Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial, the first prospective, large-scale, randomized-controlled trial dedicated to patients across all skin tones with moderate to severe plaque psoriasis and scalp psoriasis to objectively measure clearance and other treatment outcomes with TREMFYA® (guselkumab).
|
[20-October-2023] |
HORSHAM, Pa., Oct. 20, 2023 /PRNewswire/ -- Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, today announced new Phase 3b topline Week 16 results from Cohort A of the VISIBLE trial, the first prospective, large-scale, randomized-controlled trial dedicated to patients across all skin tones with moderate to severe plaque psoriasis and scalp psoriasis to objectively measure clearance and other treatment outcomes with TREMFYA® (guselkumab). In the study, TREMFYA demonstrated significant skin clearance, rapid scalp psoriasis clearance and improvement in health-related quality of life outcomes. In this previously understudied population, no new safety signals were reported through Week 16.1,2,3 These data will be presented today at the 2023 Fall Clinical Dermatology Conference in Las Vegas, Nevada. "VISIBLE reinforces that to overcome the barriers of underrepresentation, undertreatment, and lack of access to care that many people of color with plaque psoriasis face, additional data about the disease journey are needed to improve treatment outcomes and quality of life for people with skin of color," said Mona Shahriari, M.D., Central Connecticut Dermatology and VISIBLE Steering Committee member. "In addition to insightful data, VISIBLE has provided the medical community with key learnings around study design and representative clinical imagery that have the potential to tangibly address the unmet needs of the diverse psoriasis patient population." Guselkumab Skin Clearance Data at Week 16 Poster:1
Guselkumab Rapid and Significant Scalp Psoriasis Clearance Data at Week 16 Poster:2
Guselkumab Health-Related Quality of Life (HRQoL) and Post-Inflammatory Pigmentation Data Poster:3
VISIBLE will continue to expand understanding of plaque PsO by aiming to generate an expansive, longitudinal library of thousands of clinical images capturing the disease's presentation across all skin tones. Only 4-19% of images in dermatology textbooks showcase conditions in darker skin tones, illustrating the opportunity for VISIBLE to contribute to medical education by helping clinicians recognize clinical presentation across all skin tones and supporting patients to better understand their diagnosis with images of other patients who look like them.4 The study used a holistic, community-driven approach that leads with intentional site and investigator selection from diverse communities, involvement of a racially and ethnically diverse steering committee of dermatologists involved in protocol development and study execution, community engagement and awareness building, as well as educational and cultural training support for clinical investigators. Colorimetry was utilized as an objective method to determine baseline skin tone and track progress of psoriatic lesions to help minimize potential investigator subjectivity and bias. "The VISIBLE study is a direct representation of where scientific innovation meets inclusivity as it will continue to generate new data and imagery to help create a world where people of color living with plaque psoriasis, and their providers, can have more informed discussions about treatment options," said Jennifer Davidson, D.O., Vice President, Medical Affairs, Immunology, Janssen Scientific Affairs, LLC. "Partnering alongside community-driven clinicians and researchers is critical to create new research standards where diversity is both expected and necessary to represent the communities we all serve. Our aim is for VISIBLE to help transform research processes and education for so many more patients." TREMFYA is the first IL-23 inhibitor approved in the U.S. to treat both adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis (PsA). Editor's Note: a. TREMFYA® is a biologic therapy approved for adult patients with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light), and for the treatment of adult patients with active PsA.5 b. VOYAGE 1 (n=837) and VOYAGE 2 (n=992) were phase 3, multicenter, double-blind, placebo-controlled trials in adult patients with moderate to severe plaque PsO. Patients were randomized to TREMFYA® 100 mg subcutaneous injection at Weeks 0, 4, and 12, then every 8 weeks (q8w); placebo at Weeks 0, 4, and 12, followed by crossover to TREMFYA® at Week 16, Week 20, and