Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing.
Several treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.
The primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.

Start Date13 Mar 2025

Sponsor / Collaborator

Yale University

[+1]

NCT06563323

/ Not yet recruitingPhase 2IIT

A Single-arm Open-label Study Assessing Short-term (Week 6, 16) and Long-term (Week 32) Efficacy of Guselkumab in Adult Participants With Pyoderma Gangrenosum

A single-arm open-label study assessing short-term (week 6, 16) and long-term (week 32) efficacy of guselkumab in adult participants with pyoderma gangrenosum (PG)

Start Date01 Jan 2025

Sponsor / Collaborator

Oregon Health & Science University

[+2]

NCT06586281

/ RecruitingNot ApplicableIIT

Elucidating Shared Mechanisms Contributing to Non-Alcoholic Fatty Liver Disease (NAFLD) and Psoriatic Arthritis (PsA) Disease Severity With Guselkumab Therapy

While many studies examine Nonalcoholic fatty liver disease (NAFLD), little is known about its progression to high-risk nonalcoholic steatohepatitis (NASH) in PsA patients. Shared disease mechanisms may explain the increased severity in PsA. This study involves two visits from PsA patients with NAFLD and active disease signs (e.g., swollen joint, enthesitis, or psoriatic plaque). It aims to assess the impact of biological therapies on liver disorders, joints, and skin in PsA patients.

Start Date01 Jan 2025

Sponsor / Collaborator

University of California San Diego

[+1]

100 Clinical Results associated with Guselkumab

100 Translational Medicine associated with Guselkumab

100 Patents (Medical) associated with Guselkumab

754

Literatures (Medical) associated with Guselkumab

01 Dec 2025·IMMUNOLOGIC RESEARCH

Residual non-specific and disease-specific inflammatory markers in successfully treated young psoriasis patients: a cross-sectional study

Article

Author: Kraner Šumenjak, Tadeja ; Merzel Šabović, Eva Klara ; Božič Mijovski, Mojca ; Janić, Miodrag

Abstract:

Psoriasis is a chronic, immune-mediated disease. The systemic inflammation triggered by psoriasis contributes significantly to increased cardiovascular risk. While various treatments completely clear the skin, the associated effects on systemic inflammation are not yet clear. We investigated residual systemic inflammation in successfully treated patients. Circulating disease-specific and non-specific inflammatory markers were measured and compared in 80 psoriasis patients (aged 30–45 years) successfully treated with topical therapy, methotrexate, adalimumab, secukinumab or guselkumab, and in 20 healthy controls. Non-specific inflammatory markers (high-sensitivity C-reactive protein (hs-CRP), complete blood count (CBC) parameters, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), mean platelet volume-to-platelet ratio (MPR), and red blood cell distribution width-to-platelet ratio (RPR)) and disease-specific inflammatory markers (interferon-γ (IFN-γ), tumor necrosis factor (TNF), interleukin (IL)-1β, IL-12p70, IL-17, and IL-23) were measured and compared between groups. Disease-specific cytokines (IFN-γ, TNF, IL-1β, IL-12p70, and IL-17, but not IL-23), were significantly elevated in patients compared to controls, while non-specific inflammatory markers showed no differences compared to controls. The residual disease-specific cytokines were similarly elevated in all five treated groups. In addition, they correlated significantly with body mass index (BMI) and waist circumference. Our results suggest that psoriasis patients have elevated residual disease-specific cytokines despite successful treatment, while the non-specific inflammatory markers are similar to those in control subjects. Residual disease-specific inflammatory markers correlated with BMI and waist circumference. A possible beneficial effect of body weight control in psoriasis patients merits further investigation. The study was registered at http://clinicaltrials.gov (identifier: NCT05957120) on July 24, 2023.

01 Mar 2025·JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY

Persistence of advanced systemic pharmacological treatment of moderate‐to‐severe psoriasis among bio‐naïve patients—A retrospective register‐based cohort study in Finland and Sweden

Article

Author: Passey, A. ; Wennerström, C. ; Johnsson, I. ; Hoti, F. ; Mälkönen, T. ; Katus, U. ; Hermanrud, C. ; Westerlund, A. ; Sveide, I. ; Hassan, F. ; Polesie, S. ; Tskhvarashvili, G. ; Saarelainen, L. ; Aher, K. ; Lee, J. ; Nissinen, R.

