Learn more about what treatments are on the rise for plaque psoriasis, the latest management advice and what trends are shaping the future of the disease. 

The changing treatment landscape of plaque psoriasis

Etrasimod (APD334, Arena Pharmaceuticals) may disrupt multiple pathways that cause acute and chronic disease phases of atopic dermatitis (AD) by changing sphingosine 1-phosphate receptor 1 (S1p1). Emma Guttman-Yassky, MD, PhD, the Sol and Clara Kest professor of dermatology and vice chair for research at the department of dermatology at the Icahn School of Medicine at Mount Sinai Medical Center, New York City, New York, presented the results from the ADVISE (NCT04162769) study at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021).

Etrasimod is a once-daily, oral S1P1,4,5 modulator with investigation underway in multiple phase 3 trails for moderate to severe ulcerative colitis (UC). It is also being studied for other immune-mediated inflammatory conditions such as alopecia areata, eosinophilic esophagitis, and Crohn’s disease. 

The phase 2, 12-week, placebo-controlled trial was the first to evaluate the S1P receptor modulation as a potential mechanism for treatment of patients with atopic dermatitis (AD). Its objective is to assess the safety and efficacy of etrasimod in patients with moderate to severe AD.

The study enrolled 140 participants across the United States, Canada, and Australia with a 1:1:1 randomization. The inclusion criteria were comprised of male and female participants 18 to 70 years of age, having an Eczema Area and Severity Index (EASI) score of at least 16, a validated Investigator Global Assessment (vIGA) score of 3 or more and a body surface area (BSA) of 10% or more. 

The patients were split into 3 treatment arms: etrasimod 1 mg, etrasimod 2 mg, or placebo. After 12 weeks of treatment, there was a follow up visit at Week 16. At that point, patients were enrolled in an ongoing 52-week open-label extension study that will end with a follow up again at Week 72.

The primary endpoint was the percent change in EASI score from baseline to Week 12. The key secondary endpoint was the proportion of participants with a vIGA score of 0 or 1, defined as clear or almost clear, and decrease from baseline of at least 2 points at Week 12. Client reported outcomes contained the percent change in weekly Peak Pruritus Numerical Rating Scale (NRS) at Week 12, the change in Dermatology Life Quality Index (DLQI) and changes in the Patient-Oriented Eczema Measure (POEM) from baseline to Week 12. 

“In terms of demographics, there were highly balanced groups, but I want to point out that the vast majority of patients were moderate, not severe patients,” Guttman-Yassky said. 

The proportion of participants achieving vIGA at Week 12 was 13% of placebo, 14.9% etrasimod 1 mg, and 29.8% etrasimod 2 mg. Similar results were seen in the weekly pruritus NRS data with 27% placebo, 32.5% etrasimod 1 mg, and 42.1% of the etrasimod 2 mg group achieving a 4-point or greater improvement at Week 12. 

In terms of DLQI scores, the etrasimod 2 mg group performed best with more than 85% achieving a 4-point improvement, followed by 82.9% etrasimod 1 mg and 64.1% placebo at Week 12. POEM scores were different, with 80% of the etrasimod 1 mg group achieving a 4-point improvement, followed by 73% etrasimod 2 mg, and 43.6% placebo.

There were 8 Grade 1 through 3 treatment emergent adverse events (TEAEs) of lymphocyte decrease in the etrasimod groups: one in the 1 mg and 7 in the 2 mg group. Lymphocyte count decrease is an on-target effect of etrasimod and the means by which the investigational drug potentially confers therapeutic benefit, according to Guttman-Yassky.

The safety data exhibited adverse events (AEs) that affected more than 5% in any treatment group. AEs included nausea, constipation, urinary tract infection, back pain, dizziness, headache, and atopic dermatitis. No serious adverse events (SAEs) were observed.

In conclusion, etrasimod 2 mg improved both patient and clinician assessed outcomes at Week 12. The 2 mg treatment also had a greater proportion of participants who achieved an vIGA score of 0 or 1 and a DLQI and POEM improvement of 4 points or more at Week 12 compared to placebo. It was also well tolerated in patients with atopic dermatitis with consistent safety profiles to previous studies and no SAEs.

