NPF COVID-19 Task Force Issues Updated Guidance Regarding COVID-19 Vaccines

The National Psoriasis Foundation (NPF) COVID-19 Task Force developed new guidance addressing use of a vaccine for the prevention of COVID-19 in psoriatic disease patients.

“The new mRNA vaccines are an astonishingly 95% effective in preventing COVID-19 and are extremely safe. We recommend that patients with psoriatic disease get the vaccine as soon as it is available to them. Patients may continue their oral or biologic psoriasis or psoriatic arthritis treatment without interruption when receiving these immunizations,” says Joel Gelfand, MD, MSCE, Professor of Dermatology and Epidemiology at the University of Pennsylvania Perelman School of Medicine and Co-Chair of the NPF COVID-19 Task Force.

The Task Force also updated treatment recommendations for patients who become infected with SARS-CoV-2 based upon current data.

“Advances in therapies over the last several months that include the use of steroids, monoclonal antibodies, and anti-viral agents have lessened mortality and the length of hospital stay in many patients hospitalized for COVID-19,” says Christopher Ritchlin, MD, MPH, Professor of Medicine at the University of Rochester Medical Center and Co-Chair of the NPF COVID-19 Task Force.

The Task Force issued initial guidance statements in August as result of a modified Delphi process, which asked members to provide consensus on important questions posed by patients and health care providers. Methodology, full results, and discussion of these initial guidance statements were published in the Journal of the American Academy of Dermatology in September 2020. A subsequent publication of new statements and updates determined by consensus is in preparation for submission.

“The approval of the first COVID-19 vaccine has provided a light at the end of a tunnel and hope worldwide. Vaccination is a critical step in the fight against this life-changing pandemic. We are so fortunate to have an amazing group of providers and researchers to offer guidance to our community as we navigate this unprecedented time,” adds Stacie Bell, PhD, Chief Scientific and Medical Officer of the National Psoriasis Foundation.

Positive Topline Data from Phase 2b Study of Roflumilast for Scalp and Body Psoriasis

Arcutis Biotherapeutics, Inc., shared positive top line data from a Phase 2b clinical trial evaluating ARQ-154 (topical roflumilast foam) as a potential treatment for scalp psoriasis.

Roflumilast foam 0.3% administered once daily for eight weeks demonstrated statistically significant improvements compared to a matching vehicle foam on key efficacy endpoints in 304 adult and adolescent patients with plaque psoriasis that included plaques on the scalp. On the study’s primary endpoint of Scalp Investigator Global Assessment (S-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 59.1 percent compared to a vehicle rate of 11.4 percent (p<0.0001). S-IGA success is defined as the achievement of an S-IGA score of ‘clear’ or ‘almost clear’ on a 5-grade scale plus at least a two-point change from baseline. Onset was rapid, with significantly higher rates of S-IGA success noted as early as two weeks.

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Multiple secondary endpoints were also met. On the key secondary endpoint of Body Investigator Global Assessment (B-IGA) success assessed at week 8, roflumilast foam 0.3% achieved a rate of 40.3 percent compared to a vehicle rate of 6.8 percent (p<0.0001), with separation from vehicle on B-IGA success as early as two weeks. Symptomatic improvement was also demonstrated, with 71.0% of subjects treated with roflumilast foam 0.3% who had a baseline Scalp Itch Numeric Rating Scale (SI-NRS) score of 4 or greater achieving an itch reduction of at least 4 points at week 8 compared to 18.5 percent of vehicle treated subjects (p<0.0001). Consistent with other clinical trials of topical roflumilast, roflumilast foam was well-tolerated, as evidenced by subject-reported local tolerability and rates of application site adverse events, treatment-related adverse events, and discontinuations due to adverse events low and similar to vehicle. Five out of 200 subjects (2.5 percent) in the roflumilast foam treated group discontinued the study due to an adverse event, compared to two out of 104 subjects (1.9 percent) treated with the vehicle.

“Scalp psoriasis inflicts a high burden for patients, and current treatment options often carry significant treatment limitations that result in poor outcomes and can have a negative impact on patient quality of life,” says Leon Kircik, MD, Clinical Professor of Dermatology, Icahn School of Medicine at Mount Sinai, Indiana University Medical Center, and Medical Director, Physicians Skin Care, DermResearch, and Skin Sciences. “Roflumilast once-daily foam demonstrated rapid and significant improvements in psoriasis signs and symptoms, including reducing itch in a meaningful way. These positive results are encouraging for patients and clinicians who are desperate for new treatments that can simplify disease management, can be used in all areas of the body, and can ultimately improve the patient experience.”

Metabolic Syndrome Linked to Higher Cardiovascular Risk in Psoriasis Patients

Metabolic syndrome in people with psoriasis may contribute to an increased risk of heart disease, according to a study in the Journal of the American Academy of Dermatology.

Partly because it worsens vascular and systemic inflammation, psoriasis not only increases but speeds up atherosclerosis. Metabolic syndrome affects about 25 percent of adults and is on the rise, and its prevalence is even greater among patients with psoriasis. Nehal N. Mehta, MD, MSCE, preventive cardiologist and head of the NHLBI’s Lab of Inflammation and Cardiometabolic Diseases, spoke with Practical Dermatology® magazine about the study. Read more in the News section.

Dermatologists Not WELL REPRESENTED in Psoriasis Discourse on Twitter

Although a new analysis shows a fair amount of psoriasis-related content on Twitter, the majority of psoriasis posts are focused on advocacy, and hardly any are mediated by dermatologists.

“To our surprise, the most prevalent subject among psoriasis patients on Twitter was not related to treatment (5.2 percent), but rather advocacy (75.2 percent). Specifically, patient-to-patient advocacy dominated the conversation and consisted of patients sharing disease experiences, perspectives, and advice with each other,” says Wendy Li, MD, lead author of the study published online in Journal of the American Academy of Dermatology in November.

Dr. Li notes that in previous psoriasis-related social media studies, topics pertaining to treatment options were the most prevalent or advocacy was not mentioned at all. “In the setting of well-documented problems with social stigma and social isolation, the prevalence of advocacy-related tweets implies that patients are turning to Twitter as an important source of psychosocial support,” she says.

Physicians are represented in the psoriasis discourse, and most of their tweets are related to patient education, Dr. Li says. However, “their visibility was eclipsed by commercial accounts, which published nine times more tweets promoting treatments. Furthermore, less than a third of healthcare provider accounts were identified as dermatologists,” she says. “Our findings signify a call to action for dermatologists to expand their social media presence help address gaps in patient education. For example, dermatologists can engage patients by posting interactive or educational content. They can also either promote or facilitate online patient support groups or organizations so that patients are aware of the resources that are available.”

To read more about the study and Dr. Li’s take on the findings, visit us online at PracDerm.com/PsoriasisUpdate.