Abstract:

Background:

Plaque psoriasis (PsO) requires long‐term treatment for symptom control and remission; thus, a long‐term pharmacological intervention is necessary. Treatment persistence reflects long‐term therapeutic effectiveness and tolerance.

Objectives:

This study investigates drug persistence and compares treatment discontinuation rates across biologic agents and apremilast used by PsO patients in Finland and Sweden.

Methods:

This retrospective register‐based cohort study included bio‐naïve patients (≥18 years) with moderate‐to‐severe PsO, who initiated treatment with abatacept, adalimumab, brodalumab, certolizumab pegol, etanercept, golimumab, guselkumab, ixekizumab, risankizumab, secukinumab, tildrakizumab, ustekinumab or apremilast during 2008–2020 in Finland or Sweden. The main analysis evaluated persistence (based on duration of continuous treatment) and compared rates of treatment discontinuation using guselkumab as reference drug, during 2018–2020 in Finland. Treatment discontinuation was assessed by survival analysis of the time to first drug discontinuation, including switching to other study drugs. Due to limited sample size (n < 20), certain biologics (abatacept, brodalumab, certolizumab pegol, etanercept, golimumab, risankizumab and tildrakizumab) were excluded from the persistence analysis.

Results:

In Finland, 709 patients fulfilled the inclusion criteria during 2018–2020 for the main analysis. The highest persistence was observed for guselkumab and ustekinumab with 90 and 85% of treated patients, respectively, continuing treatment for ≥1 year. Comparable results were observed in the expanded cohort analysis (index starting in 2008; 2745 bio‐naïve patients in Finland and 10,970 in Sweden). Furthermore, patients treated with guselkumab in Finland showed lower treatment discontinuation rates compared to other study drugs.

Conclusion:

Guselkumab and ustekinumab demonstrated high persistence as measured by continued treatment for at least 1 year. Furthermore, these treatments demonstrated lower rates of discontinuation compared to other study drugs included in the analysis. Understanding the balance between efficacy and feasibility in treatment decisions is crucial, as feasibility may impact persistency outcomes and potentially increase persistency rates.

01 Mar 2025·AMERICAN JOURNAL OF CLINICAL DERMATOLOGY

The Impact of Family History on Clinical Presentation and Biologic Treatment Response in Patients with Psoriasis: A Multicenter Prospective Cohort Study

Article

Author: Zhong, Xiaoyuan ; Shi, Yuling ; Wang, Yu ; Liu, Xiaoke ; Ma, Rui ; Yao, Lingling ; Jiang, Yuxiong ; Huang, Dawei ; Lu, Jiajing ; Li, Ying ; Zhang, Xilin ; Xu, Shuang

BACKGROUND:

Family history (FH) of psoriasis has been implicated as a risk factor for developing psoriasis. However, whether FH also carries information on clinical presentation and treatment response to biological agents in patients with psoriasis remains unclear.

OBJECTIVE:

This prospective, multicenter observational study aimed to analyze the clinical presentation and efficacy differences between patients with psoriasis with and without a FH.

PATIENTS AND METHODS:

The SPEECH registry is an observational, multicenter, and prospective registry that has been collecting data on psoriasis treatment since November 2022. This study included adult patients diagnosed with moderate-to-severe plaque psoriasis initiating treatment with biologics, including guselkumab, secukinumab, ixekizumab, ustekinumab, and adalimumab. FH of psoriasis was identified through patient self-report in which a positive FH was defined as a first-degree relative having psoriasis. The primary outcome measures include 75% improvement in Psoriasis Area and Severity Index (PASI75) and the Physician's Global Assessment score of cleared/minimal (PGA 0/1) after 3 months of treatment. Logistic regression was employed to determine the adjusted odds ratios (aOR) and 95% confidence intervals (CI) for the achievement of response in selected outcomes for patients with a FH compared with those without a FH.