“These results support the rationale of S1p1 modulation as a potential new mechanism of action and oral treatment for patients with atopic dermatitis and I think this suggests it should be further investigated in a phase 3 clinical trials,” Guttman-Yassky said.

Emma Guttman-Yassky has acted as a consultant for and received grants/honoraria from AbbVie; Anacor; Celgene; Celsus Therapeutics; Dermira; Galderma; Glenmark; Janssen Biotech; LEO Pharmaceuticals; MedImmune; Novartis; Pfizer; Regeneron Pharmaceuticals, Inc; Sanofi; Stiefel/GlaxoSmithKline; Vitae; Mitsubishi Tanabe; Eli Lilly & Co; Asana Biosciences; and Kiowa Kirin; has acted as an investigator for Celgene; Glenmark; LEO Pharmaceuticals; MedImmune; Regeneron Pharmaceuticals, Inc; and Eli Lilly & Co; and participated in advisory boards for Celgene; Celsus Therapeutics; Demira; Galderma; Glenmark’ MedImmune; Novaris; Pfizer; Regeneron Pharmaceuticals, Inc; Sanofi; Stiefel/GlaxoSmithKline; Vitae and Asana Biosciences.

Guttman E. A Novel, Oral, Selective Sphingosine 1-Phosphate Receptor Modulator, Improves Patient and Clinician Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis in a Randomized, Double-Blind, Placebo-Controlled Phase 2 study (ADVISE). Presented at the: American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX); Virtual.

Articles

A study presented at the American Academy of Dermatology Virtual Meeting Experience 2021 exhibited new safety and efficacy data for etrasimod as a potential treatment for atopic dermatitis.

Etrasimod Demonstrates New Safety, Efficacy Data for AD in Phase 2 Study

Videos

In part 1 of this video interview, Hilary Baldwin, MD, explains her findings from a recently conducted survey investigating the effects of acne on both teenagers and their parents.

The Emotional Effects of Acne on Teenagers and Parents

Mark Lebwohl, MD, discusses his recent presentation from AAD VMX 2021 regarding new data for various biologics for the treatment of psoriasis.

What's Hot in Biologics for Psoriasis?

Welcome to “Meet the Aesthetic Expert,” where, each month, dermatologist 

 of LaserAway, will connect with select industry leaders to get their expert opinion on the aesthetic specialty. With an emphasis on straightforward, candid questions, Kirby will focus on the best in aesthetics and get the experts’ frank thoughts on where the field is headed.

 is a board-certified, fellowship-trained dermatologist based in Connecticut. Already an authoritative voice in aesthetics via her clinical research, speaking, and teaching, she now furthers her reach in the industry as the just announced chief medical officer of Ideal Image, the nation’s leading medical spa.

 Dr Mraz Robinson, please let me be one of the first to congratulate you on your new title. Can you please tell us a little more about your backstory and how you got this coveted role?

Thank you so much. Becoming the chief medical officer of Ideal Image is a huge honor, and I cannot wait to help mold the landscape of aesthetics on a larger level. I have taken a little bit of a circuitous route to end up here. As an undergrad, I started off in a physician assistant program but realized that while I loved the autonomy and medical acumen it afforded me, it wasn’t the right fit for me. I went to medical school, matched at a dermatology residency, and completed a cosmetic and procedural fellowship. I stayed on at my fellowship practice for a few years before leaving and eventually opened my own clinic with my former co-resident and friend. Through the years, I have always stayed active in education through either teaching residents, training sessions with clinicians, and lecturing. What I have found in practice is that while I love building relationships with my patients and helping them achieve their aesthetic goals, I am not scalable. When the opportunity to become CMO of Ideal Image presented itself, it afforded me the perfect synergy of dedication to aesthetic education on a large scale in an environment focused on providing quality personalized care.

 Fair points. I know you are humble but let’s be honest, this is an immensely powerful position. What do you hope to accomplish in this position?

