Latest news with #IL-23
Yahoo
22-07-2025
- Business
- Yahoo
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.1,2,3 The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.4,5,6,7,8 "The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease." Data submitted to the FDA as part of the NDA include: Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)e 90 compared to placebo at Week 16.4 A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.5 Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.6 Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.7,8 Comprehensive results are being prepared for presentation at a future medical meeting. Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting. Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.9 Editor's notes: a. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 12 years of age or older with moderate-to-severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients. b. ICONIC-TOTAL is a Phase 3 RCT evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. c. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. d. The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate and 4 indicates severe disease.10 e. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11 f. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.9 About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company.12 ICONIC-LEAD (NCT06095115) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints.13 ICONIC-TOTAL (NCT06095102) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint.14 Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.15,16 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 (NCT06878404) and ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.17,18 About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.19 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.20 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.20 Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales. Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.21 Living with plaque PsO can be a challenge and impact life beyond a person's physical health, including emotional health, relationships, and handling the stressors of life.22 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life.22,23 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,1 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.2,3 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells.24 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.25 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.26,27,28 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in active psoriatic arthritis; and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8.2 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229.3 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.4 Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23–Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.5 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.6 Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025.7 Data on file.8 Data on file.9 A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 2025.10 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/ Accessed July 2025.11 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: Accessed July 2025.12 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: Accessed July 2025.13 A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. Accessed July 2025.14 A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. Accessed July 2025.15 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed July 2025.16 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Accessed July 2025.17 A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. National Psoriasis Foundation. About Psoriasis. Available at: Accessed July 2025.20 National Psoriasis Foundation. Psoriasis Statistics. Available at: Accessed July 2025.21 National Psoriasis Foundation. Plaque Psoriasis. Available at: Accessed July 2025.22 National Psoriasis Foundation. Life with Psoriasis. Available at: Accessed July 2025.23 National Psoriasis Foundation. High Impact Sites. Available at: Accessed July 2025.24 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14.25 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: Accessed July 2025.26 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: Accessed July 2025.27 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: Accessed July 2025.28 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: Accessed July 2025. Media contact: Meg Farina mfarina@ Investor contact: Lauren Johnson investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
&w=3840&q=100)
Business Standard
21-07-2025
- Health
- Business Standard
Sun Pharma's ILUMYA delivers positive psoriatic arthritis trial results
Sun Pharmaceutical Industries has announced that its psoriasis drug ILUMYA (tildrakizumab 100 mg) delivered positive results in two late-stage clinical trials for active psoriatic arthritis (PsA), potentially paving the way for regulatory filings in the United States. The Phase 3 INSPIRE-1 and INSPIRE-2 studies evaluated the efficacy and safety of ILUMYA over a 24-week period. According to the company, both trials achieved statistically significant improvements in ACR20 response rates—a standard measure of arthritis treatment effectiveness—compared with placebo at Week 24. INSPIRE-1 included patients with prior exposure to anti-TNF therapies, while INSPIRE-2 focused on anti-TNF naïve patients. More than 800 adult participants were enrolled across clinical sites in the US, Europe, and Asia. ILUMYA was administered at Week 0 and every 12 weeks thereafter, with no induction dose. Consistent safety profile supports regulatory case Sun Pharma stated that the safety outcomes in the psoriatic arthritis trials were consistent with ILUMYA's established safety profile from earlier studies in plaque psoriasis. No new safety signals were identified. ILUMYA is currently approved in the US and other countries for the treatment of moderate-to-severe plaque psoriasis in adults. Its use in psoriatic arthritis remains investigational and has not yet been evaluated by regulatory authorities. Detailed results from the INSPIRE studies will be presented at upcoming medical conferences and submitted for publication in peer-reviewed journals. Targeting IL-23 in chronic inflammatory pathways ILUMYA is a monoclonal antibody that targets the p19 subunit of interleukin-23 (IL-23), thereby inhibiting inflammatory pathways associated with chronic autoimmune conditions. Common adverse reactions reported in previous studies include upper respiratory infections, injection-site reactions, and diarrhoea. The drug carries warnings related to hypersensitivity, infections, and tuberculosis risk. Psoriatic arthritis affects an estimated 2.4 million people in the United States. Approximately one-third of psoriasis patients may develop the joint condition, though many cases remain undiagnosed. Strategic pipeline strengthens global presence Sun Pharma is India's largest pharmaceutical company and one of the world's leading generic drug manufacturers. The company operates in over 100 countries and has a growing specialty portfolio in dermatology, ophthalmology, and onco-dermatology.