RESULTS:

The study included a total of 859 patients, of whom 22.9% had a FH of psoriasis. Patients with psoriasis who had a FH experienced an earlier onset of the disease and more severe anxiety symptoms than those without a FH. After 3 months of treatment, patients with psoriasis with a FH exhibited a higher likelihood of achieving PASI75 (aOR 1.60 [95% CI 1.02, 2.51]) and PGA 0/1 (aOR 1.54 [95% CI 1.03, 2.31]). Notably, these differences persisted after 6 months of treatment, confirming the sustained effectiveness of biologic treatments in patients with a positive FH. Further mediation analysis uncovered a significant indirect effect of FH on the treatment response to biologics through age of onset (p = 0.028), and the proportion mediated was 20.5%.

CONCLUSION:

FH of psoriasis may affect the clinical course of patients and enhance their treatment response to biologics, highlighting the importance of FH assessment in optimizing treatment outcome and guiding clinical decision of biologic selection. Future studies on biologic treatment responses in psoriasis should consider family history as a significant confounding factor.

CHINESE CLINICAL TRIAL REGISTRY:

ChiCTR2000036186.

222

News (Medical) associated with Guselkumab

12 Mar 2025

·www.prnewswire.com

Psoriatic Arthritis Market Sees Major Shift with Growing Biosimilar Adoption | DelveInsight