 What I am most excited about is the ability to help sculpt the future of aesthetics on a larger scale. Supporting the aesthetic space entails appropriate education, delegation, and supervision of clinicians to provide excellent quality, and appropriate level care. I realized this first in my fellowship program. There, registered nurses were trained to perform and execute laser hair removal, radiofrequency treatments, and non-invasive body contouring procedures. They were so excellent at their job given their high level of education, training, and skill. The opportunity to now support clinicians in this larger educational capacity excites me.

 Let’s get granular. Walk me through your goals in your first few months at Ideal Image.

I am a huge proponent of medical-grade skincare and look forward to partnering with respected and trusted brands to pair with procedures to give our patients the best results possible. Additionally, while lecturing, serving as a consultant to aesthetic companies, and being a primary investigator on many cosmetic trials, I keep a close eye on the up-and-coming players, products, and indications in our space. I will critically evaluate new potential devices and procedures to bring aboard.

 In your new chief medical officer role, you are going to have to play politics with our industry. I can attest to this fact because in my own CMO role I find myself playing politics nearly every day. Politics can be dirty. Are you ready for that challenge?

Absolutely. I have been interfacing with industry, colleagues, and media in varying degrees for many years. Serving as CMO affords me more visibility but does not change my beliefs nor the way I conduct business. I am a straightforward person and expect the same from my industry counterparts.

 What's the best piece of aesthetic career advice you have received?

Trust your gut. I have never regretted following these words of advice. I know this is general life advice, but I find it very applicable especially in the world of aesthetics.

 What resources are the most effective in making your life in aesthetics easier?

 I have found that using an electronic medical record system that interfaces with billing and practice management systems is invaluable. Time is my most valuable resource and having a multitude of systems that do not integrate are a waste of time, and I hate wasting time.

 What assets (technology, human resources, staff education, marketing, etc.) should aesthetic providers and practices invest in?

My most important practice resources are the people and staff I work with every day. They are my work family who keep me moving, know what I need before I need it and make me happy when I am seeing patients. Investing in my staff in terms of education and human resources to keep them engaged, stimulated, and motivated is paramount to me.

 What aesthetic patient population do you find the most challenging and why?

Patients with body dysmorphic dysmorphia [BDD] can be challenging. Based on data, we know that BDD prevalence can be up to 14% in our aesthetic patients seeking treatment. Recognizing BDD and referring the patient for appropriate therapy is imperative. I have a low threshold for telling patients that I will not treat them, and I think this is critical.

 Telehealth exploded during the pandemic. Is it here to stay? What role will it have in aesthetics moving forward?

Telehealth is absolutely here to stay. People love the ease and comfort of speaking to their provider from the comfort of their home or office. The ability to make an aesthetic treatment plan and perform follow-up visits remotely is convenient not only for the patients but also for providers and practices!

 You touched on this briefly, but I want to address it again. What role do allied healthcare professionals (RNs, NPs, PAs, etc.) play now in aesthetics and what role will they play 5 years from now?

I believe that allied healthcare providers have a quickly growing role. Estimates of aesthetic market penetration in the US are at 8 to 10% with anticipated growth in non-invasive procedures. Physician providers are simply not capable of providing all requested aesthetic services in the U.S. currently and with projected growth, the role of allied health professionals will only expand.

 So many aesthetic pharmaceutical companies and aesthetic device manufacturers quietly whisper that the ‘traditional key opinion leader’ model is dead but they always end up dipping back into that antiquated well. And we keep seeing new product launches that fail using this paradigm. Why are industry insiders so scared to abandon this fatigued KOL model and make a pragmatic change?

I have been hearing that there will be a paradigm shift away from key opinion leaders for as long as I have been practicing. But companies seem to continue to stay with hackneyed KOLs, who often speak for every company and in my opinion, have compromised credibility and thus minimal value. Apprehension remains and these companies erroneously fear that if they do not use these established KOLs and fail with a launch or a marketing campaign, it will be in part to the lack of the presence of the KOLs. That said, I do think that most aesthetic companies finally are starting to better appreciate the merit of working with a new, more diverse group of talented medical influencers who are being more selective with their industry relationships.

