Recent Developments
PASI-HD Modification Aims at Milder Disease
A new modification to the Psoriasis Area and Severity Index (PASI) published in Dermatology and Therapy aims to address limitations of the scale when used to assess mild to moderate disease. PASI-high discrimination (PASI-HD), developed by Arcutis Biotherapeutics, Inc., in conjunction with leading psoriasis experts, is for use in clinical trials among patients with less than 10 percent BSA involvement.
“As innovation in the space has grown, and we’ve seen a lot of new topical drugs come into the space, we needed to develop a new tool to be able to more precisely estimate and evaluate clinical results,” says Robert Higham, MPAS, PA-C, Executive Director of Clinical Development for Arcutis. He notes that researchers have also used the PGA x BSA to assess response to psoriasis therapy. However, a potential advantage of the new PASI-HD is that it preserves the four anatomical areas—head, torso, upper extemities, and lower extremities—whereas PGA x BSA does not.
“We’re going to continue our research with PASI-HD,” Mr. Higham says. “It’s been used in a number of recent clinical trials with topical treatments in plaque psoriasis. We’re looking forward to a larger manuscript and publication to provide some additional data around that. Traditionally with biologics, we’ve really been focused on the moderate to severe patients, but that quality-of-life impact that occurs with the mild to moderate patient is really important. We want to make sure that we’re able to capture improvement or flares with a precise tool.”
Camp Wonder Goes Live
Camp Wonder, a sleep-over camp for children with skin diseases, returned to in-person programming this year after going virtual last summer due to COVID-19 concerns. June Risser, Vice President and General Manager for Galderma US Consumer Care, returned to the camp as a volunteer this year.
“Galderma has been a supporter of the Children’s Skin Disease Foundation that runs the camp here in California for many years. It’s a wonderful experience for children to experience joy,” she says.
“We are a leading dermatology company who has a really ambitious vision, which is to advance dermatology for every skin story. And that means that we’re serving ultimately consumers and patients along all of their skin health needs,” Ms. Risser shares. “Our ambition really ties very closely to the mission of the Children’s Skin Disease Foundation and Camp Wonder, which is ultimately to help the patient.”
In addition to financial support of the camp, Galderma donates a year supply of appropriate skincare products for each camp attendee. Support for the camp also comes from employees themselves, Ms. Risser says, noting that two employees channeled their “grassroots passion for the organization and the children” to organize the Wonder Run 5k to raise additional funds for the camp.
“For many of these campers, you can imagine their health care costs are already quite high. Another camp cost would be very difficult and prohibitive. The Wonder Run funds many of the campers who are able to come to camp.”
Close Up with John Barbieri, MD, MBA
“I feel like I’m not taken as seriously [or] professionally in my career because I have acne.”
“Sometimes I would go all day. I just wouldn’t even look in the mirror.”
“Acne prevents me from leaving my house. It prevents me from getting my mail without makeup on.”
When asked how acne affects their day-to-day life, these are some of things that women emoted in a lived experience study published in JAMA Dermatology.
Study author John Barbieri, MD, MBA, a dermatologist at Brigham and Women’s Hospital in Boston, spoke with Practical Dermatology® magazine about the study results and the devasting toll that acne can take on the quality of life of adult women.
Why is this Topic Important to Study?
John Barbieri, MD, MBA: Nearly 50 percent of women experience acne in their 20s, and 35 percent experience acne in their 30s. While several qualitative studies have examined acne in adolescence, the lived experience of adult female acne has not been explored in detail. As a result, we conducted a series of semi-structured interviews among 50 adult women with acne to examine the lived experience of adult acne and its treatment.
Describe the Research and Your Findings
Dr. Barbieri: Adult women with acne described acne-related concerns about their appearance that impacted their social, professional, and personal lives. Themes of depression, anxiety, and social isolation were common. Some described feeling that their acne made them appear younger or less professional, trustworthy, or qualified at work. Many described altering their behavior in their social or professional lives due to their acne.
Successful treatment was considered to be having completely clear skin over time or a manageable number of blemishes. With respect to treatments, many participants expressed interest in non-antibiotic treatments for their acne. In addition, concerns about side effects from isotretinoin were common, though those who had used isotretinoin found it to be highly effective. Some respondents expressed frustration with finding a dermatologist with whom they felt comfortable and with identifying effective treatments for their acne.
What is the Next Step?
Dr. Barbieri: It is important for payers to cover treatments for adult women with acne, given the substantial impact of acne in this population. Clinicians should make sure to discuss these themes of depression, social isolation, and impacts on patients’ personal and professional life. Finally, future clinical trials to understand optimal treatment approaches for women with acne are needed to improve outcomes in this population. We are hoping to conduct one such trial comparing a non-antibiotic treatment that addresses the underlying hormonal pathogenesis of acne (spironolactone) versus oral antibiotics for women with acne.
More Headlines from DermWire
Experts: Greater Attention to Persistent Redness of Rosacea Needed
Dermatologists should place greater emphasis on persistent facial erythema of rosacea, a panel of experts concludes. Their recommendations, based on a National Rosacea Society (NRS) roundtable conversation, appear in the Journal of Drugs in Dermatology.
Phase 3 AD Trial Data for Lilly’s Lebrikizumab
Eli Lilly and Company’s lebrikizumab led to significant improvements with at least 75 percent skin clearance in more than half of people with moderate to severe atopic dermatitis (AD), according to top-line results from ADvocate 1 and ADvocate 2.