The arrival of biosimilars like Celltrion's STEQEYMA and Biocon's YESINTEK is shaking up the psoriatic arthritis market, challenging blockbuster biologics with cost-effective alternatives. As competition intensifies, these biosimilars are reshaping treatment choices and driving a shift in the market landscape. LAS VEGAS, March 12, 2025 /PRNewswire/ -- Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects approximately 112 per 100,000 adults worldwide. It is more prevalent in Europe and North America than in Asia and South America. In patients with psoriasis, the prevalence of psoriatic arthritis can range from 6% to 34% in Western populations. Despite its impact, many individuals with psoriatic arthritis remain undiagnosed or receive inadequate treatment, highlighting the need for increased awareness and access to specialized care. As per DelveInsight analysis, among the 7MM, the United States accounted for the highest number of prevalent cases of psoriatic arthritis in 2023, and these cases are expected to increase by the end of 2034 due to several key factors such as an increase in awareness and diagnosis, as well as the rapid prevalence of PsA. Psoriatic arthritis, occurring in approximately 20% of individuals with psoriasis, is a chronic inflammatory arthritis intricately linked to psoriatic arthritis. This aggressive condition is characterized by potential significant morbidity and compromised quality of life. Treatment approaches for psoriatic arthritis encompass a variety of strategies aimed at managing symptoms, slowing disease progression, and improving the overall quality of life. These approaches typically involve a combination of pharmacological therapies, lifestyle modifications, and, in severe cases, surgical interventions. Psoriatic arthritis treatment is highly individualized based on disease severity, response to therapy, and patient preferences, with multidisciplinary care from rheumatologists, dermatologists, and physical therapists playing a key role. Pharmacological treatment for psoriatic arthritis primarily targets inflammation and pain relief. Nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, are often the first line of defense, helping to reduce pain and inflammation. Disease-modifying antirheumatic drugs (DMARDs) like methotrexate, sulfasalazine, and leflunomide are commonly prescribed to prevent joint damage and suppress the inflammatory process. For individuals with mild-to-moderate psoriatic arthritis, oral small molecules (OSMs) like OTEZLA (apremilast) offer a convenient, non-injectable option by modulating inflammatory pathways. Biologic agents have revolutionized the treatment landscape for psoriatic arthritis. These medications specifically inhibit key molecules in the inflammatory cascade. TNF inhibitors like HUMIRA (adalimumab), ENBREL (etanercept), and REMICADE (infliximab) are frontline biologics that target tumor necrosis factor, a crucial driver of inflammation. Patients who do not respond to TNF inhibitors may benefit from IL-17 inhibitors like COSENTYX (secukinumab) and TALTZ (ixekizumab) or IL-12/23 inhibitors such as STELARA (ustekinumab). Learn more about the FDA-approved psoriatic arthritis drugs @ Drugs for Psoriatic Arthritis Treatment SKYRIZI (risankizumab), developed by AbbVie, is a humanized IgG1 monoclonal antibody that acts as an interleukin-23 (IL-23) antagonist. It can be used on its own or in conjunction with non-biologic DMARDs. In June 2022, the FDA approved SKYRIZI as the first and only targeted IL-23 inhibitor for adults with active psoriatic arthritis. Another biologic, TREMFYA (guselkumab by Janssen), was approved by the FDA in July 2020 as the first monoclonal antibody that selectively binds to the p19 subunit of IL-23, further expanding treatment options for psoriatic arthritis patients. BIMZELX (bimekizumab), developed by UCB Biopharma, is a humanized monoclonal antibody that targets IL-17A and IL-17F. It received European Commission approval in June 2023 for adults with active psoriatic arthritis and axial spondyloarthritis. On September 23, 2024, the FDA approved BIMZELX for treating adults with active psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA) with objective inflammation, and active ankylosing spondylitis. In Phase III studies, BIMZELX showed meaningful responses in patients with inadequate TNF inhibitor responses and those new to biologics, indicating its potential as an important treatment option for psoriatic arthritis. In cases where joint damage becomes severe and unresponsive to medical therapies, surgical interventions like joint replacement surgery may be necessary to restore function and alleviate pain. Lifestyle changes, such as regular exercise, joint protection techniques, and weight management, are also critical in managing psoriatic arthritis, as excess weight can worsen symptoms and increase disease severity. The treatment landscape for psoriatic arthritis continues to evolve, offering hope to patients with more targeted therapies and improved outcomes. As companies like UCB Biopharma, AbbVie, and Janssen advance their biologic portfolios, the future looks promising for psoriatic arthritis management. The competition in the biosimilar market is intensifying as companies introduce cost-effective alternatives to blockbuster biologics. In December 2024, Celltrion announced FDA approval for STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Simultaneously, Biocon Biologics Ltd. is strengthening its position with positive Phase III results for YESINTEK, its biosimilar to ustekinumab, in adult patients with moderate to severe chronic plaque psoriasis. The pivotal randomized, double-blind, parallel-group study demonstrated comparable efficacy and safety to the reference biologic, STELARA, and the findings are being presented at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida. With the approval of STEQEYMA and the promising clinical outcomes for YESINTEK, these biosimilars are poised to challenge STELARA by offering cost-effective alternatives in key immunology indications. As pricing pressures and healthcare sustainability concerns drive the demand for biosimilars, these developments mark a significant shift in the treatment landscape, providing greater accessibility and affordability for patients while increasing competition in the immunology market. To know more about psoriatic arthritis treatment options, visit @ New Treatment