 Very insightful and you know I agree! Moving forward, what advice do you have for aesthetic providers to avoid burnout?

Make sure to make time and space for yourself. I have a very full and busy life, but I find I am most balanced, fulfilled, and productive when I take time for long walks to recenter.

 I’d love to play in the NBA but I’m not good at shooting, rebounding, or passing. And I’m slow… also, lazy. So, if you weren’t an aesthetic expert, what would you do for a living?

Oh, this one is easy, the 15 to 20 year ago me would have been a Rockette. I grew up dancing and always dreamed of dancing in The Christmas Spectacular! The current me is not up for high kicks anymore, but still loves movement and being active so I would be a yoga instructor!

 What’s the funniest mistake you made in your aesthetic career?

 Luckily, I made this mistake on myself. I always tell my patients to NOT do any aesthetic procedure for 2 weeks before a big event, but did I follow my own advice? Of course not! I was going to Christie Brinkley’s 60th birthday and injected PRP around my eyes. My eyes were so swollen for the event, I could barely see. it looked terrible! But it was a great reminder to heed my own advice!

 What is your favorite aesthetic treatment to personally receive?

The Cynosure Picosure Focus laser treatment. It is best the best laser treatment to keep my skin looking fresh with little to no downtime, it is a win-win!

 You have treated me with the Picosure so I believe you! As an expert in the aesthetic industry in a powerful role, people are looking at you to lead. If you could inspire a movement in our industry, what would it be?

 I want to be a strong leader, role model, and a positive female example for our industry. The vast majority of aesthetic patients and clinicians are women, yet the vast majority of aesthetic industry leaders are male. No personal offense to you of course.

 No offense taken because I agree with you – our industry should put a bigger emphasis on women! Now, we are almost done, and I’d be remiss if I didn’t address the elephant in the room so I’m just going to float it right out there: You and I now serve as the Chief Medical Officers of the two biggest purveyors of aesthetic treatments in the nation. Where does that position us? And where does this position LaserAway and Ideal Image? One could argue that we are competitors, but I see it completely differently. To me, a rising tide lifts all boats and there is significant synergy in what our two groups are trying to accomplish. But maybe I’m wrong. Your thoughts?

 A rising tide definitely lifts all boats! I know that that you and I, both as representatives of our respective companies and as industry pioneers, are completely aligned in providing safe and effective aesthetic treatments nationwide. I look forward to forwarding our industry through the thorough mutual exploration of each and every future opportunity, including research, publications, speaking events, and educational outreach.

 Smart answer, Dr Mraz Robinson. I was ready for a street fight! But seriously, thank you so much for taking the time to chat with me today. Our discourse makes me realize that the future of aesthetics is in good hands. How can readers get more aesthetic expert information from you?

Please follow me on Instagram at @deannemrazrobinsonmd

In this special edition of our "Meet the Aesthetic Expert" column, Will Kirby, DO, FAOCD, talks with board-certified, fellowship-trained dermatologist Deanne Mraz Robinson, MD, about her just announced role as chief medical officer of Ideal Image, the struggles regarding BDD patients, and the expanding role of allied healthcare providers.

Meet the Aesthetic Expert With Dr Will Kirby: Deanne Mraz Robinson, MD

William Damsky, MD, PhD, assistant professor of dermatology and pathology at Yale School of Medicine, New Haven, Connecticut, spoke on a recent trial (NCT03910543) which evaluates tofacitinib as a treatment for sarcoidosis at the American Academy of Dermatology Virtual Experience 2021 (AAD VMX 2021).

Cutaneous sarcoidosis is an idiopathic inflammatory disorder that is most common among Black women. About 1 in 25 Black women will develop this disorder during their lifetimes. As many as 4,000 deaths per year are either directly or indirectly attributed to sarcoidosis. It affects almost every organ, including the lungs and lymph nodes, which are most common, but also heart, eyes, and other areas of the body. Approximately one-third of patients experience skin-related symptoms.

