression. Compass Pathways. Published on February 17, 2026. Accessed on February 19, 2026. 

https://ir.compasspathways.com/News--Events-/news/news-details/2026/Compass-Pathways-Successfully-Achieves-Primary-Endpoint-in-Second-Phase-3-Trial-Evaluating-COMP360-Psilocybin-for-Treatment-Resistant-Depression/default.aspx

Derman C. COMP360 Psilocybin Meets Primary Endpoint in Second Phase 3 Trial for TRD. HCPLive. Published on February 19, 2026. Accessed on February 20, 2026. 

https://www.hcplive.com/view/comp360-psilocybin-meets-primary-endpoint-second-phase-3-trial-trd

Levine breaks down Compass Pathways’ phase 3 data on COMP360, highlighting next-day onset and sustained symptom improvement through 26 weeks.

Sustained Remission in Hard-to-Treat Crohn’s: Insights From SEQUENCE

New long-term data from the SEQUENCE program, presented at the 2026 Congress of the European Crohn’s and Colitis Organisation (ECCO), continue to reinforce the clinical impact of risankizumab (Skyrizi) in moderate-to-severe Crohn’s disease, particularly among patients with prior anti-TNF failure.

In discussing the findings, Raja Atreya, MD, head of the IBD Center at University Hospital

of Erlangen, characterized SEQUENCE as a “landmark” trial and emphasized that its design and durability data are directly shaping real-world decision-making.

“This is a head-to-head trial addressing an unmet need that we have in the treatment of our patients with exposure to anti-TNF therapy. This is a common clinical problem that we have,” Atreya explained. “I'm glad that I'm practicing in these times where we have a lot of therapeutic options. In the setting of previous anti TNF failure, where we already know these are hard to treat patients, because failure to anti TNF is like a surrogate marker for severe disease, hard to treat disease, refractory disease. So having these biological options is very nice, but when choosing the second advanced therapy, you have to make the right choice.”

He stressed that the head-to-head comparison of risankizumab and ustekinumab provided critically needed direct comparative data in this hard-to-treat population, something that has historically been lacking in Crohn’s disease.

The analysis included 224 patients who completed part 1 of the SEQUENCE study (week 48) and could receive risankizumab 360mg subcutaneously (SC) every 8 weeks in part 2, the open-label maintenance period of the SEQUENCE trial, starting at week 52.

Results showed patients with moderate-to-severe Crohn’s disease and prior anti-TNF failure, a population generally considered to have more refractory disease, demonstrated durable clinical remission, endoscopic response, endoscopic remission, and mucosal healing through 148 weeks of risankizumab treatment in the SEQUENCE study.

Of note, most patients who achieved clinical remission at week 8 maintained clinical remission throughout later time points, and clinical remission at week 148 was achieved by the majority (98.5% by CDAI; 88.1% by SF/APS) of week 8 clinical remitters.

Investigators additionally observed durability of clinical remission throughout later time points in patients who achieved clinical remission at week 48.

Of patients who achieved endoscopic response, endoscopic remission, or mucosal healing at week 24, 84.7%, 78.2%, and 67.3% of patients, respectively, maintained the corresponding endpoint at week 148. Similar results at week 148 were observed for patients who achieved these endoscopic endpoints at week 48.

Atreya further emphasized that early response appears to be the strongest predictor of long-term success. While molecular predictors remain elusive, he noted that patients who achieve early clinical and endoscopic remission are most likely to sustain benefit over time.

“With the amazing treatment results that we see in the SEQUENCE study and the sustained effectiveness seen in the open label extension studies, this is really something that helps us to position risankizumab high up in my personal therapeutic algorithm,” Atreya said.

Editors’ Note: Atreya reports relevant disclosures with AbbVie, Abivax, AlfaSigma, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion Healthcare, Gilead, GlaxoSmithKline, Johnson & Johnson, Lilly, Merck Sharpe & Dohme, Pfizer, Roche Pharma, Takeda Pharma, and others.