for Psoriatic Arthritis The psoriatic arthritis market is buzzing with numerous companies advancing treatments to cater to the growing patient base. Several therapies are expected to enter the market during the forecast period, providing new hope for patients. Some of these potential therapies include ACELYRIN Inc.'s Izokibep, Novartis Pharmaceuticals' Secukinumab, UCB Biopharma SRL's Bimekizumab, and Bristol-Myers Squibb's Deucravacitinib. Additionally, AbbVie's Upadacitinib and Risankizumab, as well as Eli Lilly and Company's Ixekizumab, are also part of the promising pipeline. Other noteworthy therapies include Sun Pharma's ILUMYA/ILUMETRI, Bristol-Myers Squibb's SOTYKTU, and Affibody's Izokibep in collaboration with Acelyrin and Inmagene. With these advancements, the psoriatic arthritis treatment landscape is set for a major shift, offering patients more tailored and effective options. The companies involved in developing biosimilars include Alvotech, Teva, Biocon Biologics, Celltrion, Fresenius Kabi, and others. Discover which therapies are expected to grab major psoriatic arthritis market share @ Psoriatic Arthritis Market Report ILUMYA/ILUMETRI by Sun Pharma is an interleukin-23 (IL-23) inhibitor classified as a humanized, anti-IL-23p19 monoclonal antibody. It works by blocking inflammatory proteins (cytokines and chemokines) in the body. By inhibiting the effects of IL-23, ILUMYA helps control the release of other inflammatory proteins, including IL-17 and TNF-α. This mechanism reduces inflammation, decreases the number of inflammatory cells in psoriatic lesions, helps prevent plaque formation, and resolves tissue damage. The drug is currently undergoing evaluation in Phase III clinical development, actively recruiting subjects with active psoriatic arthritis who have prior exposure to anti-TNF agents, as well as those who are anti-TNF naïve. SOTYKTU, developed by Bristol-Myers Squibb, is the first and only novel oral selective tyrosine kinase 2 (TYK2) inhibitor being studied across multiple immune-mediated diseases. Deucravacitinib binds to the regulatory domain of the TYK2 enzyme, inhibiting its activation. This selective inhibition reduces the release of proinflammatory cytokines and chemokines, helping to control the inflammation associated with psoriatic arthritis and alleviating its signs and symptoms. Currently, the drug is being investigated for the treatment of psoriatic arthritis in a Phase III clinical trial. Izokibep, developed by Affibody in partnership with Acelyrin and Inmagene, is a unique antibody mimetic and a novel bispecific agent that potentially targets both subunits of the IL-17A homo-dimer and serum albumin. Affibody has entered into a partnership agreement with Acelyrin for the development and commercialization of izokibep and has completed a Phase II trial. As part of this agreement, Acelyrin obtained worldwide rights to izokibep, excluding selected Asian countries, where rights have been granted to Inmagene Biopharmaceuticals. In March 2024, Acelyrin announced the release of positive top-line results from the Phase IIb/III trial, indicating that izokibep was well-tolerated with a favorable safety profile. This drug is currently in Phase III clinical trial. Discover more about drugs for psoriatic arthritis in development @ Psoriatic Arthritis Clinical Trials The anticipated launch of these emerging therapies for psoriatic arthritis is poised to transform the market landscape in the coming years. As these cutting-edge treatments continue to mature and gain regulatory approval, they are expected to reshape the psoriatic arthritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the psoriatic arthritis market size was USD 9 billion in 2021 and is expected to grow significantly in the coming years. This growth can be attributed to the introduction of upcoming therapies and the rising prevalence of the condition. The anticipated launch of these therapies is also expected to attract new entrants to the psoriatic arthritis market, resulting in increased competition and innovation. DelveInsight's latest published market report titled " Psoriatic Arthritis Market Insight, Epidemiology, and Market Forecast – 2034" will help you discover which market leader is set to capture the largest market share. The report provides comprehensive insights into country-specific treatment guidelines, patient pool analysis, and epidemiology forecasts to help understand key opportunities and assess the market's underlying potential. The psoriatic arthritis market report offers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Prevalent Cases of Psoriatic Arthritis Total Diagnosed Prevalent Cases of Psoriatic Arthritis Gender-specific Diagnosed Prevalent Cases of Psoriatic Arthritis Severity-specific Diagnosed Prevalent Cases of Psoriatic Arthritis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM Psoriatic Arthritis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this psoriatic arthritis market report to assess the epidemiology forecasts, understand patient journeys, gain insights into KOLs' opinions about upcoming treatment paradigms, and identify the factors contributing to changes in the psoriatic arthritis market. Additionally, stay informed about the mitigating factors that can enhance your market position in the psoriatic arthritis therapeutic space. Related Reports Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key schizophrenia companies, including Affibody, Kymera, Selection Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, ACELYRIN Inc., among others. Psoriatic Arthritis Epidemiology Forecast Psoriatic Arthritis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Psoriatic Arthritis epidemiology trends. Ankylosing Spondylitis Market Ankylosing Spondylitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Ankylosing Spondylitis companies, including UCB, AbbVie, Pfizer, Astella, Amgen, Janssen Biotech, Pozen, Novartis, Iroko Pharmaceuticals, Syntex Pharmaceuticals, Horizon Pharma, Eli Lilly and Company, among others. Psoriasis Market Psoriasis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Psoriasis companies, including Amgen, Janssen, Abbvie, Novartis, AstraZeneca, Bausch Health, Eli Lilly, Sun Pharmaceutical, Janssen Biotech, UCB Inc., LEO Pharma, Promius Pharma, Mayne Pharma, Bausch Health Companies, MC2 Therapeutics, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalClinical ResultPhase 2