In a preclinical trial, a patient tested was a 48-year-old female with 8 years of both pulmonary and cutaneous sarcoidosis. About 15% of her body surface area (BSA) was involved and multiple treatments were tested. The patient was then switched to tofacitinib 5 mg (Xeljanz, Pfizer). Tofacitinib is an oral Janus kinase (JAK) 1 inhibitor.

“She had a really remarkable response to therapy,” explained Damsky. “Such that her active sarcoid plaques turned into just post-inflammatory hyper-pigmentation over the period of 9 months.”

Biopsies were done on the patient’s skin before and after treatment. The patient exhibited improvement from baseline and a negative p-STAT immunohistochemistry (IHC).

Currently, there is only1 FDA-approved treatment, prednisone (Deltasone, Geneyork Pharmaceutical), but it is only intended for pulmonary sarcoidosis. Patients may also be transitioned to methotrexate or tumor necrosis factor (TNF) α blockers. 

There are many approaches for treatment of cutaneous sarcoidosis such as:

The trial was an open label study that included 10 sarcoidosis patients with cutaneous involvement, 9 of which also had active internal organ disease. Tofacitinib was administered at 5 mg twice daily for 6 months. 

Patients enrolled had to meet the following criteria: 18 years or older, be diagnosed of cutaneous sarcoidosis with supportive biopsy, Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score of 10 or greater, and if any other systemic therapies for treatment of sarcoidosis, needed to be on a stable regimen for at least 3 months. 

Primary outcomes were CSAMI change after 6 months of treatment. Patients were allowed to continue, lessen, or discontinue concomitant immunosuppressive agents while participating in the trial. Secondary outcomes included changes in internal organ sarcoidosis, quality of life metric (Skindex-16), histologic and molecular finding in skin, and molecular findings in plasma.

Baseline characteristic for those enrolled were patients in their 50s to early 60s, 6 were male and 4 were female, most had long standing disease, had failed a number of previous therapies, and had numerous different skin types.

Additional results of the study show an average reduction in CSAMI score of 82.7%. All patients saw improvement at Day 180 and 6 patients achieved a CSAMI score of 0. Most patients were able to significantly taper or discontinue their baseline immunosuppressive regimen, including prednisone. All patients completed the study, with tofacitinib being well-tolerated and no serious adverse events (SAE)s were noted, according to Dumsky.

Systemic response data and mechanistic data will be presented at a future date.

1. Damsky, W. Treatment of Sarcoidosis with Cutaneous Involvement with Tofacitinib: Results of an Open-Label Clinical Trial. Presented at the: American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX); Virtual.

According to study data recently presented at AAD VMX 2021, tofacitinib demonstrated positive results when being evaluated as a possible treatment for cutaneous sarcoidosis. 

Tofacitinib Evaluated as Possible Treatment for Cutaneous Sarcoidosis

 year medical student and researcher at Harvard Medical School in Boston, Massachusetts, presented a retrospective study on how the female sex is associated with higher rates of dermatologic adverse events (dAEs) among patients with melanoma receiving immune checkpoint inhibitor therapy (ICIs) at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021).

ICIs targeting programmed cell death (PD)-1, PD-ligand (L)1, and cytotoxic T-lymphocyte antigen 4 (CTLA-4) have become essential treatments for advanced and metastatic cancer. 

However, ICIs often instigate autoimmune-like immune-related adverse events (irAEs). Around 30-50% of patients on ICIs experience dAEs which vary in morphology and severity while causing significant morbidity and may make ICI discontinuation necessary. 

The study’s objective was to evaluate the impact of sex on the development of dermatologic toxicity in a single tertiary cancer center cohort of metastatic melanoma patients receiving ICIs. 

Inclusion criteria was comprised of all adult patients who received nivolumab (Opdivo, Bristol-Myers Squibb), pembrolizumab (Keytruda, Merck), ipilimumab (Yervoy, Bristol-Myers Squibb), or a combination of nivolumab and ipilimumab and also had consistently documented evaluation for at least every 4 weeks. These were reviewed for dAEs by the study’s investigators.

