Frances Lee, MD, is an assistant professor of medicine in the division of liver diseases at Mount Sinai.

New Fatigue Signals From Elafibranor: Results From the ELATIVE Phase III Trial

This episode, titled “New Fatigue Signals From Elafibranor: Results From the ELATIVE Phase III Trial” features panelists discussing highlighting recent data on elafibranor and how changes in fatigue/pruritus were largely independent from biomarker changes. Clinicians then discuss how this information may impact future treatment decisions.

Led by the moderator, the experts examine the following critical questions:

Results announced from EASL and AASLD this year revealed that changes in fatigue and pruritus for patients on elafibranor from the phase III ELATIVE trial were largely independent from biomarker changes. Can you expand upon the clinical significance of these findings, especially for patients with severe symptomatic burden?

Looking ahead, how can clinicians utilize this information to make targeted treatment decisions?

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

In the final episode, “Future Advancements in PBC Care: Innovations on the Horizon” panelists will continue their discussion on PBC and highlight investigational

Videos

New studies reveal potential benefits of alfagimor in reducing fatigue and pruritus, highlighting its role in second-line therapy for patients.

Addressing Fatigue: Traditional Management Outside Primary Therapy

In this episode, experts delve into the limited treatment options to address the symptom of fatigue in patients with primary biliary cholangitis. They highlight how small changes, like regular sleep schedules and exercise, can improve fatigue.

Led by the moderator, the panelists examine the following critical questions:

How have clinicians historically treated symptoms of fatigue? Please describe your treatment approach and how it may differ between moderate and severe cases of primary biliary cholangitis.

Without a remedy for fatigue, how do you educate and coach patients with severe fatigue on managing their symptoms?

Our next episode, “New Fatigue Signals From Elafibranor: Results From the ELATIVE Phase III Trial” further explores PBC, highlighting recent data on elafibranor and how changes in fatigue/pruritus were largely independent from biomarker changes.

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Dupilumab significantly reduces urticaria activity by lowering 

 symptom severity in anti-IgE–naive individuals who remained symptomatic despite using histamine 1–receptor antagonists (H1-AH; antihistamines).

These findings, resulting from the CUPID-C randomized clinical trial, confirmed previous findings from CUPID-A.

 Thomas B. Casale, MD, of the Division of Allergy and Immunology at the University of South Florida, Tampa Department of Medicine, authored these data alongside a team of other investigators.

Casale and coauthors set out to “further evaluate the efficacy and safety of dupilumab vs placebo in anti-IgE–naive patients with CSU uncontrolled by H1-AH.”1

The investigative team determined participants eligible to be involved would be between 6 - 80 years of age and have a CSU diagnosis at least 6 months prior to screening. All had reported persistent itch and hives for more than 6 consecutive weeks despite treatment with H1-AH during this interval. Patients were required to be on a protocol-specified H1-AH regimen for CSU with a stable dose for 3 consecutive days before screening at minimum, allowing doses up to 4 times the recommended amount, or up to twice the recommended dose in Japan. None had previously been treated with omalizumab therapy.

The CUPID-C analysis was designed to replicate the earlier LIBERTY-CSU CUPID-A trial. It lasted 24 weeks and used a phase 3, multicenter, randomized, double-blind, placebo-controlled study design. Casale et al assessed dupilumab utilization in anti-IgE–naive individuals with CSU who continued to have symptoms despite H1-AH use. It was conducted across 9 countries: Argentina, China, Canada, France, Hungary, Germany, Japan, the US, and Spain.

The primary efficacy endpoint in CUPID-C, as well as in pooled analyses of CUPID-A and CUPID-C, was the change from baseline to week 24 in either the 7-day Itch Severity Score (ISS7) or the 7-day Urticaria Activity Score (UAS7), with the alternate measure designated as a key secondary endpoint according to regional regulatory guidance. Statistical analyses were carried out between August and September 2024.

In CUPID-C, the investigative team involved 151 participants, with a mean age of 44.7 years and 70.2% being female. At the point of baseline, 51% were on H1-AH at doses exceeding the recommended level. Additionally, the team found 59.6% had a UAS7 score of 28 or higher. By the 24-week mark, dupilumab use was linked with significantly greater reductions in both ISS7 and UAS7 compared with placebo. The least squares mean (SE) shift in ISS7 was −8.64 (1.41) with dupilumab as opposed to −6.10 (1.40) with placebo.

This corresponded with a between-group difference of −2.54 points (95% CI, −4.65 to −0.43; 

 = .02). For UAS7, Casale and coauthors found the least squares mean (SE) change was −15.86 (2.66) among those in the dupilumab arm of the study, compared with −11.21 (2.65) in the placebo arm, yielding a difference of −4.65 points (95% CI, −8.65 to −0.65; 

 = .02). When Casale and colleagues pooled the data from CUPID-A and CUPID-C, encompassing 289 patients, improvements in both UAS7 and ISS7 were shown to be greater with dupilumab than with placebo.

In their safety findings, the results were found to have aligned with the established safety profile of dupilumab. In the investigators’ combined analysis, treatment-emergent adverse events (TEAEs) were reported in 53.5% of the subjects on dupilumab and 55.9% of those on placebo. Overall, the CUPID-C randomized study corroborated the results of CUPID-A, with the pooled findings suggesting dupilumab significantly diminished overall urticaria activity by lessening both itch intensity and hive severity in these individuals.

“These results are consistent with the findings from the previous replicate study, CUPID-A,” Casale and colleagues wrote.

 “The combined data from CUPID-A and -C collectively reinforce the clinical benefits and safety profile of dupilumab for H1-AH−refractory and omalizumab-naive patients with CSU.”