10 Mar 2025

·www.fiercebiotech.com

J&J, Protagonist\'s oral psoriasis prospect bests BMS\' Sotyktu in pair of phase 3 trials

Based on clinical successes, Johnson & Johnson wants to see how icotrokinra fares against its own med Stelara.\n Johnson & Johnson’s once-daily oral peptide has bested Bristol Myers Squibb’s reigning oral psoriasis med Sotyktu in a pair of phase 3 trials.The Protagonist Therapeutics-partnered IL-23 inhibitor, called icotrokinra, hit the co-primary endpoints of the late-stage studies, which required at least a 2-grade improvement in plaque psoriasis at week 16 compared to placebo.But it was the study’s secondary endpoints that gave a sense of icotrokinra’s potential to shake up the psoriasis space. Here, icotrokinra showed its superiority to Sotyktu at reducing the severity of psoriasis and size of lesions at weeks 16 and 24.J&J made the announcement as part of its presentations at the American Academy of Dermatalogy\'s annual meeting, which runs March 7-11. While the Big Pharma didn’t drill down into the data for the Iconic-Advance 1&2 studies, the company did use the conference to reinforce the findings from a previous phase 3 plaque psoriasis win for icotrokinra in the Iconic-Lead study. J&J reported back in November that Iconic-Lead had shown that 64.7% of icotrokinra-treated patients achieved clear or almost clear skin compared to placebo’s 8.3% at week 16. Meanwhile, 49.6% of patients saw a 90% or more improvement in their Psoriasis Area and Severity Index score compared to 4.4% of those on placebo.Summarizing the results from all three trials, J&J said icotrokinra had proven that its “standout combination of complete skin clearance and favorable safety profile in a once daily pill could shift [the] treatment paradigm” for psoriasis.“The robust results seen to date underscore the potential for icotrokinra to shift treatment expectations in moderate-to-severe plaque psoriasis,” Liza O\'Dowd, vice president and immunodermatology disease area lead for Johnson & Johnson Innovative Medicine, said in the March 8 release.“As part of our ongoing commitment to pioneer innovations for patients, we are proud to advance this first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which shows promise as a potential first-line systemic therapy for the treatment of plaque psoriasis,” O’Dowd added.Based on these clinical successes, J&J now wants to see how icotrokinra fares against its own med Stelara, which is approved for psoriasis among other inflammatory conditions. To this end, the company will launch the phase 3 Iconic-Ascend study, which the pharma is already describing as the “first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic in moderate-to-severe plaque psoriasis.”Assessing the weekend\'s readouts, Leerink analysts said they view icotrokinra “primarily as an ‘IL-23 market expander.’”“It is still somewhat unclear to what degree patients will prefer a once-daily oral pill with food restrictions (patients can’t consume anything other than water for 30 minutes after taking their daily pill) relative to quarterly Skyrizi maintenance dosing,” the analysts added in a March 10 note.The clinical wins didn\'t end with psoriasis either. Monday morning, J&J also announced that icotrokinra had hit the primary endpoint of a phase 2 study in ulcerative colitis. All three doses of the drug demonstrated a clinical response at week 12, with a 63.5% response rate for the highest dose compared to 27% for the placebo cohort.J&J touts icotrokinra, which was born out of a 2017 collaboration with Protagonist, as the first oral peptide designed to selectively block IL-23. The stakes have been high for the drug, bearing in mind the competitive arena of IL-23 blockers and J&J\'s previous success in injectable contenders. While icotrokinra proved it could improve outcomes in phase 2 studies, the results didn’t quite live up to what J&J had seen during the phase 3 tests of its blockbuster injectable anti-IL-23 blocker Tremfya.Still, the convenience of an oral delivery has meant that analysts had continued to argue that icotrokinra could be a serious competitor to BMS\' Sotyktu.

$J&J, Protagonist\'s oral psoriasis prospect bests BMS\' Sotyktu in pair of phase 3 trials$

