Shots:

• Daphne talked about the P-III study evaluating the safety and efficacy of Tremfya in people of color living with moderate to severe plaque psoriasis
• Daphne also spoke about how this clinical study will contribute to fill the gaps in care of people who are devoid of treatment due to racial and ethnic variations
• The interview gives an understanding how Janssen is advancing its lead candidate, Tremfya, to address the unmet needs of patients

Smriti: Throw some light on the study design “VISIBLE” evaluating TREMFYA.

Daphne: Janssen’s VISIBLE study is a first-of-its-kind, large-scale prospective clinical study in dermatology solely dedicated to people of color (Black, Hispanic, Asian, Indigenous and others) living with moderate to severe plaque psoriasis.

TREMFYA® (guselkumab) has a well-established safety and efficacy profile across a broad patient population of adults with moderate to severe plaque psoriasis and the VISIBLE study is intended to generate additional valuable data about psoriatic disease and the patient journey experienced by people of color.

The VISIBLE study is a Phase 3b, multicenter, randomized, double blind, placebo-controlled study further evaluating the safety and efficacy of TREMFYA for the treatment of moderate to severe plaque psoriasis and/or moderate to severe scalp psoriasis in people of color. The study will evaluate about 200 participants from the U.S. and Canada, and participants will be treated and followed for approximately two years.

Smriti: Explain the epidemiology of Plaque Psoriasis.

Daphne: Plaque psoriasis is the most common form of psoriasis – about 80 to 90 percent of the 8 million people living with psoriasis in the U.S. have plaque psoriasis. The disease is associated with accelerated skin cell growth which leads to patches of thick, raised skin called plaques. Plaques generally form on the scalp, elbows, knees, or lower back, but they can develop in any body region. Patients may experience itch, pain, stinging, burning, and other bothersome symptoms.

The true prevalence of psoriasis in people of color is unknown and likely underestimated. In the literature, it has been reported that psoriasis affects 1.5% of the Black population in the U.S, 1.9% of the Hispanic population and 2.5% of the Asian population, as compared to 3.6% of Caucasians. The reported lower prevalence in people of color may be partially explained by the higher rates of misdiagnosis and delayed diagnosis that patients with darker skin tones often experience. One contributing factor is the way that psoriasis is manifested in different skin tones. For example, psoriasis is more readily identified in people with lighter skin tones because people with darker skin tones may present with less noticeable skin reddening (e.g., a sign of active, inflamed skin). In darker skin tones, skin reddening may appear more purple, red-purple or red-brown, which may be less readily recognized (as psoriasis) for healthcare providers who are less familiar with the presentation of psoriasis across all skin tones.

Smriti: How do you think this study will contribute to the field of psoriasis, including potential impact to people of color living with psoriasis?

Daphne: There is an urgent need to prioritize diversity and inclusion in clinical studies across therapeutic areas, including dermatology. More than 80% of patients across phase 3 psoriasis clinical trials have been white participants. [1]^,[2] That’s why we set out to work with leaders in the field and designed the VISIBLE study to help create a more diverse and equitable clinical research process that aims to reduce this disparity, including new approaches to enrollment and retention, diagnosis confirmation, broader community engagement, and investigator training on DEI best practices.

The goal of this research is to provide both patients and physicians with new information that can better inform treatment decisions that may help break down barriers to access treatment, including biologic therapies, which in turn can help improve health outcomes for people of color living with moderate to severe plaque psoriasis. We also hope the VISIBLE study serves as a positive example to other organizations and researchers in the field of how we can work together to approach clinical trial design in a way that provides all patients the opportunity to participate, be represented and benefit from advancements in treatment, especially in dermatology where people of color are underrepresented and face significant barriers to care.

Smriti: How does the VISIBLE study contribute to broadening patient and healthcare provider education in psoriasis and in clinical research, in communities of color?

Daphne: Patient and provider education is a key priority for the VISIBLE study team. Because psoriasis presents differently in people of color, we’re taking a grassroots approach – on the ground and in diverse communities – to raise awareness of the condition, offer training support for study investigators, and encourage study participation. The study will also generate a collection of clinical photos across different skin tones that will serve as an educational resource for patients and healthcare providers on how psoriatic disease presents in people of color. There is a critical gap in visuals of disease presentation on darker skin tones, so our hope is that this new medical imagery will help providers better diagnosis psoriasis in people of color.

Smriti: TREMFYA is an established product in the immunology disease area. What additional life cycle development plans does Janssen have for TREMFYA, and what is Janssen doing beyond psoriatic disease development?

Daphne: Janssen’s vision in clinical development is a pathway-centric scientific approach that cuts across traditional disease boundaries and provides the opportunity to develop one drug to treat many diseases, reaching broader patient populations. Consistent with this vision, Janssen continues to invest in generating new evidence for TREMFYA’s existing approved indications in psoriasis and psoriatic arthritis to inform clinical practice, while also exploring its potential to advance care for patients with other immune-mediated diseases beyond psoriatic disease.

For example, in psoriasis we recently presented new data from the phase 3 VOYAGE 1 and VOYAGE 2 clinical trials which showed a majority of adults with moderate to severe plaque psoriasis treated with TREMFYA experienced durable skin clearance through five years regardless of metabolic syndrome status, baseline disease severity or treatment history. Additionally, earlier this year, Janssen published the results of a network meta-analysis that compared all published Phase 3 data for approved treatments for adults with active psoriatic arthritis, which found TREMFYA ranked highest for overall level of skin clearance and showed positive joint efficacy among 23 active psoriatic arthritis therapies.

Beyond psoriatic disease, Phase 3 clinical trials evaluating TREMFYA for the treatment of moderately to severely active Crohn’s disease and ulcerative colitis are also ongoing and enrolling participants. Results from the Phase 2 portions of these studies have been presented and indicate the potential role of TREMFYA in these disease areas with high unmet needs.

At Janssen, we continue to act on our legacy and commitment in investigating pathway science and developing treatments that address unmet patient needs, which is supported by our Immunology R&D program with over 20 treatments in Phase 2 or 3 clinical development.

Source: Canva

About the Author:

Dr. Daphne Chan, PhD, MHEcon is the Head of Dermatology Medical Affairs at Janssen. She is responsible for leading a team of clinicians and scientists who conduct P-III/IV clinical trials designed to address unmet needs in the post-approval setting. Dr. Chan has 17+ years of clinical development and medical affairs experience in the pharmaceutical industry.She completed her undergraduate training in Human Biology and Toxicology, and her doctoral training in Clinical Pharmacology at the University of Toronto, Canada.

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