Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

 has approved icotrokinra (Icotyde) for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. 

The approval, announced by Johnson & Johnson on March 18, 2026, marks the first for an oral targeted peptide selectively blocking the IL-23 receptor and introduces a new mechanistic class to the psoriasis treatment landscape backed by data from multiple trials in the phase 3 ICONIC program.¹

“[Icotrokinra] delivers something unique in psoriasis treatment – combining skin clearance with a favorable safety profile in a once‑daily pill, making it an easy addition to a patient’s routine," said Linda Stein Gold, MD, director of Dermatology Clinical Research at Henry Ford Health. “With new guidance from the International Psoriasis Council that clarifies when to move beyond cycling on topical treatments to systemic therapy, an innovative option like [Icotrokinra]  is a potential game‑changer for many adult and adolescent patients.”

ICONIC Phase 3 Program: From LEAD to ADVANCE

The approval is based on results from 4 phase 3 trials in the ICONIC program, enrolling approximately 2500 patients aged 12 and older. The program began with ICONIC-LEAD, a multicenter, randomized, double-blind, placebo-controlled study that first established the agent's efficacy and safety profile across adults and adolescents. Results indicated 65% of patients treated with icotrokinra achieved an IGA score of 0 or 1 at 16 weeks, compared to 8% of the placebo group (

 <.001), and PASI 90 response rates were 50% for icotrokinra versus 4% for placebo (

Responses deepened with continued treatment: by week 24, 74% reached an IGA score of 0 or 1 and 65% achieved PASI 90, with 46% achieving complete skin clearance (IGA 0) and 40% reaching PASI 100.² In the adolescent subgroup, results were particularly strong, with 86.4% achieving IGA 0/1 and 88.6% achieving PASI 90 at week 24.²

A notable strength of the ICONIC program was its head-to-head design. ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 evaluated icotrokinra against both placebo and deucravacitinib in adults with moderate to severe plaque psoriasis.

Icotrokinra met both co-primary endpoints compared to placebo at week 16 and showed superiority to deucravacitinib for skin clearance at weeks 16 and 24, with adverse event rates numerically lower with icotrokinra relative to deucravacitinib through 24 weeks.³ Across the ICONIC-ADVANCE studies, approximately 70% of patients achieved IGA 0/1 and 55% achieved PASI 90 at week 16.¹

The program also specifically addressed high-impact disease sites through ICONIC-TOTAL, which evaluated patients with at least moderate severity affecting the scalp, genitalia, or hands and feet. At week 52, icotrokinra achieved clear or almost clear skin in 72% of patients with scalp psoriasis and 85% with genital psoriasis, with clearance rates in both sites substantially exceeding those seen with placebo at week 16.¹

Across the full program, rates of adverse reactions in icotrokinra-treated patients were within 1.1 percentage points of placebo through week 16, and no new safety signals were identified through week 52.¹

Johnson and Johnson has also initiated ICONIC-ASCEND, a head-to-head phase 3 trial comparing icotrokinra against ustekinumab, which would represent the first study designed to demonstrate superiority of an oral agent versus an injectable biologic in moderate to severe psoriasis, according to the company. Phase 3 studies in psoriatic arthritis, ulcerative colitis, and Crohn's disease are also underway, reflecting the broader relevance of IL-23 receptor blockade across immune-mediated conditions.¹

Johnson and Johnson. FDA approves ICOTYDE (icotrokinra), the first and only targeted oral peptide IL-23 receptor antagonist, for the treatment of moderate-to-severe plaque psoriasis. Press release. Published March 18, 2026. Accessed March 18, 2026. 

https://www.jnj.com/media-center/press-releases

Smith T. Phase 3 findings suggest icotrokinra effective in adults, adolescents with psoriasis. 

. Published August 08, 2025. Accessed March 18, 2026. 

https://www.hcplive.com/view/phase-3-findings-suggest-icotrokinra-effective-adults-adolescents-with-psoriasis

Campbell P. ICONIC-ADVANCE: icotrokinra bests deucravacitinib for plaque psoriasis. 

. Published September 17, 2025. Accessed March 18, 2026. 

https://www.hcplive.com/view/iconic-advance-icotrokinra-bests-deucravacitinib-for-plaque-psoriasis

Articles

The FDA approved icotrokinra for moderate to severe plaque psoriasis in adults and adolescents ≥12 years and ≥40 kg eligible for systemic therapy or phototherapy. As a once-daily oral targeted peptide selectively antagonizing the IL‑23 receptor, it introduces a new mechanistic class. Across ~2500 patients in the phase 3 ICONIC program, robust skin clearance was demonstrated versus placebo, with responses deepening through week 24 and durable benefit through week 52, including high-impact sites. Safety approximated placebo early, without new signals to one year.

