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.

Vixarelimab therapy demonstrated rapid, sustained, dose-dependent clinical benefits among individuals with 

, according to new findings, as well as a favorable safety profile.

The drug was designed as a first-in-class human monoclonal antibody for patients with prurigo nodularis, targeting oncostatin M (OSM) β and inhibiting both OSM and interleukin (IL)-31 signaling pathways. This analysis, authored by investigators such as Sonja Ständer, MD, of Münster University Hospital, was conducted to look at the medication’s long-term efficacy and safety as well as pharmacokinetic profiles of monthly vixarelimab doses.

Ständer et al highlighted prior phase 2a data in which reduction of pruritus was observed among prurigo nodularis patients, along with attainment of clear or almost clear skin in one-third of subjects on the drug by Week 8.

“Here, we report results from the phase 2b trial evaluating the efficacy, safety, tolerability, and pharmacokinetics of monthly dosed vixarelimab in participants with [prurigo nodularis] with moderate to severe pruritus over 16 weeks,” Ständer and coauthors wrote.

The investigative team conducted this analysis in the period between December 2020 - August 2023. They included a 4-week phase for screening, a 16-week randomized double-blind treatment phase, and a subsequent 36-week open-label extension period. The study resulted in a total potential participation time of approximately 56 weeks per patient.

Participants were involved at 72 clinical sites found around Canada, the US, Europe, and Asia. Adults in the age range of 18 - 80 years with a verified diagnosis of prurigo nodularis lasting 6 months at minimum. Those taking part as subjects were also required to have moderate to severe itch at both screening and baseline. Moderate to severe itch was defined by Ständer and colleagues as the presence of at least 20 pruritic nodules measuring 0.5 to 2 cm distributed across a minimum of 2 distinct regions of the body.

Severe itch was characterized by a Worst Itch Numeric Rating Scale (WI-NRS) score of 7 or higher at screening and an average weekly WI-NRS score of at least 7 during the week before randomization, based on a minimum of 5 daily entries recorded in an electronic diary. In addition, participants were required to have a prurigo nodularis Investigator Global Assessment score of 3 or greater, indicating at least moderate disease severity on a 0-to-4 scale.

In the double-blind phase lasting 16 weeks, those in the study were randomly assigned by Ständer et al to be subcutaneously treated with doses of vixarelimab at 540 mg, 360 mg, or 120 mg, or matching placebo. The drug was administered on an every-4-week basis. During the open-label extension period, all involved were given 360 mg vixarelimab every 2 weeks for 36 weeks.

The study's primary and key secondary efficacy measures evaluated in the study included the proportion of subjects attaining at least 4-point reduction in WI-NRS by the 16-week mark, the percentage shift seen from the point of baseline in WI-NRS at the same time point, and the proportion attaining a 0 or 1 score on the prurigo nodularis Investigator Global Assessment at the same point.

189 of the 190 people who were randomized by Ständer and coauthors were given at least a single medication dose. These individuals included 141 and 48 assigned to vixarelimab or placebo, respectively. The study was made up of 60.3% women and 39.7% men. The participants' mean age was 55.4 years. Each vixarelimab dose group included 47 individuals. Treatment with vixarelimab at the 16-week mark led to significantly increased mean WI-NRS score reductions compared with placebo across all dosing cohorts.

Reductions were shown by the investigators to be as follows:

−56.2% among those in the high-dose arm

At least a 4-point reduction in WI-NRS scores was seen by Ständer et al in 31 66.0% of those on high-doses of the drug, 61.7% of those in the mid-dose arm, and 29.8% in the low-dose arm. This was compared with 16.7% in the placebo arm of the study. Attainment of Investigator Global Assessment scores of 0 or 1 was also more commonly identified among participants treated with vixarelimab. Specific percentages were as follows:

Additionally, the drug's safety profile was highlighted by Ständer and colleagues following the analysis. There were no fatal events or serious treatment-emergent adverse events (TEASs) attributed to the medication reported in the study.

“Overall, mild TEAEs were observed with vixarelimab, with no fatal or serious drug-related TEAEs reported and no serious treatment-related TEAEs observed during the DB period,” the investigative team concluded.

 “These results highlight the favorable benefit-risk profile of vixarelimab.”