R Atreya, J Lindsay, M Ferrante, B Siegmund, Q Cao, S Van Haaren, J Crowley, T Anschutz, A Garrison, X Huang, M C Dubinsky, DOP004 Durable Efficacy of Risankizumab Through Week 148 in Patients With Moderate-to-Severe Crohn’s Disease: A Post Hoc Analysis of Part 2 of the SEQUENCE Study, 

, Volume 20, Issue Supplement_1, January 2026, jjaf231.041, 

https://doi.org/10.1093/ecco-jcc/jjaf231.041

Brooks A. Marla Dubinsky, MD: Clinical Outcomes with Risankizumab Versus Ustekinumab in SEQUENCE. HCPLive. February 24, 2024. Accessed February 20, 2026. 

https://www.hcplive.com/view/marla-dubinsky-md-clinical-outcomes-risankizumab-ustekinumab-sequence

SEQUENCE trial data highlight sustained 3-year clinical and endoscopic remission with risankizumab in anti-TNF–exposed Crohn’s patients.

How Head-to-Head SEQUENCE Data Shape Crohn’s Disease Treatment Decisions, With Raja Atreya, MD

chronic obstructive pulmonary disease (COPD) 

has undergone a quiet but profound reassessment. Once viewed as a largely homogeneous condition managed primarily with inhaled bronchodilators and corticosteroids, COPD is now increasingly understood as a biologically diverse disease with multiple inflammatory drivers. This evolving perspective has challenged long-standing assumptions about treatment limitations and opened the door to more individualized approaches.

Recent years have marked a pivotal shift, with biologic therapies—long established in asthma—beginning to demonstrate meaningful benefits in carefully selected COPD populations. Approvals such as dupilumab and mepolizumab have helped redefine what is possible for patients with persistent exacerbations and inflammatory phenotypes, signaling that disease biology, rather than diagnosis alone, may guide future therapy choices.

 These advances have reframed COPD not as a therapeutic dead end, but as a condition ripe for precision medicine.

convened a clinical forum led by Sarah Tomashefski, MSN, AGNP-C, FCCP, Lead Outpatient Pulmonary Advanced Practice Provider, and Director of the Pulmonary APP Fellowship program, Prisma Health, Greenville, South Carolina, focusing on how advanced practice providers (APP) and clinicians are now navigating how to translate emerging data into real-world practice. Questions around patient selection, biomarkers, safety, access, and guideline integration are shaping day-to-day decision-making. The clinical forum captured that moment of transition, reflecting a field actively recalibrating its approach to one of pulmonary medicine’s most challenging diseases.

“[The growing recognition of type 2 inflammation in COPD] opens the door past just the inhalers for a lot of us, where before it's like you get to a point with them and then they're just exacerbating. You're putting them on steroids. And it's like, well, now what do we do? We can see you again, treat you again. But you hit a limit with their treatment. So having the different biologics has definitely opened the door,” Alyssa Minute, DNP, APRN, FNP-C, Upstate Lung & Critical Care Specialists, said during the forum.

The forum explores how improved understanding of COPD heterogeneity has enabled more targeted therapeutic strategies, particularly through biologics aimed at type 2 inflammation. Participants detailed the importance of combining biomarkers such as eosinophil counts with clinical indicators like exacerbation history to identify patients most likely to benefit, while cautioning against indiscriminate use.

In addition to reviewing efficacy and safety considerations, the discussion highlighted practical challenges including reimbursement, workflow integration, and clinician education. Throughout, the conversation reinforced a central theme: the future of COPD management lies not in replacing existing therapies, but in layering precision-based options onto a foundation of optimized standard care.

“I know that there's this big push now for precision medicine. And I feel like just having biomarkers available to help kind of dictate the right tool for the right job is helpful and kind of meeting those new standards for a patient to - obviously, everyone should have individualized care, but it just helps kind of hone in even further [to find the] right tool for a job,” another attendee said.

Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. Regeneron Pharmaceuticals, Inc. September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html.

Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. News release. Article. HCPLive. https://www.hcplive.com/view/personalized-copd-treatment-lessons-biologic-trials-clinical-practice

Chronic obstructive pulmonary disease is increasingly recognized as a heterogeneous, biologically driven syndrome rather than a uniform airflow-limitation entity, creating momentum for precision-based escalation beyond inhaled therapies. Biologics long used in asthma are now demonstrating benefit in defined COPD subsets, with dupilumab and mepolizumab supporting a type 2 inflammation paradigm in patients with persistent exacerbations. Implementation hinges on rigorous patient selection using biomarkers (eg, blood eosinophils) plus exacerbation history, while addressing safety, reimbursement, workflow integration, and clinician education to layer targeted therapy onto optimized standard care.