FDA clears once-daily icotrokinra for moderate-to-severe plaque psoriasis in adults and teens.

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clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

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.

Dermatology

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.

FDA News

Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

Overview of KIT D816V–driven disease biology in ISM and practical approaches to longitudinal symptom monitoring, including emerging use of the Mastocytosis Control Test.

Reframing “Benign” Disease: The Modern Clinical Impact of Indolent Systemic Mastocytosis

Indolent systemic mastocytosis (ISM) is tightly linked to activating mutations in KIT, most commonly the D816V substitution in the intracellular domain, which drives mast cell survival, activation, and differentiation. This mutation results in constitutive signaling that promotes expansion of the mast cell compartment beyond physiologic requirements. Although KIT D816V was first characterized in advanced variants of systemic mastocytosis, improvements in molecular diagnostics have revealed its presence in more than 95% of patients with ISM, typically restricted to mast cells in indolent disease and extending to additional myeloid lineages in advanced forms. The strong concordance between KIT D816V and clinical mastocytosis, together with the observed reduction in disease manifestations when mutant mast cells are depleted, supports its role as a bona fide disease-driving lesion.

Because ISM is characterized by chronic, fluctuating multisystem symptoms, longitudinal assessment is central to optimal management. Clinicians must routinely evaluate dermatologic (spots, flushing, pruritus), gastrointestinal (diarrhea, abdominal pain, bloating), and neurocognitive (fatigue, “brain fog,” anxiety) domains, as well as major complications such as Hymenoptera venom–induced anaphylaxis. Historically, symptom evaluation relied primarily on unstructured dialogue and physical examination, but there is increasing interest in formal patient-reported outcome (PRO) measures. The Mastocytosis Control Test (MCT), a brief 5‑item patient-completed instrument scored from 0 to 4 per item, was developed to capture disease impact over the preceding 2 weeks and is conceptually analogous to validated tools used in asthma, urticaria, and allergic rhinitis.

Although the MCT has not yet been universally adopted in routine practice, its simplicity makes it an attractive candidate for integration into electronic health records and longitudinal care pathways. Scores can help identify patients whose disease remains poorly controlled and who may warrant escalation of therapy, additional evaluation of comorbidities, or referral to specialized centers. In this video, Akin describes how systematic use of such instruments, in combination with thorough clinical interviewing, may improve the precision of symptom monitoring and provide a more reproducible framework for assessing response to emerging targeted therapies in ISM.

Videos

Video Series

KIT D816V Biology and Longitudinal Symptom Assessment in Indolent Systemic Mastocytosis

Keeping Pace with Advances in Gastroenterology, With Benjamin McDonald, MD, at UChicago Medicine

Inflammatory bowel disease (IBD) management increasingly requires clinicians to reconcile patient-reported symptoms with objective markers of inflammation, a dynamic that continues to evolve as diagnostic tools and therapeutic targets advance. Although symptom control remains central to patient care, contemporary practice recognizes that clinical remission does not always equate to mucosal healing. This distinction has meaningfully shifted how disease activity is monitored and how response to therapy is defined.

, a gastroenterologist specializing in inflammatory bowel diseases at 

, describes a multimodal approach to monitoring that integrates symptoms, biomarkers, imaging, and endoscopy. “How patients feel is the most important thing—it’s paramount,” McDonald said. “But we also know that many patients who feel well will continue to have ongoing inflammation, and it’s important to treat that too.” Rather than relying on a single metric, he advocates for longitudinal assessment using complementary tools, including biomarkers and imaging modalities alongside periodic endoscopic evaluation.

The treat-to-target paradigm, long embedded in IBD care, has further refined how clinicians assess therapeutic response. While the overarching goals—clinical remission and mucosal healing—remain consistent, McDonald noted that the field has shifted away from heavy reliance on endoscopy alone. Greater emphasis is now placed on noninvasive strategies, including stool-based testing and imaging, which may offer more patient-friendly monitoring while still aligning with guideline-directed targets. However, gaps remain between controlled trial environments and real-world populations, particularly given differences in disease severity and comorbid conditions.

Noninvasive biomarkers such as fecal calprotectin and C-reactive protein (CRP) are widely used, yet discordance between laboratory findings, symptoms, and endoscopic results is common. “There isn’t a perfect test,” McDonald said. In cases of discrepancy, he often seeks additional clarification through more targeted evaluation—frequently endoscopy or ultrasound—to better define inflammatory burden before adjusting therapy.