Associated Press
14-04-2025
- Business
- Associated Press
Johnson & Johnson's Oral IL-23, Icotrokinra, Poised to Redefine the Psoriasis Treatment Landscape Following Positive Phase 3 Data, According to Spherix Global Insights
EXTON, PA, April 14, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson's recent announcement of positive Phase 3 data for its oral IL-23 receptor antagonist, icotrokinra (JNJ-2113), has sparked notable enthusiasm across the dermatology community. According to the company's recent release, the once-daily oral therapy met all primary and secondary endpoints across both the FRONTIER 1 and FRONTIER 2 studies in moderate-to-severe plaque psoriasis, achieving 65% PASI 90 response and 74% IGA 0/1 at Week 24 with its higher dose regimen. These efficacy outcomes and a favorable safety profile suggest that icotrokinra may become the first oral IL-23 pathway inhibitor to reshape the current psoriasis treatment algorithm. Data from Spherix Global Insights' RealTime Dynamix™: Plaque Psoriasis (US) Q1 2025 report confirms heightened interest in icotrokinra among dermatologists (n=103), with many already envisioning its role as a first-line systemic treatment. While unaided awareness of the Phase 3 results was modest, prompted exposure to the data led to a significant uptick in prescriber enthusiasm. In fact, dermatologists rated icotrokinra as the top pipeline agent by a considerable margin, and they would like to see it approved, with interest and likelihood to prescribe scores surpassing all other late-stage psoriasis assets. Notably, over half of dermatologists reported that icotrokinra would be used as a first-line advanced systemic treatment. At the same time, most agree that its availability would expand the pool of psoriasis patients on advanced treatments—a strong indicator that icotrokinra may help bridge the gap between topical and biologic therapies. Importantly, a sizable portion of patients currently treated with oral small molecules (i.e., Otezla or Sotyktu) who are not considered well-managed may be switched to icotrokinra upon availability, underscoring its potential to disrupt the existing oral systemic market. Dermatologists cited its oral convenience, high response rates, and mechanistic familiarity with successful IL-23 biologics like Skyrizi and Tremfya as primary drivers of interest. Data from Spherix's Special Topix™: The Oral Opportunity in Plaque Psoriasis, 2024 study indicate that the availability of efficacious and safe oral agents is the top unmet need for treating psoriasis. Moreover, most dermatologists believe that oral treatment can be just as efficacious as injectable treatment. Despite the positive momentum, some prescribers remain cautiously optimistic, pointing to the need for real-world data and long-term safety monitoring before making widespread practice changes. However, with robust Phase 3 results and clear differentiation from existing oral therapies, icotrokinra is poised to be a game-changer in moderate-to-severe plaque psoriasis. As J&J advances icotrokinra toward regulatory submission, ongoing dermatologist perception tracking will be critical in determining its commercial potential and ultimate impact on the psoriasis landscape. Spherix continues to monitor the PsO market with these insights and more available via its quarterly RealTime Dynamix™ service, and will continuously evaluate the oral opportunities in psoriasis via the Special Topix™ service. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. Special Topix™ is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. Andy Stankus, Dermatology Franchise Head Spherix Global Insights 4848794284 [email protected]
Yahoo
14-04-2025
- Business
- Yahoo
Johnson & Johnson's Oral IL-23, Icotrokinra, Poised to Redefine the Psoriasis Treatment Landscape Following Positive Phase 3 Data, According to Spherix Global Insights
Perceived first-line utility, patient pool expansion, and paradigm-shifting potential distinguish Icotrokinra in the eyes of US dermatologists EXTON, PA, April 14, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson's recent announcement of positive Phase 3 data for its oral IL-23 receptor antagonist, icotrokinra (JNJ-2113), has sparked notable enthusiasm across the dermatology community. According to the company's recent release, the once-daily oral therapy met all primary and secondary endpoints across both the FRONTIER 1 and FRONTIER 2 studies in moderate-to-severe plaque psoriasis, achieving 65% PASI 90 response and 74% IGA 0/1 at Week 24 with its higher dose regimen. These efficacy outcomes and a favorable safety profile suggest that icotrokinra may become the first oral IL-23 pathway inhibitor to reshape the current psoriasis treatment algorithm. Data from Spherix Global Insights' RealTime Dynamix™: Plaque Psoriasis (US) Q1 2025 report confirms heightened interest in icotrokinra among dermatologists (n=103), with many already envisioning its role as a first-line systemic treatment. While unaided awareness of the Phase 3 results was modest, prompted exposure to the data led to a significant uptick in prescriber enthusiasm. In fact, dermatologists rated icotrokinra as the top pipeline agent by a considerable margin, and they would like to see it approved, with interest and likelihood to prescribe scores surpassing all other late-stage psoriasis assets. Notably, over half of dermatologists reported that icotrokinra would be used as a first-line advanced systemic treatment. At the same time, most agree that its availability would expand the pool of psoriasis patients on advanced treatments—a strong indicator that icotrokinra may help bridge the gap between topical and biologic therapies. Importantly, a sizable portion of patients currently treated with oral small molecules (i.e., Otezla or Sotyktu) who are not considered well-managed may be switched to icotrokinra upon availability, underscoring its potential to disrupt the existing oral systemic market. Dermatologists cited its oral convenience, high response rates, and mechanistic familiarity with successful IL-23 biologics like Skyrizi and Tremfya as primary drivers of interest. Data from Spherix's Special Topix™: The Oral Opportunity in Plaque Psoriasis, 2024 study indicate that the availability of efficacious and safe oral agents is the top unmet need for treating psoriasis. Moreover, most dermatologists believe that oral treatment can be just as efficacious as injectable treatment. Despite the positive momentum, some prescribers remain cautiously optimistic, pointing to the need for real-world data and long-term safety monitoring before making widespread practice changes. However, with robust Phase 3 results and clear differentiation from existing oral therapies, icotrokinra is poised to be a game-changer in moderate-to-severe plaque psoriasis. As J&J advances icotrokinra toward regulatory submission, ongoing dermatologist perception tracking will be critical in determining its commercial potential and ultimate impact on the psoriasis landscape. Spherix continues to monitor the PsO market with these insights and more available via its quarterly RealTime Dynamix™ service, and will continuously evaluate the oral opportunities in psoriasis via the Special Topix™ service. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Andy Stankus, Dermatology Franchise Head Spherix Global Insights 4848794284 in to access your portfolio
Associated Press
04-04-2025
- Business
- Associated Press
TREMFYA® (guselkumab) is the first and only IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active psoriatic arthritis
TREMFYA® demonstrated clinically meaningful and statistically significant efficacy in patients with active psoriatic arthritis at risk for structural damage in Phase 3b study Topline results demonstrate efficacy across multiple domains at Week 24, reinforcing TREMFYA® as a first-line treatment option for patients with active psoriatic arthritis SPRING HOUSE, Pa., April 4, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the TREMFYA® (guselkumab) Phase 3b APEX study achieved both its primary endpoint (ACR20a) of reducing signs and symptoms and its major secondary endpoint of reducing progression of structural damage as measured by radiographic progression at 24 weeks, in adults living with active psoriatic arthritis (PsA), compared to placebo.1 TREMFYA® is the first and only fully-human, dual-acting monoclonal antibody approved to treat PsA that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including active psoriatic arthritis.2,3,4,5,6 In the Phase 3b APEX study, TREMFYA®-treated patients also exhibited significantly less progression of structural damage versus patients receiving placebo at Week 24 as assessed by the PsA modified van der Heijde-Sharp (vdH-S) score, which includes joint space narrowing and erosion subscores. Data were consistent with the well-established safety profile of TREMFYA® with no new safety signals identified.1 'Psoriatic arthritis can be a progressive and debilitating disease, and without early identification and treatment, patients may experience irreversible joint damage that significantly impacts their daily activities,' said Terence Rooney, Vice President, Rheumatology Disease Area Leader, Johnson & Johnson Innovative Medicine. 