Clinical ResultPhase 3Phase 2

10 Mar 2025

·firstwordpharma.com

J&J's oral IL-23 peptide icotrokinra delivers in UC after psoriasis triumph

Johnson & Johnson's icotrokinra (JNJ-2113) met the primary endpoint of a Phase IIb ulcerative colitis (UC) study, building on its recent success in psoriasis. The IL-23-blocking oral peptide could also boost the company's efforts to stay ahead in immunology as Stelara (ustekinumab) stares down biosimilar competition.In the ANTHEM-UC study, J&J tested three once-daily doses of icotrokinra and found that the highest one led to a clinical response in 63.5% of patients after 12 weeks, compared to just 27% for placebo. The drug also showed "meaningful differences" on secondary measures like clinical remission, with 30.2% of patients on the highest dose achieving remission versus 11.1% for placebo. J&J said the benefits kept improving through week 28, with a favourable safety profile.The trial enrolled 252 patients with moderately to severely active UC who'd had an inadequate response or intolerance to conventional therapy. More ANTHEM-UC results will be shared at upcoming medical congresses."These impressive findings show the potential of icotrokinra to transform the treatment paradigm… by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment," said Esi Lamousé-Smith, gastroenterology disease area lead at J&J, in a release Monday.The icotrokinra results complement J&J's recent efforts to strengthen its IL-23 lineup, including September's FDA approval of Tremfya (guselkumab) for UC with intravenous induction and subcutaneous maintenance, and a pending application for a fully subcutaneous regimen. According to data presented last month, Tremfya's SC induction demonstrated significantly higher rates of clinical remission (27.6% vs 6.5%) and response (65.6% vs 34.5%) versus placebo at week 12 in the Phase III ASTRO trial.Both icotrokinra and Tremfya are being positioned to help offset expected revenue declines from Stelara, which saw a 4.6% global sales drop in 2024 as biosimilars enter the market.The UC data for icotrokinra follows its strong showing in psoriasis at the American Academy of Dermatology (AAD) meeting over the weekend. The ICONIC-ADVANCE 1 and 2 trials not only met their primary endpoints of achieving clear or nearly clear skin, but also demonstrated superiority to Bristol Myers Squibb's oral TYK2 inhibitor Sotyktu (deucravacitinib). See – ViewPoints: AAD25 – J&J leadership tells how icotrokinra is upping the ante across the board in psoriasis.

Clinical ResultPhase 3Drug ApprovalPhase 2

100 Deals associated with Guselkumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10438	Guselkumab	L04AC16	DB11834

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn's disease, active moderate	China	Janssen-Cilag International NV	20 Feb 2025
Crohn's disease, active severe	China	Janssen-Cilag International NV	20 Feb 2025
Ulcerative colitis, active moderate	United States	Janssen Biotech, Inc.	11 Sep 2024
Ulcerative colitis, active severe	United States	Janssen Biotech, Inc.	11 Sep 2024
Erythrodermic psoriasis	Japan	Janssen Global Services LLC	23 Mar 2018
Psoriasis	Japan	Janssen Global Services LLC	23 Mar 2018
Pustular psoriasis	Japan	Janssen Global Services LLC	23 Mar 2018
Arthritis, Psoriatic	European Union	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Iceland	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Liechtenstein	Janssen-Cilag International NV	10 Nov 2017
Arthritis, Psoriatic	Norway	Janssen-Cilag International NV	10 Nov 2017
Plaque psoriasis	United States	Janssen Biotech, Inc.	13 Jul 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Juvenile Idiopathic Arthritis	NDA/BLA	United States	Johnson & Johnson	02 Dec 2024
Crohn Disease	NDA/BLA	China	Xian-Janssen Pharmaceutical Ltd.	06 Mar 2024
Pediatric Crohn's Disease	Phase 3	United States	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Japan	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Austria	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Belgium	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Brazil	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	France	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Israel	Janssen Research & Development LLC	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	Italy	Janssen Research & Development LLC	13 Mar 2024

