• Arcutis convened the Genital Psoriasis Wellness Consortium, a multidisciplinary group of clinicians who are experts in their fields
• Publication includes 14 consensus statements aimed at improving diagnosis, treatment, outcomes, and shared decision-making
• Genital involvement occurs in approximately two-thirds of the nine million individuals with plaque psoriasis

WESTLAKE VILLAGE, Calif., May 15, 2025 (GLOBE NEWSWIRE) --  Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium on the impact of genital psoriasis on patients in the Journal of the European Academy of Dermatology and Venereology (JEADV) Clinical Practice. The consensus statements are aimed at providing expert, multidisciplinary guidance in three key areas: (1) physical diagnosis and patient conversations, (2) impact on quality of life and interpersonal relationships, and (3) treatment decisions.

“Despite affecting an estimated six million Americans, genital psoriasis is often underreported and undertreated​​ due to the uniquely sensitive and private nature of the afflicted areas, and uncertainty for how to begin the conversation. Relative to psoriasis in other areas of the body, genital psoriasis also has a greater impact on psychological well-being and quality of life, interpersonal relationships, intimacy, feelings of stigmatization, and rates of depression,” said Jennifer C. Cather, MD, FAAD, Medical Director and Founder of Mindful Dermatology and Modern Research Associates in Dallas, Texas, Genital Psoriasis Consortium member, and manuscript author. “With the current lack of formal guidelines around genital psoriasis, the goal of convening the Consortium was to bridge the gaps in clinician-patient communication, develop tools and processes that aid in identification and diagnosis, and better-informed shared treatment decisions.”

To formulate the consensus statements, a PubMed literature search was conducted, and a total of 78 unique publications were reviewed. Consortium members used a modified Delphi process, including a nominal group technique. The process included two rounds of virtual subcommittee meetings focused on the three key areas, followed by surveys to obtain anonymous feedback, and concluded with a final meeting to discuss and finalize the language of the consensus recommendations.

“Normalizing conversations and improving shared decision-making are critical first steps to improving outcomes. Implementation of the Consortium’s new guidelines could provide consistent, streamlined care practices that don’t currently exist for this condition,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer of Arcutis. “Arcutis is proud to support the Consortium’s efforts to challenge the status quo to improve care for those with genital psoriasis.”

Below are the 14 consensus statements outlined in the publication:

• Genital psoriasis needs to be a distinct diagnosis with a unique ICD-10-CM code.
• A customized, comprehensive skin examination may help ensure proper diagnosis and complete capture of all affected body sites.
• Biopsy, specifically for the evaluation of genital psoriasis, is generally reserved for cases with inadequate response to treatment or when the diagnosis is in question.
• It is important to normalize comprehensive skin examinations, including genital exams, for patients as early in the process as possible, as well as maximize patient comfort during the examination.
• Using a dialogue guide at the start of an examination can help normalize genital psoriasis and make the patient more comfortable with consenting to and undergoing a comprehensive skin examination.
• When treating pediatric patients, it is important to establish trust and to explicitly request permission for examination from both the patient and the parent/guardian. Inclusion of the guardian in the examination process can help achieve this.
• Genital psoriasis affects relationships including intimate and non-intimate interpersonal relationships, as well as participation in social, educational, and vocational activities across the lifespan.
• Diagnosing genital psoriasis early is critical as the signs, symptoms, and psychological burden of genital psoriasis may worsen over time.
• Collect standardized information at registration, ideally within an electronic medical records (EMR) system.
• We propose the following questions as a starting point to capture the cumulative life impact of genital psoriasis in the clinic to optimize individualized patient care:
  • How much does your genital psoriasis affect your overall quality of life?
  • How much does your genital psoriasis affect each of the following types of relationships: intimate relationships, non-intimate interpersonal relationships?
  • How much does your genital psoriasis impact your daily decisions (i.e., participation in physical activities, choice of clothing, attendance of social events)?
• Existing validated assessment tools, such as the following, should be consistently applied in clinical research in genital psoriasis: Static Physician's Global Assessment of Genitalia (sPGA-G), Dermatologic Intimacy Scale (DIS; preliminarily validated), Psychological General Well-Being (PGWB) Index, and Patient Health Questionnaire (PHQ)-9.
• Treatment options can be evaluated for use in genital psoriasis by their current level of evidence based on U.S. Food and Drug Administration approval, efficacy/safety data from clinical trials, and recommendation by specialty guidelines.
• Comprehensive shared decision-making for genital wellness (including preferences for personalized treatment goals, route of administration, impact on family planning, and acceptance of potential safety profiles) is a foundational pillar in the treatment selection process for genital and perigenital psoriasis.
• The goal for genital psoriasis treatment should be to obtain improvement/resolution as soon as possible while optimizing personalized care for genital wellness and limiting potential adverse events.

About Arcutis

Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to invent differentiated therapies against biologically validated targets, and has produced a robust pipeline with multiple follow-on clinical programs for a range of inflammatory dermatological conditions including atopic dermatitis and alopecia areata. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential real-world use results of ZORYVE foam and the potential for ZORYVE to advance the standard of care in plaque psoriasis, atopic dermatitis and seborrheic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2025, as well as any subsequent filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

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