Endoscopic healing continues to serve as a central trial endpoint, but McDonald emphasized that translating trial-defined outcomes into meaningful, sustained benefit for patients requires individualized interpretation. As monitoring strategies become more nuanced, integrating objective inflammation control with patient-centered outcomes remains the cornerstone of effective IBD care.

Discover how intestinal ultrasound and biomarkers help spot hidden IBD inflammation, guiding faster treat-to-target decisions beyond endoscopy.

Introduction to ISM with emphasis on evolving clinical perception, disease heterogeneity, and persistent unmet needs despite conventional symptomatic therapy.

Indolent systemic mastocytosis (ISM) has historically been labeled a “benign” hematologic disorder on the basis of life expectancy, yet contemporary clinical experience underscores its substantial impact on morbidity and quality of life. Traditional classifications divided mastocytosis into benign and malignant variants according to survival, placing ISM in the former category and advanced systemic mastocytosis, including aggressive forms and those associated with other myeloid neoplasms, in the latter. Clinicians now recognize that many patients with ISM experience disabling multisystem symptoms that are disproportionate to the ostensibly indolent natural history of the disease and that the “benign” designation can be misleading from a patient-centered standpoint.

Disease expression in ISM is heterogeneous, ranging from asymptomatic individuals requiring only intermittent medications to patients with severe, refractory symptomatology despite optimized anti–mast cell mediator regimens. Conventional symptomatic approaches—primarily H1 and H2 antihistamines, leukotriene antagonists, and mast cell stabilizers—may attenuate mediator-related symptoms such as flushing and pruritus but do not alter the underlying mast cell burden. Visible cutaneous lesions often persist, contributing to psychosocial distress, and patients may be exposed to polypharmacy, with attendant adverse effects including sedation, weight gain, and fatigue. In addition, systemic complications such as recurrent anaphylaxis and osteoporosis with pathologic fractures remain important sources of morbidity and represent clear areas of unmet need.

Within this context, newer therapies targeting the KIT D816V driver mutation have begun to change the therapeutic landscape for ISM, particularly for patients whose symptoms remain uncontrolled with best available supportive care. These agents directly address the clonal mast cell compartment by reducing the burden of mutated cells, thereby offering the possibility of more profound and durable symptom relief. In this video discussion, Cem Akin, MD, reviews how the evolving understanding of ISM biology, coupled with the advent of selective KIT inhibition, has reframed both disease perception and treatment goals for patients with indolent systemic mastocytosis. Akin emphasizes the need to move beyond a purely “benign vs malignant” framework toward a model that incorporates quality of life, comorbidity burden, and long-term disease management.

1 Reframing “Benign” Disease: The Modern Clinical Impact of Indolent Systemic Mastocytosis

Maya Clark Cutaia, PhD, RN, is the inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at the Hunter-Bellevue School of Nursing at Hunter College.

Neighborhood Disadvantage As a Clinical Variable For Kidney Care, With Maya Clark Cutaia, PhD, RN

Considering neighborhood disadvantage as a clinical variable may be a useful strategy for supporting populations with reduced socioeconomic status in their kidney health, especially 

Lifelong exposure to adverse conditions within disadvantaged neighborhoods has been associated with an increased risk for kidney disease, along with accelerated progression. Despite this population’s adverse clinical outcomes, including progression to end-stage kidney disease, many needs remain unmet.

“In kidney disease, it looks like individuals who have higher exposure to environmental stressors,” said Maya Clark Cutaia, PhD, RN, the inaugural Evelyn Lauder Associate Dean for Nurse Practitioner Programs and Professor at the Hunter-Bellevue School of Nursing at Hunter College, in an interview with 

 “That may be things like pollution and heat, which we're seeing a lot nowadays, when, you know, focusing on climate work, fewer safe spaces so there's an inability to exercise, there's less reliability for access to healthy food and transportation, and then there's just a litany of other barriers that make it difficult for patients to get to primary care or nephrology care, and so it increases their risk, and therefore can accelerate their progression.”

Patients with kidney failure living in disadvantaged neighborhoods face barriers to care. Recent research has reported an association with neighborhood disadvantage and access to waitlisting and kidney transplantation. Furthermore, other evidence stated for > 1 in 10 of the most disadvantaged communities (11.7%) lacked a dialysis facility within a 30-minute drive compared with roughly 1 in 40 of the least disadvantaged communities (2.3%).

