Janssen Announces TREMFYA® (guselkumab) Demonstrates Significant Skin Clearance in First-of-its-Kind Prospective, Large-Scale Study Dedicated to People of Color Living with Moderate to Severe Plaque Psoriasis

• VISIBLE Cohort A Week 16 topline results achieve co-primary endpoints, demonstrating the well-established efficacy and safety profile of TREMFYA^® across all skin tones
• In additional datasets, TREMFYA^® demonstrated rapid and significant scalp psoriasis clearance and improved key health-related quality of life outcomes
• VISIBLE aims to generate an expansive longitudinal collection of PsO clinical images across skin tones and novel post-inflammatory pigmentation data to assist providers in helping patients better understand the diagnosis and treatment journey

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

• At Week 16, 74% of patients receiving TREMFYA achieved an Investigator's Global Assessment (IGA) score of cleared (0) or minimal disease (1) and 57.1% achieved at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) response (near complete skin clearance), successfully meeting the study's co-primary endpoints versus placebo (0% and 3.8%, respectively).
• After only three doses, significantly greater improvements in disease signs and symptoms (e.g., change from baseline in PASI scores) were observed in patients receiving TREMFYA (84.5%) versus placebo (8.3%). Significantly greater improvements in body surface area (BSA) involvement were observed in patients receiving TREMFYA (77.9%) versus placebo (0.9%).
• Approximately one-third of patients receiving TREMFYA achieved complete skin clearance PASI 100 (29.9%), IGA 0 (32.5%) versus none for placebo (0%) at week 16.

Guselkumab Rapid and Significant Scalp Psoriasis Clearance Data at Week 16 Poster:²

• As early as Week 4, after only one dose of TREMFYA, the mean percentage improvement from baseline Psoriasis Scalp Severity Index (PSSI) was 53.8% in patients treated with TREMFYA versus 12.3% for placebo.
• After one dose of TREMFYA, 26.3% of participants achieved complete scalp clearance (ss-IGA 0) versus none for placebo (0%) at Week 4.
• At Week 16, 71.9% of patients receiving TREMFYA achieved complete scalp clearance versus 10% for placebo.

Guselkumab Health-Related Quality of Life (HRQoL) and Post-Inflammatory Pigmentation Data Poster:³

• At baseline, VISIBLE participants reported disease signs and symptoms have significant impact on HRQoL. They also reported moderate effect of skin discoloration on HRQOL. Post-inflammatory pigmentation is part of the natural history of psoriasis and is known to be a key factor impacting quality of life.
• VISIBLE was prospectively designed to also collect clinical photographs, colorimetry measures, clinician reported outcomes and patient reported outcomes.
• At Week 16, improvements in the Psoriasis Symptoms and Signs Diary (PSSD), Dermatology Life Quality Index (DLQI) and Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) were significantly greater in patients receiving TREMFYA versus placebo across all skin tones.

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)
Plaque PsO is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.⁸ It is estimated that eight million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.⁹ 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.¹⁰ 

About VISIBLE (NCT05272150)¹¹
VISIBLE (n=211) is a phase 3b, multicenter, randomized, double-blind, placebo-controlled (Weeks 0-16) trial in adult patients (≥18 years of age) with moderate to severe body and/or scalp psoriasis. Patients were randomized to TREMFYA^® 100 mg subcutaneous injection at Weeks 0, 4, and 12, then q8w; placebo at Weeks 0, 4, and 12, followed by crossover to TREMFYA^® at Week 16, Week 20, and q8w. The study was designed to evaluate the efficacy and safety of TREMFYA^® in skin of color patients (self-identify as non-white) across the entire spectrum of the Fitzpatrick scale (I-VI). The study consisted of 2 cohorts, Cohort A: moderate to severe plaque psoriasis (IGA ≥3, PASI ≥12, and body surface area involvement of ≥10%) and Cohort B: moderate to severe scalp psoriasis (SSA ≥30%, PSSI ≥12, ss-IGA ≥3, and ≥1 plaque outside the scalp) for at least 6 months before study administration, or central photo review expert confirmed psoriasis diagnosis, or biopsy confirmed psoriasis. The VISIBLE study is still ongoing with an active treatment period from Weeks 16-48 and long-term extension through Week 112 where patients continued receiving TREMFYA^® q8w.  

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)
Developed by Janssen, TREMFYA^® is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque PsO and active psoriatic arthritis (PsA).^5,12 TREMFYA^® is approved in the U.S., Canada, Japan, and a number of other countries worldwide for the treatment of adults with moderate to severe plaque PsO 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.^5,13,14 It is also approved in the EU for the treatment of moderate to severe plaque PsO in adults who are candidates for systemic therapy and for the treatment of active PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.¹²

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^®?
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:

• fainting, dizziness, feeling lightheaded (low blood pressure)
• swelling of your face, eyelids, lips, mouth, tongue or throat
• trouble breathing or throat tightness
• chest tightness
• skin rash, hives
• itching

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:

• fever, sweats, or chills
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your phlegm (mucus)
• burning when you urinate or urinating more often than normal

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:

• 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.
• 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: 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
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.

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
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of TREMFYA^® (guselkumab). 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., any of the other Janssen Pharmaceutical Companies 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 Annual Report on Form 10-K for the fiscal year ended January 1, 2023, 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 www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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.

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