TREMFYA® (guselkumab) Demonstrates Significant and Rapid Scalp Psoriasis Clearance in People of Color in New Large Phase 3b Study

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Jan 22, 2024, 08:00 ET

Data illustrates rapid and significant clearance in moderate to severe scalp psoriasis and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks

First-of-its-kind study adds to growing body of evidence demonstrating that TREMFYA^® is effective for adults with moderate to severe plaque psoriasis across all skin tones

The VISIBLE clinical program will produce an expansive longitudinal collection of more than 20,000 clinical images across all skin tones to support patients and providers with disease recognition

HORSHAM, Pa., Jan. 22, 2024 /PRNewswire/ -- Johnson & Johnson today announced that TREMFYA^® (guselkumab) demonstrated rapid and significant clearance in moderate to severe scalp psoriasis (PsO) and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks. Topline data from Cohort B in the Phase 3b VISIBLE study were presented today at the Maui Derm Hawaii 2024 conference.

VISIBLE is the first prospective, large-scale, randomized-controlled trial dedicated to people of color across all skin tones with moderate to severe plaque PsO and scalp PsO to objectively measure clearance and other treatment outcomes with TREMFYA. The VISIBLE clinical program will produce an expansive longitudinal collection of more than 20,000 clinical images across all skin tones to support patients and providers with disease recognition and education. Cohort B of the study enrolled 108 people of color with scalp predominant moderate-to-severe PsO, a clinically proven difficult-to-treat area. TREMFYA demonstrated significant and rapid scalp PsO clearance and improvement in scalp itch as well as patient-reported health-related quality of life (HRQoL) outcomes.^1,2,3

"Scalp psoriasis is highly prevalent and can present unique challenges across diverse populations. In patients of color, cultural factors related to hair care practices and post-inflammatory pigment changes contribute to the burden of scalp psoriasis. These findings from VISIBLE are key to broadening our understanding of scalp psoriasis, and the role TREMFYA can have in treating all patients with this disease," said Andrew Alexis, M.D., M.P.H., Professor of Clinical Dermatology and Vice Chair for Diversity and Inclusion at Weill Cornell Medicine in New York and Lead Study Investigator. "The VISIBLE study will continue to generate insights and data that may help clinicians improve the disease journey and health outcomes for people of color with skin and scalp plaque psoriasis who have historically been undertreated and underrepresented in clinical research and in medical education."

Guselkumab Significant and Rapid Scalp Clearance Data at Week 16 Poster:¹

At Week 16, after three doses, patients receiving TREMFYA achieved significantly greater improvements versus placebo:

At Week 16, nearly 7 in 10 patients receiving TREMFYA achieved the study's co-primary endpoints, Scalp-Specific Investigator Global Assessment (ss-IGA) score of 0/1 (68.4% vs 11.5% placebo) and Psoriasis Scalp Severity Index (PSSI) 90 response (65.8% vs 3.8% placebo). Of note, ~90% of patients who met the study's co-primary endpoints achieved complete scalp clearance (ss-IGA 0 or PSSI 100).
Patients receiving TREMFYA experienced nearly 90 percent improvement from baseline in PSSI (87.6% vs 37.8% placebo) and in Scalp Surface Area (SSA) (86.6% vs 33.4% placebo).
In this previously understudied population, no new safety signals were reported through Week 16.

Guselkumab Patient-Reported Health-Related Quality of Life (HRQoL) Improvements Poster:²

Scalp PsO is often associated with bothersome symptoms such as intense pruritus and scaling. In some cases, it can even result in alopecia which, in most cases, is reversible with appropriate and timely treatment.
At Week 16, nearly 7 in 10 patients receiving TREMFYA (69.4% vs 24% placebo) achieved a clinically meaningful improvement on the Scalp Itch Numeric Rating Scale (NRS).
At Week 16, significantly greater improvements in the Psoriasis Symptoms and Signs Diary (PSSD) and Dermatology Life Quality Index (DLQI) were reported by patients receiving TREMFYA versus placebo across all skin tones.