Even before patients reach ESKD, there may be missed opportunities for identifying CKD in its earlier stages and to intervene sooner, an aspect especially heightened in this patient population because of the aforementioned barriers to care.

“When we think about neighborhood disadvantage, it does mean there are differences in screening and CKD development or acknowledgement, diagnosis and management, suggesting that there are missed opportunities happening way downstream. It's a difficult conundrum because we're often seeing them being diagnosed at a point when complications already exist, and so our window for intervention is smaller.”

Surachman A. Neighborhood Deprivation, Financial Hardship, and Decrements in Kidney Function Across a Decade. 

https://doi.org/10.1093/geroni/igaf122.4413

Li Y, Menon G, Kim B, et al. Residential Neighborhood Disadvantage and Access to Kidney Transplantation. 

https://doi.org/10.1001/jamanetworkopen.2025.49679

Eisenbeisz ME, Chertow GM. Diminished Access to Dialysis in Disadvantaged Communities—Driving Toward More Equitable Care. 

. Published online February 23, 2026. doi:

https://doi.org/10.1001/jamainternmed.2025.8037

Should clinicians consider neighborhood disadvantage the same way they measure proteinuria and GFR for kidney health?

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

Following the release of new results from the phase 3 ADorable-1 trial on lebrikizumab in pediatric patients, Amy Paller, MD, speaks in a new Q&A interview.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Significance of ADorable-1 Data on Lebrikizumab in Children with Atopic Dermatitis, With Amy Paller, MD

Viet Le, DMSc, PA-C, is a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology.

Le discusses the AHA/ACC clinical guidelines for the management of dyslipidemia, highlighting the return of LDL-C target goals for ASCVD prevention.

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...

Dyslipidemia

Atherosclerotic Cardiovascular Disease

Strategic Alliance Partnership

AHA/ACC Dyslipidemia Guidelines Reinstate LDL-C Goals, With Viet Le, DMSc, PA-C

Désirée Larenas-Linnemann, MD, from Hospital Médica Sur

High costs, limited insurance coverage, and adherence challenges remain key barriers to broader SLIT use in the US, Larenas-Linnemann says in an interview at AAAAI 2026.

Conference

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

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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.

Barriers to Using SLIT, With Désirée Larenas-Linnemann, MD

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.

KDIGO Launches Focused Update to 2024 CKD Guideline on Emerging Therapies


Allocating lower but acceptable quality kidneys to high-risk patients could introduce equity. 

Expanding Use of Lower-Quality Kidneys Could Boost Transplants, Improve Equity, With Matthew Kaufmann, PhD

Natasha Mesinkovska, MD, PhD, is a dermatologist and researcher at the University of California, Irvine School of Medicine Department of Dermatology.

This segment of the latest episode of The Medical Sisterhood highlights insights into the career of Natasha Mesinkovska, MD, PhD.

Resilience, Rejection, and Recognition in Academic Dermatology

Nicole Ramsey, MD, PhD, assistant professor of pediatrics in the division of pediatric allergy and immunology at the Icahn School of Medicine at Mount Sinai.

At AAAAI 2026, Ramsey discussed the shift toward race-neutral spirometry equations, their clinical implications, and barriers to widespread adoption.

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.

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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.

Lung Cancer

Race-Neutral Spirometry Gains Support as Standard Practice, With Nicole Ramsey, MD, PhD

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 FDA has issued its third CRL to topical ocular reproxalap for the treatment of signs and symptoms of dry eye disease.

Ophthalmology

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FDA Issues Third Reproxalap CRL for Dry Eye Disease

Martinez and Harper outline practical workflows for initiating and titrating cardiac myosin inhibitors, emphasizing multidisciplinary team structure, telemedicine, and logistics around REMS and imaging.

Implementing Cardiac Myosin Inhibitors in oHCM: Workflow and Team-Based Care

Martinez and Harper describe a hub-and-spoke model for HCM care, follow-up cadence, and a structured “4-pillar” framework for longitudinal management, including imaging, biomarkers, and family-based risk strategies.



Latest News

Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

KIT D816V Biology and Longitudinal Symptom Assessment in Indolent Systemic Mastocytosis

Keeping Pace with Advances in Gastroenterology, With Benjamin McDonald, MD, at UChicago Medicine

1 Reframing “Benign” Disease: The Modern Clinical Impact of Indolent Systemic Mastocytosis

Neighborhood Disadvantage As a Clinical Variable For Kidney Care, With Maya Clark Cutaia, PhD, RN