Ständer S, Yosipovitch G, Sofen H, et al. Vixarelimab in Patients With Prurigo Nodularis: A Randomized Clinical Trial. JAMA Dermatol. Published online December 17, 2025. 

Sofen H, Bissonnette R, Paolini JF, et al. Efficacy and safety of vixarelimab, a human monoclonal oncostatin M receptor β antibody, in moderate-to-severe prurigo nodularis: a randomised, double-blind, placebo-controlled, phase 2a study. EClinicalMedicine. 2023 Feb 3;57:101826. 

Articles

Vixarelimab, a first-in-class human monoclonal antibody, has shown promising results in treating prurigo nodularis by targeting oncostatin M β and inhibiting OSM and IL-31 pathways. A phase 2b trial demonstrated significant reductions in pruritus and improved skin conditions over 16 weeks, with a favorable safety profile. Participants receiving vixarelimab experienced greater reductions in itch severity compared to placebo, with no serious treatment-related adverse events reported. These findings suggest vixarelimab as a potential therapeutic option for patients with moderate to severe prurigo nodularis.

Investigators observed rapid, sustained clinical benefits after using vixarelimab in patients living with prurigo nodularis.

Dermatology

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Vixarelimab Demonstrates Rapid, Sustained Clinical Benefits in Prurigo Nodularis

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Debate on whether early IL-23–targeted therapy like ICO could delay or prevent PsA onset.

Oral vs Biologic IL-23: Key Factors That Impact Treatment Decisions 

, despite the expanding therapeutic landscape. Linda Stein Gold, MD, and her colleagues analyze patient- and provider-reported data from the 

 surveys, revealing that many patients remain dissatisfied with current therapies and that oral agents are overwhelmingly preferred over injectables. The experts discuss how patient lifestyle, comorbidities, and psychosocial burden influence shared decision-making and treatment adherence. They also interpret the 

International Psoriasis Council’s (IPC)

 and explore its implications for reducing “topical churn” and advancing systemic therapy earlier in the disease course.

 and its potential to close current gaps in care. The panel provides an in-depth review of the 

 clinical development program, summarizing the 

 trials, which demonstrated superior efficacy versus deucravacitinib at both 16 and 24 weeks, with favorable safety and tolerability. They also discuss new 

 showing sustained clearance and no new safety signals in adults and adolescents. The faculty reflect on ICO’s implications for adolescent psoriasis and how early, aggressive oral intervention may help prevent progression to psoriatic arthritis, marking a significant milestone in the evolution of oral IL-23–targeted therapy.

The final portion of the series shifts focus to 

managing active psoriatic arthritis (PsA)

. The experts discuss new findings from the 

 demonstrated the first clear evidence of IL-23–mediated inhibition of structural joint damage, reinforcing the rationale for early biologic use in high-risk patients. They compare APEX to prior IL-23 studies, discuss implications for therapy sequencing, and highlight other emerging data from 

 studies. In closing, Stein Gold and colleagues emphasize a forward-looking approach that integrates personalized therapy selection, early detection of PsA, and cross-specialty collaboration to elevate standards of psoriasis care

Videos

Video Series

Examination of unique challenges and the importance of early, effective therapy in younger patients.

Expert Perspectives on First-In-Class IL-23 Oral Peptide 

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

 are linked to more frequent exacerbations, poorer asthma control, reduced quality of life, and increased healthcare utilization, independent of lung function severity.

“These data define a more difficult-to-treat asthma phenotype that need to be further investigated, and it might be indicative of the complex interplay between sleep and asthma control, suggesting that treatment for sleep disorders might be an overlooked therapeutic target to reduce the need for intensive asthma therapy and improve outcomes,” wrote study investigator Sebastian Ferri, from IRCCS Humanitas Research Hospital in Italy, and colleagues.

Growing evidence has highlighted a bidirectional relationship between asthma and sleep disorders.

Sleep disturbances, including snoring, frequent awakenings, and daytime sleepiness, are common among patients with asthma and are associated with worse asthma control, increased exacerbations, and impaired quality of life.

The team sought to assess the link between sleep disorders and severe asthma. Using data from the Severe Asthma Network Italy (SANI) registry, this retrospective analysis assessed the prevalence and overall burden of sleep disorders in patients with severe asthma, while also identifying related clinical features, risk factors, and treatable traits.