New Gel Shows Promise Against BCC
Medivir AB’s topical histone deacetylase (HDAC) inhibitor remetinostat performed well in a Phase 2 study in basal cell carcinoma (BCC), according to research published online in Clinical Cancer Research. The new gel could reduce the need for surgical removal of BCC lesions, which can be a costly and burdensome treatment, especially if a patient develops multiple tumors on the skin.
FDA Accepts NDA for Tapinarof Cream for Adults with Plaque Psoriasis
Tapinarof is an investigational, novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Q2 2022.
Skyrizi Available as Single 150mg Injection for Adults with Plaque Psoriasis
Previously administered as two 75mg injections per dose, Abbvie’s Skyrizi (risankizumab-rzaa) 150mg is now administered with one injection per dose— via either a prefilled pen or syringe—every 12 weeks following two starter doses.
Long-term Safety, Efficacy Shown for UCB’s Bimekizumab in PsO
New interim data from an open-label extension trial to assess the long-term safety, tolerability, and efficacy of bimekizumab show that the majority of patients who achieved complete or near complete skin clearance after 16 weeks of bimekizumab treatment maintained these responses through to two years with continuous maintenance dosing, every four weeks (Q4W) or every eight weeks (Q8W).
Rinvoq Performs Well in Phase 3b Study of Adults with Atopic Dermatitis
AbbVie’s JAK Inhibitor Rinvoq (upadacitinib) performed better than dupilumab for primary and all ranked secondary endpoints in a Phase 3b head-to-head study in adults with atopic dermatitis (AD). Findings from the new head-to-head study were published last month in JAMA Dermatology.
Take 5 with Richard Marshall, AstraZeneca
With FDA approval in August of Saphnelo (anifrolumab-fnia) as a treatment for adults with systemic lupus erythematosus (SLE) who are receiving standard therapy, AstraZeneca has found a toehold in the field of dermatology. Saphnelo inhibits the IFNAR receptor of type I interferons. In addition to eyeing other dermatologic disease states, the company is focusing on underserved and rare diseases, having recently acquired Alexion Pharmaceuticals.
Richard Marshall, Senior Vice President and Global Head of Respiratory & Immunology Late Stage Development, BioPharmaceuticals R&D spoke to Practical Dermatology® about the company and its vision in dermatology.
Saphnelo is First-in-Class
“There’s only been one new treatment in the last 60 years for lupus, and that was 10 years ago. So, to say there’s a high unmet need is a bit of an understatement.
“More than 80 percent of patients with SLE will have a signature in their affected tissues of type I interferon upregulation. We think this is a core driver of the disease. Anifrolumab is a biologic with a first-in-class mechanism of action that binds to subunit 1 of the type I interferon receptor. We think it will complement the limited number of existing treatments available.
“We showed very consistently across three trials—one Phase 2 and two Phase 3—that no matter how you measure it, you see clinically meaningful improvements. And if you look at more specific outcomes, for example, skin disease, we saw a significant impact on skin disease. When we look at a severity index of just skin disease, we see clinically meaningful, significant impacts.”
AZ Will Bring Innovation Forward
“We hope to acquire data beyond just the overall lupus indication for anifrolumab to hopefully provide benefit to patients who have more severe skin disease or more severe renal disease. Patients have different balances in terms of which tissues are affected.
“Given we’ve got this first-in-class mechanism, we will explore where else type I interferons are important. Where else are they driving disease? Other autoimmune diseases where you find type I interferon signature sub-channels include myositis, dermatomyositis, and scleroderma. We’re looking across a range of other diseases.”
Skin Disease is a Growing Focus
“Fasenra (benralizumab) targets interleukin-5. It turns out, one of IL-5’s main actions is to moderate the activity of eosinophils. There are a number of conditions in which eosinophils appear to be key drivers, and that includes skin diseases. We have a very aggressive lifecycle management program for Fasenra, and that includes atopic dermatitis, chronic and spontaneous urticaria, and also bullous pemphigoid. We have already started dosing in three studies.
“We also have tezepelumab, which inhibits the TSLP antibody, an epithelial cytokine that drives inflammation. There’s evidence that that mechanism could be important in some skin diseases. We have already conducted a trial in atopic dermatitis and we’re moving forward with chronic and spontaneous urticaria. Another antibody targeting interleukin-33 is in a Phase 2 study in atopic dermatitis.”
Therapeutic Development May Unlock Understanding of Diseases
“We now talk about patients who have high eosinophil asthma and low eosinophil asthma. The same may be true of chronic obstructive pulmonary disease. And I think the same is happening with skin disease. Thinking about autoimmune skin disease, there’s been great success in psoriasis, maybe more mixed success in atopic dermatitis, as two of the most common inflammatory diseases. But I think that having now new drugs available may lead to a different way to characterize patients. I think that will help us unlock a level of disease understanding that we didn’t have before, and that will actually help us innovate. When you see people responding to one drug or another in the clinic, you can then ask, ‘Why are or aren’t they responding?’ That helps you understand which mechanisms may be important for future therapies.”
COVID Spurred Innovation
“We’ve really tried to do everything we can to help fight the pandemic with the vaccine (Vaxzevria, approved outside the US). We also have a monoclonal antibody in development. Importantly, like all pharma companies, patients, and physicians, we’ve also been managing the impact of COVID, including its impact on the care of patients.
“Lupus is a good example of that, where we worked carefully to continue patients in our trials, working closely with regulators and our people that manage the safety of those studies. It has driven us, in a positive sense, to maintain that standard of care and keep patients on the optimal therapy with the optimal clinical care and allow them to participate in clinical trials. We have and will continue to innovate around remote access and the use of digital tools and technology.”
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