The design was a multivariate logistic regression controlling for 3 factors—age, type of ICI, and infusion cycle numbers—assessed for the impact of sex on the development of dAEs. The secondary endpoint analyzed the effect of menopausal status. This was based on prior epidemiologic studies of females 52 years and older that were classified as post-menopausal.

There were 235 patients analyzed, with 142 being male and 93 being female. Of the female subset, 27 were premenopausal and 66 were post-menopausal. 

“In comparing our female and male patients in our retrospective cohort, we found that preliminarily, female patients had an increased number of confirmed ICI associated dermatologic-immune related-adverse events [irDAEs],” Siad said.

More than 62% of females compared to about 48% of males had confirmed ICI associated dermatologic irAEs. The male group with slightly older with a median age of 65, whereas female median age was 60. Both groups were predominately White. The distribution of specific ICI and the number of ICI cycles received did not differ between groups.

It was found that the female sex was associated with twice the risk of developing dAEs, with an odds ratio (OR) of 2.11. Secondary analysis found that there was a comparable OR between premenopausal and post-menopausal women compared to men. 

“This suggests that factors beyond sex are likely contributory, such as social differences, warranting further study,” Siad explained.

Estrogen can mediate activity of both regulatory T cells and PD-1 access which are involved in the development of primary autoimmune disease and the irAEs from ICIs, according to Siad. Individuals of the female sex elicit stronger T cell-dependent immune responses and carry a higher risk for autoimmune disease compared to the male sex. 

“Clinicians should consider these findings in counseling female patients regarding their elevated risk of dermatologic-immune related-adverse events [irDAEs] from immunotherapy,” Siad concluded.

Jordan T. Said had no disclosures to report. 

1. J. Said. Female Sex is Associated with Higher Rates of Dermatologic Adverse Events Among Patients with Melanoma Receiving Immune Checkpoint Inhibitor Therapy: a Retrospective Cohort Study. Presented at the: American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX); Virtual.

A study at AAD VMX 2021 presented data on possible association between sex, skin cancer medication, and dermatologic adverse events. 

Relation Between Skin Cancer Medication and Dermatologic Adverse Events

The FDA has accepted the supplemental New Drug Application (sNDA) and set a Prescription Drug User Fee Act (PDUFA) date for apremilast (Otezla, Amgen). The FDA will decide on whether to approve the drug or not for the treatment = of adults with mild to severe plaque psoriasis on December 19, 2021.

Currently, the drug is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and adult patients with oral ulcers associated with Behçet's Disease.

"Otezla has been prescribed to hundreds of thousands of patients with moderate to severe plaque psoriasis. Based on the positive phase 3 ADVANCE data, we believe it could play an important role in addressing the unmet need for adults affected by mild-to-moderate plaque psoriasis who have had challenges managing their disease with existing topical therapies alone," said David M. Reese, MD, executive vice president of Research and Development at Amgen. "The FDA's acceptance of this sNDA for Otezla is a significant milestone toward achieving our goal of potentially providing the first and only oral treatment option for the underserved mild-to-moderate patient population."

 the sNDA acceptance is supported by data from the phase 3 ADVANCE study (NCT03721172). ADVANCE was a double-blind, multicenter, placebo-controlled trial that examined apremilast in 595 adult subjects with mild-to-moderate plaque psoriasis who were given 30 mg of apremilast or placebo twice daily for 16 weeks then followed by an open-label extension study that extended to Week 32.

Results demonstrated a positive outcome with apremilast achieving its primary endpoint of a statically significant improvement in Static Physicians Global Assessment (sPGA) response at Week 16 versus placebo. The secondary endpoints in the study were also met with a minimum of 75% improvement from baseline in percent of affected body surface area (BSA), an alteration in Psoriasis Area and Severity Index (PASI) score from baseline and a change in BSA score from baseline.

Safety was also evaluated in the study with the safety profile mimicking those in previous studies. The most common treatment-related adverse events (≥5%) include nausea, headache, nasopharyngitis, upper respiratory tract infection and diarrhea. The is consistent with previously reposted data from clinical trial programs. 