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05528510 (ASTRO, Company_Website 1 \| Company_Website 2) Manual	Phase 3	Colitis, Ulcerative	418	TREMFYA® 400 mg SC induction	kligtxbvwm(dqdrwxnbfh) = mqjmyebsfv upakdvesmh (mauqybtowf ) Met View more	Positive	21 Feb 2025
				Placebo	kligtxbvwm(dqdrwxnbfh) = zhranffhcv upakdvesmh (mauqybtowf ) Met View more
NCT05197049 (GRAVITI, CTgov)	Phase 3	Crohn Disease	350	placebo+guselkumab (Placebo)	fufvtyyfyq = rbfnrzegpk qiawvrmscm (frfdkaacvl, hgqpowppbj - vzcghfzzjz) View more	-	21 Feb 2025
				Guselkumab (Combined: Guselkumab 400 mg)	fufvtyyfyq = pulghkqwuj qiawvrmscm (frfdkaacvl, miucqsivys - jigayjnvwq) View more
NCT05125679 (G-CARE, CTgov)	Phase 4	Plaque psoriasis	15	Guselkumab (Guselkumab 100 mg: Nicotine Users)	gblmmnkuky(cxjnenxijf) = xjuouioegs cvmxsahxbg (ppvujygqgv, 0.2773) View more	-	27 Jan 2025
				Guselkumab (Guselkumab 100 mg: Non-Nicotine Users)	gblmmnkuky(cxjnenxijf) = lguzkpvunx cvmxsahxbg (ppvujygqgv, 0.6478) View more
NCT04033445 (QUASAR, Pubmed) Manual	Phase 3	Ulcerative colitis, active moderate \| Ulcerative colitis, active severe Induction \| Maintenance	-	guselkumab 200 mg (induction study)	ysksyrflmw(ecrbpjfejk) = vgsysngcgv bplqtdjygb (yeokjdieui ) View more	Positive	17 Dec 2024
				Placebo (induction study)	ysksyrflmw(ecrbpjfejk) = vwxlvwhhrk bplqtdjygb (yeokjdieui ) View more
NCT06039189 (SPECTREM, NEWS) Manual	Phase 3	Plaque psoriasis	-	Tremfya (guselkumab)	cxwxjypybe(teelvkylrr) = ahlkpbxfcg jfjmfnwxvz (hzukhjrvxv ) View more	Positive	31 Oct 2024
				Placebo	cxwxjypybe(teelvkylrr) = fkpimhinld jfjmfnwxvz (hzukhjrvxv ) View more
NCT05197049 (GRAVITI, Company_Website) Manual	Phase 3	Crohn Disease	-	TREMFYA® 400 mg SC q4w	ghkrnidkey(emtwjaeyne) = zjcsdnjmql xndmvdgnyw (edcacedngf ) View more	Positive	28 Oct 2024
				TREMFYA® 100 mg SC q8w	ghkrnidkey(wkgoiycbys) = gcubeaptpp scpuymbskq (lcykguwiic ) View more
NCT05784129 (PROGRESS, CTgov)	Phase 3	Crohn Disease	4	Guselkumab (Guselkumab 200 mg + Guselkumab 100 mg)	tgppddpave = xhttfjcmpe asxnmdbkmu (cvjqefwgcj, uwlrrzkzyk - hpjetvwtle) View more	-	28 Oct 2024
				placebo+guselkumab (Placebo)	tgppddpave = fuynvyqidj asxnmdbkmu (cvjqefwgcj, zcfvdwdcjc - brzesmrsoo) View more
UEGW2024	Not Applicable	Ulcerative colitis, active moderate	-	Guselkumab 200 mg SC q4w	qdvfuakufe(tkgpqwkrsy) = gnrezczvnq nmmfbaxktw (qxolcumcbz ) View more	-	13 Oct 2024
				Guselkumab 100 mg SC q8w	qdvfuakufe(tkgpqwkrsy) = nihzoqiykd nmmfbaxktw (qxolcumcbz )
NCT04033445 (QUASAR, UEGW2024)	Phase 3	Ulcerative colitis, active moderate Maintenance CD64	568	Guselkumab 200 mg SC q4w	ogbtwkviua(sopmabcnkp) = iyxotwvrup ggrkmdrokt (fnyasuprwi ) View more	Positive	13 Oct 2024
				Guselkumab 100 mg SC q8w	ogbtwkviua(sopmabcnkp) = qumvwapbvi ggrkmdrokt (fnyasuprwi ) View more
NCT04033445 (QUASAR Maintenance Study, UEGW2024)	Phase 3	Ulcerative colitis, active severe Maintenance	568	Guselkumab 200 mg SC q4w	ucuejfdxwk(aotyjszgdd) = ggsxkxuikn vcozylznyv (yvuwostnhm ) View more	Positive	13 Oct 2024
				Guselkumab 100 mg SC q8w	ucuejfdxwk(aotyjszgdd) = skjgfipfog vcozylznyv (yvuwostnhm ) View more

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