Casale TB, Saini SS, Ben-Shoshan M, et al. Dupilumab in Patients With Chronic Spontaneous Urticaria: Phase 3 LIBERTY-CSU CUPID Randomized Clinical Trials. JAMA Dermatol. Published online February 18, 2026. 

Maurer M﻿, Casale TB﻿, Saini SS﻿, et al. Dupilumab in patients with chronic spontaneous urticaria (LIBERTY-CSU CUPID): two randomized, double-blind, placebo-controlled, phase 3 trials. J Allergy Clin Immunol. 2024;154(1):184-194. doi:10.1016/j.jaci.2024.01.028.

Articles

Dupilumab improved chronic spontaneous urticaria control in omalizumab-naive patients who remained symptomatic despite protocol-specified H1-antihistamine regimens, including up-dosing. In the 24-week, phase 3, multicenter CUPID-C trial (n=151; mean age 44.7; 70.2% female), dupilumab produced statistically significant reductions in itch (ISS7) and overall activity (UAS7) versus placebo, with benefits reinforced in pooled CUPID-A/C analyses (n=289). Safety signals were comparable to placebo and consistent with the established dupilumab profile.

The CUPID-C randomized clinical trial confirmed CUPID-A results, with dupilumab significantly reducing urticaria in anti-IgE–naive individuals with CSU.

Urticaria

The HCPLive urticaria page is a comprehensive resource for clinical news and insights on chronic idiopathic urticaria and chronic spontaneous urticaria. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for urticaria, and more.

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The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Dupilumab Reduces Urticaria Activity in Anti-IgE–Naive Patients with CSU

COMP360 Safety Data in Phase 3 TRD Trials, With Steve Levine, MD

New phase 3 data from COMP005 and COMP006 further clarify the safety and tolerability profile of COMP360, a synthetic psilocybin, in treatment-resistant 

, Steve Levine, MD, chief patient officer at Compass Pathways, emphasized that most treatment-emergent adverse events (TEAEs) were transient and resolved within 24 hours of administration.

Unlike traditional oral antidepressants, which are associated with chronic daily exposure and cumulative adverse event burden, COMP360 is administered episodically in a supervised setting. Across both phase 3 trials, the majority of adverse events occurred on the dosing day and were generally mild to moderate in severity.

Adverse events were dose-dependent but typically resolved by the following day. The most commonly reported events included headache, nausea, fatigue, anxiety, and visual hallucinations.

“They were transient, and so it suggests a very tolerable profile for patients,” Levine told 

Suicidality remains a critical concern in TRD populations, where baseline risk is inherently elevated. Levine highlighted that across Part A of both COMP005 and COMP006, as well as longer-term follow-up through 26 weeks in COMP005, there was no imbalance in suicidal ideation or behavior between treatment arms. The study had < 1% reports of suicidality.

Questions remain regarding optimal retreatment frequency and long-term maintenance. Data to date suggest that 1 or 2 administrations may provide benefit lasting up to 6 months in responders. Additional 26-week data from COMP006 Part B are expected to further clarify retreatment intervals and inform real-world implementation, including payer considerations. Levine characterized the anticipated model as episodic rather than maintenance-based therapy.

Although COMP360 requires multi-hour supervised administration, Levine pointed to > 7000 US sites currently certified to administer esketamine nasal spray as a potential infrastructure foundation. The team-based delivery model used for esketamine, including psychiatrists, licensed healthcare professionals, and support staff, may be readily adaptable.

If approved, Levine suggested COMP360 could introduce a fundamentally different treatment paradigm in TRD, defined by rapid onset, limited dosing sessions, and durable benefit.

“For patients living with treatment-resistant depression, there currently is only one marketed pharmacologic option, which is Spravato,” Levine said. “That is a treatment that, while relatively rapidly acting, represents a high burden on patients and their caregivers given the frequency of induction treatment, as well as the frequency of maintenance treatment, which we [need] to maintain the effect. COMP360, with the rapidity and durability that we have now demonstrated in phase three, with the efficacy detectable on the first day following administration…represents an entirely new paradigm of care.”

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 discusses 24-hour adverse event resolution, retreatment questions, and scalability of supervised psilocybin therapy for treatment-resistant depression.

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

Ron Vender, MD, is a dermatologist in Hamilton, Ontario, and is the founder and director of Dermatrials Research Incorporated and Venderm Consulting Inc. He is also an associate clinical professor at McMaster University in the Department of Medicine, Division of Dermatology.

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

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

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Podcasts

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

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 2 Diabetes

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Diabetes Dialogue: Implantable Insulin Pumps and Interoperability

Hepatology

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

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

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

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

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Venous Thromboembolism

The HCPLive venous thromboembolism page is a resource for medical news and expert insights on VTE. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for thrombotic disease, and more.

AHA and ACC Release First Guideline for Pulmonary Embolism Treatment

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

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

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

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

Raja Atreya, MD, is head of the IBD Center at University Hospital

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

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

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

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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

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


Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

1 Year After CKD Approval, Semaglutide Transforms Diabetes, Kidney, and Heart Care

This interview with Vender highlights recent findings on patient-reported outcomes (PROs) in patients in the BE RADIANT trial with psoriasis.

3-Year Patient-Reported Psoriasis Outcomes for Bimekizumab, With Ron Vender, MD

Panaccione recaps interim PROFUNDUS data showing real-world efficacy and safety of upadacitinib (Rinvoq) for ulcerative colitis.

Latest News

New Fatigue Signals From Elafibranor: Results From the ELATIVE Phase III Trial

Addressing Fatigue: Traditional Management Outside Primary Therapy

Dupilumab Reduces Urticaria Activity in Anti-IgE–Naive Patients with CSU

COMP360 Safety Data in Phase 3 TRD Trials, With Steve Levine, MD

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