Guselkumab Patient-Reported Post-Inflammatory Pigmentation Data Poster:³

Post-inflammatory pigment alteration (PIPA) refers to the skin discoloration that may occur after skin inflammation or injury, which is a part of the natural process of inflammatory diseases like psoriasis. PIPA can affect all skin tones and significantly impact quality of life, particularly for those with melanin-enriched skin types.
At baseline, mean score as assessed by the Skin Discoloration Impact Evaluation Questionnaire (SDIEQ) indicated patients were experiencing at least moderate impact of skin discoloration on their HRQoL.
At Week 16, patients treated with TREMFYA reported they have experienced improvements, with only a mild effect from skin discoloration on their HRQOL. TREMFYA is not intended to treat PIPA.

Cohort A of the VISIBLE study, announced in October 2023, focused on patients of color with skin predominant PsO and provided additional data on the safety and effectiveness of TREMFYA across all skin tones. Coupled with the latest Cohort B findings, the collective data reinforces that the unique study design of VISIBLE is a successful model to enroll, retain and support people of color who have historically been undertreated and underrepresented in clinical trials, and an inclusive research process may create lasting impact on furthering medical education and patient education.

"Scalp psoriasis can be particularly burdensome to patients as it often impacts more visible areas of the body, including the hairline, forehead, neck, and around the ears, triggering feelings of self-consciousness that limit many people's lifestyle choices," said Jennifer Davidson, D.O., Vice President of Medical Affairs, Immunology, Johnson & Johnson Innovative Medicine. "The VISIBLE study suggests that people of color continue to experience undertreatment, with many participants not receiving a biologic option prior to this trial enrollment. The insights from the study aim to empower diverse patients with moderate to severe plaque and scalp psoriasis to learn more about their treatment options and initiate informed discussions with their providers."

TREMFYA is the first IL-23 inhibitor approved in the U.S. to treat both adults with moderate to severe plaque PsO who are candidates for systemic therapy or phototherapy and adults with active psoriatic arthritis (PsA).

Editor's Note:

TREMFYA is a biologic therapy approved for adult patients 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.⁴
Dr. Andrew Alexis is a paid consultant for Janssen Global Services, a subsidiary of Johnson & Johnson, and serves as an advisory board member for Johnson & Johnson. 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.⁵ 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.⁶ 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.⁷

About VISIBLE (NCT05272150)⁸
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 psoriasis (PsO) and active psoriatic arthritis (PsA).^4,9TREMFYA 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.^4,10,11 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.⁹

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 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 https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are both 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 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. 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. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

¹ Alexis A, McMichael A, Bhutani AO, et al. VISIBLE Cohort B: Guselkumab Demonstrates Significant Scalp Clearance at Week 16 in Participants With Moderate-to-Severe Scalp Psoriasis Across All Skin Tones. Presented at Maui Derm Hawaii 2024, January 22-26.
² Stein Gold L, Soung J, Heath CR, et al. VISIBLE Cohort B: Guselkumab Improves Key Health-Related Quality of Life Measures at Week 16 in Participants With Moderate-to-Severe Scalp Psoriasis Across All Skin Tones. Presented at Maui Derm Hawaii 2024, January 22-26.
³ Yueng J, Vashi N, Shahriari M, et al. VISIBLE Cohort B: Guselkumab Improves Patient Reported Impact of Skin Discoloration at Week 16 in Participants With Moderate-to-Severe Scalp Psoriasis Across All Skin Tones. Presented at Maui Derm Hawaii 2024, January 22-26.
⁴ 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 January 2024.
⁵ National Psoriasis Foundation. About Psoriasis. https://www.psoriasis.org/about-psoriasis. Accessed January 2024.
⁶ National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed January 2024.
⁷ National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis. Accessed January 2024.
⁸ 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 January 2024.
⁹ 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 January 2024.
¹⁰ Japan Pharmaceuticals and Medical Devices Agency. Tremfya Report on the Deliberation Results. Available at: https://www.pmda.go.jp/files/000234741.pdf. Accessed January 2024.
¹¹ The Canadian Agency for Drugs & Technologies in Health. TREMFYA Prescribing Information. Available at: https://pdf.hres.ca/dpd_pm/00042101.PDF. Accessed January 2024.