 Participants were stratified based on the presence or absence of sleep disorders at baseline.

Among 1823 participants with severe asthma, approximately 1 in 4 suffered from a concomitant sleep disorder (26.1%), with 5.5% diagnosed with obstructive sleep apnea (OSA), and 20.5% reported to snore.

“The high prevalence of sleep disorders in our cohort underscores the importance of considering sleep disorders as a comorbidity in patients with severe asthma,” investigators wrote.

Investigators noted that polysomnography data were not available for all patients, which could explain the discrepancy between snoring and OSA. There may be undiagnosed cases of OSA or respiratory-related disorders.

In this study, sleep disorders were more common in overweight patients, which aligns with previous research that found that being overweight is a risk factor for sleep disorders, such as OSA.

Patients with severe asthma and a comorbid sleep disorder also had more frequent rhinitis, chronic rhinosinusitis with and without nasal polyps, gastroesophageal reflux disease (GERD), cardiovascular disease (CVD), and type II diabetes. Additionally, they had greater rates of intranasal corticosteroid use and a greater need for systemic corticosteroids due to increased exacerbation rates.

The study revealed that participants with severe asthma and a comorbid sleep disorder had less severe lung function but worse asthma control and quality of life. These patients also had increased asthma-related hospital admissions and unscheduled medical visits.

“The finding that these patients have worse asthma control and quality of life, despite less severe functional impairment based on FEV1, may indicate that sleep disturbances are an important factor in the overall management of asthma,” investigators wrote.

 “As found by Teodorescu et al, individuals with OSA are 3.6 times as likely to have uncontrolled asthma, [which] leads to a higher number of disease-related hospital admissions and the need [for] non-programmed medical visits.”

Investigators identified several risk factors for sleep disorders in this population: being overweight or having moderate-to-severe rhinitis, chronic rhinosinusitis with and without nasal polyps, GERD, and CVD.

“Considering the overall results of our study, we confirm and strengthen the concept that sleep disorders are a common and relevant clinical feature among patients with severe asthma, and physicians should consider investigating patients’ sleep quality in their daily clinical practice,” investigators concluded. “It is important to consider asthma and sleep disorders as two entities which can influence each other, and only treating properly both we could improve patient quality of life and reduce healthcare burden."

Ferri S, Marzio V, Cavaglià E, et al. Severe Asthma and Sleep Disorders: A Severe Asthma Network Italy (SANI) Registry Analysis. 

. 2025;18:1661-1673. Published 2025 Dec 1.

Ferreira NB, Ponte A, Grande AC, et al. Frequency of obstructive sleep apnea in patients with asthma or allergic rhinitis: a systematic review and meta-analysis. 

Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. 

Severe asthma is often accompanied by sleep disorders, which are linked to increased exacerbations, poorer asthma control, and higher healthcare utilization, regardless of lung function severity. This suggests a complex interplay between sleep and asthma, highlighting sleep disorders as a potential therapeutic target. A study using data from the Severe Asthma Network Italy found that 26.1% of patients with severe asthma had sleep disorders, with obesity being a significant risk factor. Addressing sleep disorders in asthma management could improve patient outcomes and reduce healthcare burdens.

Registry data show worse asthma control, more exacerbations, and higher healthcare utilization in patients with severe asthma and a comorbid sleep disorder.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

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.

Sleep

On the HCPLive sleep page, resources on the topics of medical news and expert insight into sleep medicine can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sleep apnea, insomnia, narcolepsy, and more.

Sleep Disorders Linked to Poorer Symptom Control in Severe Asthma

Updates in Remibrutinib from ACAAI 2025

Recent presentations at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 and European Academy of Dermatology and Venereology provided additional insights into the clinical and immunologic effects of remibrutinib in chronic spontaneous urticaria (CSU). In this video Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, breaks down Data demonstrating remibrutinib’s efficacy and safety across both major CSU subtypes—autoallergic (type I) and autoimmune (type IIb).