q8w; or active comparator through Week 47 (VOYAGE 1) or Week 23 (VOYAGE 2). In VOYAGE 1, patients initially randomized to active comparator entered a washout period after their final dose at Week 47 and entered open-label TREMFYA® from Week 52-252. VOYAGE 2 incorporated a randomized withdrawal and re-treatment from Week 28-72, followed by open-label TREMFYA® from Week 76-252. Safety was assessed through Week 264.6,7 c. Biologics are a class of prescription treatments that block specific parts of the immune system responsible for inflammation and causing plaque PsO and its symptoms when overactive in the body. d. Dr. Andrew Alexis is a paid consultant for Janssen. He has not been compensated for any media work. About Plaque Psoriasis (PsO) About VISIBLE (NCT05272150)11 The study will evaluate approximately 211 participants from the U.S. and Canada who will be treated and followed for approximately two years. About TREMFYA® (guselkumab) The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to TREMFYA®. IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA®? 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:
Do not take 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:
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®? The most common side effects of TREMFYA® include: upper respiratory infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, 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 www.fda.gov/medwatch, or call 1-800-FDA-1088. About the Janssen Pharmaceutical Companies of Johnson & Johnson Learn more at www.janssen.com. Follow us at @JNJInnovMed and @JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are a part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Cautions Concerning Forward-Looking Statements References 1 Alexis A, McMichael A, Choi O, et al. VISIBLE: Guselkumab demonstrated skin clearance at week 16 in participants with moderate-to-severe plaque psoriasis across all skin tones. Presented at 2023 Fall Clinical Dermatology Conference, October 19-22. 2 McMichael A, Gold LS, Soung J, et al. VISIBLE: Guselkumab demonstrated rapid and significant scalp psoriasis clearance in participants with moderate-to-severe plaque psoriasis across all skin tones. Presented at 2023 Fall Clinical Dermatology Conference, October 19-22. 3 Soung J, Alonso-Llamazares J, Lee M, et al. VISIBLE: Guselkumab improves key health-related quality of life measures in participants with moderate-to-severe plaque psoriasis across all skin tones. Presented at 2023 Fall Clinical Dermatology Conference, October 19-22. 4 Ebede T, Papier A. Disparities in dermatology educational resources. J Am Acad Dermatol. 2006 Oct;55(4):687-90. Doi: 10.1016/j.jaad.2005.10.068. PMID: 17010750. 5 Food and Drug Administration. TREMFYA® Prescribing Information. Horsham, PA. 2017. Available at: https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/TREMFYA-pi.pdf. Accessed October 2023. 6 Papp KA, et al. Patient–reported symptoms and signs of moderate–to–severe psoriasis treated with guselkumab or adalimumab: Results from the randomized VOYAGE 1 trial. J Eur Acad Dermatol Venereol. 2018;32(9):1515–1522. Published online April 10, 2018. Doi: 10.1111/jdv.14910. 7 Reich K, et al. Efficacy and safety of guselkumab, an anti-interleukin-23 monoclonal antibody, compared with adalimumab for the treatment of patients with moderate to severe psoriasis with randomized withdrawal and retreatment: Results from the phase III, double-blind, placebo- and active comparator–controlled VOYAGE 2 trial. J Am Acad Dermatol. 2017;76(3):418-431. 8 National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed October 13, 2023. 9 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed October 13, 2023. 10 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed October 13, 2023. 11 Clinicaltrials.gov. Study of Guselkumab in Skin of Color Participants With Moderate-to-severe Plaque and/ or Scalp Psoriasis (VISIBLE). Identifier NCT05272150. https://clinicaltrials.gov/study/NCT05272150. Accessed October 13, 2023. 12 European Medicines Agency. TREMFYA Summary of Product Characteristics. Last Updated July 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf. Accessed October 13, 2023. 13 Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the Deliberation Results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed October 13, 2023. 14 The Canadian Agency for Drugs & Technologies in Health. TREMFYA Prescribing Information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed October 13, 2023.
SOURCE Janssen Pharmaceutical Companies of Johnson & Johnson |