Frontline COPD Care in the Biologic Era: Practical Insights From APPs

Just 1 year ago, semaglutide (Ozempic) was approved by the 

This approval marked an important milestone as the first GLP-1 receptor agonist to reduce the risk of worsening kidney disease, kidney failure, and death due to cardiovascular disease in these patient populations.

Semaglutide, initially developed by Novo Nordisk, received its first approval from the FDA under the name Ozempic on December 5, 2017. Its first indication was as an injection of 0.5 mg or 1 mg once weekly for glycemic control in patients with type 2 diabetes (T2D) – as an adjunct to diet and exercise.

Since then, semaglutide has exploded into nearly every related field. Glucagon-like peptide-1(GLP-1) receptors were discovered everywhere from the pancreas and the gastrointestinal tract to the heart, kidney, and liver. GLP-1 receptor agonists were quickly introduced into nephrology and cardiology, expanding their indications over the years to meet need in a variety of organs. Semaglutide has been at the forefront of this expansion due to its comparatively superior reductions of A1c, glucose, and overall weight.

In 2020, semaglutide received approval for the reduction of cardiovascular risk in patients with T2D, marking its entry into the cardiology sphere. In January of 2025, semaglutide became the first GLP-1 receptor agonist approved for worsening kidney disease, kidney failure, and death due to cardiovascular disease in patients with T2D and chronic kidney disease (CKD). This approval marked semaglutide’s entry into the full cardio-kidney-metabolic (CKM) disease spectrum, addressing mortality and worsening outcomes for major contributing diseases.

Now, just over a year after semaglutide’s approval for CKD, the editorial team at 

 has gathered insights from key clinicians across the CKM spectrum to discuss how this revolutionary drug overhauled the treatment landscape for kidney disease from all sides.

Semaglutide’s revolutionary impact on the endocrinology field cannot be understated. Despite not being the first, for years, this GLP-1 RA was the best method of reducing 3 major contributing factors to mortality in T2D. A1c reduction, glucose management, and weight loss saw substantial improvements as a result of the drug’s approval. However, semaglutide’s efficacy now extends far beyond T2D.

“I think that, sometimes, there’s hesitancy around starting a new therapy because the clinicians don’t know if other specialties will be on board,” Diana Isaacs, PharmD,

the director of Education and Training in Diabetes Technology and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and a member of 

 in an interview. “Now, we’re seeing through notes that nephrology is saying, ‘Why don’t you consider using semaglutide?’ And when they come to me as part of endocrinology, I see that, and I’m encouraged to use it. I think semaglutide really has enhanced team-based care in that we’re all on board.”

Isaacs went on to describe how semaglutide’s CKD approval provided a major paradigm shift for the American Diabetes Association’s standards of care.

“By showing its positive outcomes, particularly in people with kidney disease, semaglutide was paradigm-changing for the ADA Standards of Care and for our guidelines in that, previously, SGLT2 inhibitors were preferred for people with T2D and CKD,” Isaacs said. “Now, it’s either SGLT2 inhibitors or GLP-1 therapy – in practice, we’re now utilizing both of them.”

The Cardio-Kidney-Metabolic Landscape of Semaglutide

On October 9, 2023, the American Heart Association (AHA) released a presidential advisory regarding CKM syndrome, highlighting the interplay between metabolic risk factors, the cardiovascular system, and CKD. This syndrome has a significant impact on morbidity and mortality – poor CKM health, which is prominent among the American population, is associated with increased incidence of cardiovascular disease events.

“CKM syndrome encompasses the entire spectrum of risk, starting from people who have no risk factors or cardiovascular disease, going all the way through 

, vascular risk factors, subclinical disease, and clinical cardiovascular disease,” Janani Rangaswami, MD, professor of medicine at George Washington University and co-chair of the Scientific Advisory Group of the AHA’s presidential advisory on CKM Health, told 

 in an exclusive interview. “In any healthcare setting, the interplay between cardiology, nephrology, and endocrinology is the bulk of practice. In my practice, when I see individuals with kidney disease, diabetes alone is responsible for close to 50% of the cause of that kidney disease. When you add in obesity, metabolic dysfunction, and hypertension, all of these come together very heavily.”