Analysis of the REMIX trials and additional substudies highlighted remibrutinib’s robust efficacy in patients previously unresponsive to omalizumab, the first FDA-approved biologic for CSU. Even among those who were refractory to this established treatment, remibrutinib achieved high response rates, supporting its utility as a second-line or rescue therapy in difficult-to-treat populations. This finding is of particular clinical significance, given the historical reliance on immunosuppressive agents for patients who failed standard therapies.

The breadth and quality of evidence presented at ACAAI 2025 solidify remibrutinib’s standing as a versatile agent within the CSU therapeutic armamentarium, with its oral administration, rapid onset of action, effective disease modification, and broad applicability positioning it as an integral component of individualized, guideline-driven CSU management. Ongoing updates to clinical practice recommendations are anticipated to further define remibrutinib’s role in routine care.

Shyam Joshi, MD, reviews clinical and mechanistic data on remibrutinib in chronic spontaneous urticaria, as presented at ACAAI 2025 and EADV 2025.


Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The highly selective oral TYK2 inhibitor met coprimary endpoints for sPGA 0/1 and PASI 75 at week 16 versus placebo in the phase 3 Latitude studies.

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.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

A retrospective cohort study developed and validated a predictive model for IgA nephropathy, using routinely available variables. 


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.

IgA Nephropathy

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

IgA Nephropathy Prediction Model Aids 5-Year Survival Estimation

In this episode, a panel of dermatologists join to discuss the impact of the Boards University educational initiative for residents and early-career physicians.

The Medical Sisterhood, with Mona Shahriari, MD

The Medical Sisterhood, hosted by Mona Shahriari, MD, is a podcast dedicated to empowering female physicians by providing a platform for shared experiences, mentorship, and support. 

Each episode delves into the unique challenges women in medicine face, including work-life balance, leadership roles, and overcoming gender biases. Shahriari aims to inspire women to lead fulfilling professional and personal lives on their own terms through candid discussions and expert interviews. 

e as we foster a community where women can uplift and support each other in achieving their goals!

Podcasts

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The Medical Sisterhood: Redefining Leadership and Mentorship in Dermatology

Julian Zorrilla, DO, is a pediatric hematologist and oncologist at Nemours Children's Health.

Zorrilla discusses the safety and efficacy of a series of minor surgeries in patients with hemophilia A/B currently taking fitusiran to control AT levels.

Hematology

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Minor Surgeries Safe to Perform in Patients Receiving Fitusiran Prophylaxis, With Julian Zorrilla, DO

AASLD and AST have released 2 new guidelines on evaluating adult liver transplant candidates and managing non-graft complications after transplantation.

Hepatology

AASLD Releases New Liver Transplantation Practice Guidelines on Candidacy, Management

DBV Technologies announced that the phase 3 VITESSE trial on VIASKIN® Peanut patch for peanut-allergic children met its primary endpoint.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Food Allergy

VIASKIN Peanut Patch Effective in Peanut-Allergic Children Aged 4–7 Years

Haris Sohail, MBBS, is a hematology and oncology fellow at Charleston Area Medical Center.

Sohail discusses the promising results from this retrospective cohort study which aims to put longstanding concerns about worsening infection to bed.

Anemia

IV Iron Reduces Mortality Risk in Iron Deficiency Anemia Without Increasing Infection Severity, With Haris Sohail, MBBS

A meta-epidemiologic study highlights barriers to inclusion of older adults undergoing maintenance dialysis in randomized controlled trials. 


Older Patients on Maintenance Dialysis Underrepresented in RCTs

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.

Explore the latest advancements in diabetes technology, including updates on CGMs and insulin pumps, enhancing patient care and management.

Type 2 Diabetes

Type 1 Diabetes

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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.

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Diabetes Dialogue: 2026 Technology Updates and American Diabetes Association Standards of Care

A large prospective cohort study showed that moderate dietary diversity, particularly greater intake of grains, dairy, vegetables, and fruits, is linked to reduced gout risk.

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Latest News

Vixarelimab Demonstrates Rapid, Sustained Clinical Benefits in Prurigo Nodularis

Oral vs Biologic IL-23: Key Factors That Impact Treatment Decisions

Expert Perspectives on First-In-Class IL-23 Oral Peptide

Sleep Disorders Linked to Poorer Symptom Control in Severe Asthma

Updates in Remibrutinib from ACAAI 2025