'These new topline data highlight the importance of addressing both inflammation and structural damage at the source as early as possible. As the only IL-23 treatment to show significant inhibition of structural damage, TREMFYA equips healthcare providers with critical data so their patients do not have to compromise their future joint health.' APEX is a Phase 3b study with long-term extension data through three years that will further assesses the sustained efficacy of TREMFYA® on inhibition of structural damage in patients with active PsA. Results from the APEX study are being prepared for presentation at upcoming medical congresses. Editor's notes: a. ACR20 response is defined as both at least 20 percent improvement from baseline in the number of tender and number of swollen joints, and a 20 percent improvement from baseline in three of the following five criteria: patient GA, physician GA, functional ability measure (HAQ-DI), patient-reported pain using a visual analog scale, and erythrocyte sedimentation rate or C-reactive protein.7 ABOUT APEX STUDY ( ) NCT04882098 APEX is a multicenter, randomized, double-blind, placebo-controlled study in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies (e.g., csDMARDs, apremilast, and/or NSAIDs). The treatment duration includes a 24-week, double-blind, placebo-controlled period, followed by a 24-week active treatment period, followed by a 12-week safety follow-up period. For patients who agree to enter the long-term extension, an additional 2 years of active treatment period is scheduled prior to the final safety follow-up.8 ABOUT PSORIATIC ARTHRITIS Psoriatic arthritis (PsA) is a chronic, immune-mediated, inflammatory disease characterized by peripheral joint inflammation, enthesitis (pain where the bone, tendon and ligament meet), dactylitis (a type of inflammation in the fingers and toes that can result in a swollen, sausage-like appearance), axial disease and the skin lesions associated with plaque psoriasis (PsO).9,10,11 The disease causes pain, stiffness and swelling in and around the joints; it commonly appears between the ages of 30 and 50, but can develop at any age.12 Nearly half of patients with PsA experience moderate fatigue and about one-third suffer from severe fatigue as measured by the modified fatigue severity scale.13 In patients with PsA, comorbidities such as obesity, cardiovascular disease, anxiety and depression are often present.14 Studies show up to 30% of people with plaque PsO also develop PsA.11 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cells that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis. adults with moderately to severely active Crohn's disease.10 TREMFYA® is approved in Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: o fever, sweats, or chills o muscle aches o weight loss o cough o warm, red, or painful skin or sores on your body different from your psoriasis o diarrhea or stomach pain o shortness of breath o blood in your phlegm (mucus) o burning when you urinate or urinating more often than normal Liver problems. With the treatment of Crohn's disease or ulcerative colitis, your healthcare provider will do blood tests to check your liver before and during treatment with TREMFYA®. Your healthcare provider may stop treatment with TREMFYA® if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: o unexplained rash o vomiting o tiredness (fatigue) o yellowing of the skin or the whites of your eyes o nausea o stomach pain (abdominal) o loss of appetite o dark urine Do not use TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section 'What is the most important information I should know about TREMFYA®?' have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See 'What is the most important information I should know about TREMFYA®?' The most common side effects of TREMFYA® include: respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, stomach pain, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available as 100 mg/mL and 200 mg/2mL for subcutaneous injection and as a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at or at Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. REFERENCES 1 Data on file 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217. 4 TREMFYA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 Felson, D. T., & LaValley, M. P. The ACR20 and defining a threshold for response in rheumatic diseases: too much of a good thing. Arthritis Research & Therapy, 2014:16(1), 101. 8 A Study of Guselkumab in Participants With Active Psoriatic Arthritis (APEX). Identifier: NCT04882098. Available at: Accessed March 2025. 9 Donvito T., CreakyJoints: What Is Dactylitis? The 'Sausage Finger' Swelling You Should Know About. Available at: Accessed March 2025. 10 Belasco J., Wei N. Psoriatic Arthritis: What is Happening at the Joint? Rheumatol Ther. 2019 Sep;6(3):305-315. Available at: Accessed March 2025. 11 Gower, T. Enthesitis and PsA. Arthritis Foundation. Available at: . Accessed March 2025. 12 National Psoriasis Foundation. About Psoriatic Arthritis. Available at: Accessed March 2025. 13 Husted J.A., et al. Occurrence and correlates of fatigue in psoriatic arthritis. Ann Rheum Dis, 2008:68(10), 1553–1558. Available at: Accessed March 2025. 14 Haddad A., Zisman D. Comorbidities in Patients with Psoriatic Arthritis. Rambam Maimonides Med J 2017 Jan 30;8(1):e0004. Available at: Accessed March 2025.