Semaglutide’s approval for CKD effectively provided a bridge between all 3 specialties. When coupled with its initial diabetes indications and its cardioprotective effect, the drug was approved to tackle CKM syndrome on all fronts. Additionally, semaglutide’s efficacy when combined with SGLT2 inhibitors and RAAS blockade in patients with both CKD and high cardiovascular risk made it an effective tool for bolstering the protective effects of existing therapies. In this collaborative space between cardiology and nephrology, semaglutide became something of a miracle drug.

“While GLPs like semaglutide are very effective for A1c management and weight management, the FLOW trial really showed that this therapy saved lives, hearts, and kidneys,” Rangaswami said. “So now these therapies do multiple things; they’re addressing everything from improving lifespan to improving health outcomes, heart and kidney, and even beyond.”

The Bilateral Relationship Of CKD and Obesity

CKD remains one of the most common and serious complications of T2D, with obesity increasingly shaping disease trajectory, transplant eligibility, and therapeutic decision-making.

As global rates of obesity and CKD continue to climb, clinicians are paying closer attention to how excess adiposity directly affects renal physiology, independent of diabetes and hypertension.

“In obesity, metabolic demands increase, so the kidneys have to increase glomerular filtration rate and renal plasma flow to meet those demands. If nephron number is already reduced, the remaining nephrons have to work even harder. That leads to increased pressure inside each nephron, which causes barotrauma, scarring, and increased urine protein excretion,” explained Holly Kramer, MD, a nephrologist at Loyola University Medical Center and editor in chief of 

. “Severe obesity can also directly contribute to nephron loss through inflammatory effects. Often, obesity is accompanied by diabetes and hypertension, which further accelerate kidney disease progression.”

At BMI levels >40, systemic inflammation rises, adipokine signaling alters renal hemodynamics, and insulin resistance further increases glomerular stress. These processes frequently coexist with hypertension and T2D, amplifying cumulative kidney injury.

Despite this convergence of risk factors, CKD is often managed reactively rather than proactively. By the time patients reach end-stage kidney disease (ESKD) and require maintenance dialysis, obesity can create additional barriers to transplantation because of higher perioperative and postoperative complication risks. Increasingly, clinicians are focused on intervening earlier in the disease course.

In this landscape, GLP-1 agonists have emerged as a treatment strategy for patients with CKD and T2D, especially as a anti-imflammatory marker.

Subsequent research has shown an association of persistent low‑grade inflammation with worsened clinical outcomes in CKD, including faster eGFR decline, higher cardiovascular risk, and increased all‑cause mortality. Additionally, inflammation is a driving factor in the development and progression of T2D and its complications.

The reduction of inflammatory markers, such as CRP, has been highlighted as a potential clinical strategy to protect kidney function. In turn, semaglutide has been associated with reductions in CRP and other inflammatory markers independent of glycemic effects.

“GLP-1 receptor agonists have become another pillar we can use for people with chronic kidney disease. I see them being used as an adjunct to other medications, such as SGLT2 inhibitors and nonsteroidal mineralocorticoid receptor antagonists. Especially when used in conjunction with those therapies, I think they have kidney benefits,” said Kramer. “They reduce urine albumin-to-creatinine ratios. If patients lose weight, we improve blood pressure control. If they have type 2 diabetes, glucose control improves. All of those factors help slow kidney disease progression, so I think GLP-1 receptor agonists are a great addition to our existing armamentarium.”

Where Obesity, CKD, and T2D Intersect with Semaglutide: The FLOW Trial

The approval for semaglutide for patients with T2D and CKD was based on data from FLOW, a phase 3b, multinational, parallel-group, double-blind, randomized, placebo-controlled trial investigating the effects of 1.0 mg once weekly semaglutide, a once-weekly GLP-1RA, on kidney outcomes in participants with CKD and T2D.

“I think it has largely removed the uncertainty that once existed around the effects of GLP-1 receptor agonists on kidney function and has clearly demonstrated that these agents are kidney-protective,” FLOW study investigator, Vlado Perkovic, MBBS, PhD, and provost at the University of New South Wales, told 

 “That, in turn, has informed guideline updates and helped the clinical community accept GLP-1 receptor agonists as a fourth pillar of care for people with diabetic kidney disease. That is a major advance.”

FLOW included 3533 participants with T2D and CKD, with the composite primary endpoint being time to first kidney failure, defined as persistent eGFR <15 ml/min/1.73 m2 or initiation of chronic kidney replacement therapy, persistent ≥50% reduction in eGFR, or death from kidney or cardiovascular causes.

Over a median follow-up of 3.4 years, semaglutide reduced the risk of a primary outcome event by 24% compared with placebo (331 vs 410 first events; HR, 0.76; 95% CI, 0.66-0.88; P = .0003). Similar reductions were observed for the kidney-specific composite (HR, 0.79; 95% CI, 0.66-0.94) and cardiovascular death (HR, 0.71; 95% CI, 0.56-0.89).

All confirmatory secondary outcomes favored semaglutide, including a slower annual decline in eGFR (difference, 1.16 mL/min/1.73 m²; P <.001), an 18% reduction in major cardiovascular events (HR, 0.82; 95% CI, 0.68-0.98; P = .029), and a 20% lower risk of all-cause mortality (HR, 0.80; 95% CI, 0.67-0.95; P = .01). Serious adverse events occurred in 49.6% of the semaglutide group versus 53.8% with placebo.

Beyond Weight Loss: Inflammation and Future Directions of Semaglutide

Perkovic emphasized that FLOW was not intended to be a weight-loss trial, with a broad range of BMIs among participants, including 25% with BMI <27. While GLP-1 receptor agonists, especially semaglutide and emerging combination therapies, present efficacy regarding weight loss, FLOW indicated semaglutide’s specific kidney benefits not simply attributable to obesity treatment.

However, Perkovic also remarked on patterns from the FLOW trial’s participant population, where the mean BMI was 32. Additionally, in the CREDENCE trial, which also evaluated patients with T2D and CKD, the mean BMI was 31. This highlights obesity as a prevalent, rather than incidental, comorbidity in contemporary CKD populations. Taken together, these findings underscore the importance of considering body weight as a core component of CKD risk assessment, rather than a secondary concern.

“What that tells us is that people with diabetes and kidney disease are, on average, significantly overweight and often fall into the obese category. Many of these patients are therefore likely to benefit from weight loss as well,” explained Perkovic. “These therapies address multiple, parallel pathologies that commonly coexist in our patients, which makes them particularly exciting. It also raises the question of whether more potent agents that induce greater weight loss might confer additional kidney benefits, something that still needs to be tested.”

As obesity, T2D, and CKD increasingly converge in clinical practice, therapies capable of targeting overlapping metabolic, hemodynamic, and inflammatory pathways may redefine standard care. For clinicians managing complex kidney disease populations, GLP-1 receptor agonists now represent not simply a metabolic adjunct, but a foundational component of comprehensive CKD risk reduction.

Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others.

Rangaswami reports relevant disclosures with the Veterans Health Administration, Boehringer Ingelheim, Bayer, Procyrion, and the American Heart Association.

Kramer reports relevant disclosures with Bayer, Alexion, American Journal of Kidney Disease, National Kidney Foundation, and others.

Perkovic reports relevant disclosures with AstraZeneca, Bayer, Boehringer Ingelheim, and others.

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Semaglutide has expanded from a T2D glycemic agent to a cardio-kidney-metabolic therapy, culminating in FDA approval for reducing CKD progression, kidney failure, and CV death in T2D with CKD. Cross-specialty adoption is accelerating, reshaping guideline positioning alongside SGLT2 inhibitors and enabling combination strategies with RAAS blockade and nsMRAs. Obesity is increasingly recognized as a direct mediator of renal injury via hyperfiltration, inflammation, and nephron stress, influencing progression and transplant candidacy. FLOW established kidney and survival benefits beyond weight loss.

1 year into real-world use, 4 clinicians discuss how semaglutide is transforming the endocrinology, nephrology, and cardiology landscape.


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