1. Amgen. FDA accepts Amgen’s supplemental new drug application for Otezla® (Apremilast) for adults with mild-to-moderate plaque psoriasis. Accessed May 6, 2021. 

https://www.prnewswire.com/news-releases/fda-accepts-amgens-supplemental-new-drug-application-for-otezla-apremilast-for-adults-with-mild-to-moderate-plaque-psoriasis-301283931.html

2. Amgen Announces Positive TopLine Results From Otezla apremilast Phase 3 ADVANCE Study In MildToModerate Plaque Psoriasis. Amgen, Inc. https://www.amgen.com/media/news-releases/2020/05/amgen-announces-positive-topline-results-from-otezla-apremilast-phase-3-advance-study-in-mildtomoderate-plaque-psoriasis/. Published May 6, 2020. 

After data from a phase 3 study, FDA opens potential for apremilast to be the first and only approved oral therapy for mild to moderate plaque psoriasis. 

FDA Accepts NDA, Sets Action Date for Apremilast

This lightweight, hydrating moisturizer is filled with peptides, sodium hyaluronate, squalane, and patented “ruby of the forest” mushroom extract. Developed using Hanacure’s proprietary nanotechnology, this moisturizer absorbs into the skin, helping to improve the appearance of the skin’s texture and tone. This formulation is safe for sensitive skin and is free of parabens, sulfates, alcohol, fragrance and phthalates.

This skin care trio fuses lactic acid and Riiviva’s Milk-Tech to simultaneously exfoliate and soothe the skin. Comprising a cleanser, toner, and hydrating cream, this kit is designed to be used in combination with Riiviva’s microdermabrasion treatments to achieve soft, glowing skin.

Summer Ready Vitamin D Promoting Sunscreen

Free from parabens, oxybenzone, nanoparticles, and para-aminobenzoic acid (PABA), this product is the first sunscreen is the US that protects the skin from both UVA and UVB light while promoting vitamin D absorption using Summer Ready’s patented (US20110268678) technology, according to the company.

Formulated with key ingredients kaolin clay and charcoal, this face mask eliminates dirt and oil while reducing the appearance of pores. This product is also packed with lecithin, a powerful humectant that helps prevent dryness and retain moisture, leaving the skin feeling smooth and nourished.

ClearBalm’s 3-step skin care system includes a gentle foam cleanser, serum hydrator, and power elixir aimed at clearing breakouts and targeting fine lines and uneven skin tone. This benzoyl peroxide-free formulation is packed with potent, plant-derived active ingredients such as hyaluronic acid, bixa orellana seed extract, niacinamide, squalene, hemp-derived CBD, and AHAs from sugar cane, bilberry, sugar maple, and citrus fruit extracts. 

Each month, Dermatology Times® features a roundup of products trending in skin care. Click here to find out what products are trending for the month of May.

What’s Trending in Skin Care? May 2021

Ellen Kim, professor of dermatology at the University of Pennsylvania, Philadelphia, Pennsylvania, presented the results from the FLASH (NCT02448381) study at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021)

The objective of the phase 3, multicenter, randomized, double-blind, placebo-controlled study was to determine the efficacy of SGX301(synthetic hypericin ointment 0.25%, Solgenix), a topical photosensitizing agent, and fluorescent bulb-light irradiation to treat patients with plaque or patch phase cutaneous T-cell lymphoma (CTCL), specifically mycosis fungoides (MF). 

MF is the most common subtype of CTCL and presents itself as patches, plaques, tumors, and erythroderma. About 70% of patients are diagnosed with early-stage disease and symptoms include itching, burning, scaling, and cosmetics disfigurement. Skin directed therapies (SDTs) are the primary treatment in early stages. The goals of therapy is to improve skin symptoms and health-related quality of life, prevent infection and disease progression, and minimize long term toxicity.

Current SDTs for CTCL include topical agents such as corticosteroids, retinoids, chemotherapy, immunotherapy, phototherapy, and radiation therapy. Most patients utilize multiple SDTs throughout their lifetimes and SDTs can be repeated as treatment, but present SDTs may have short- or long-term adverse effects (AEs) that may limit their use. 

“All CTCL physicians agree, we very much need additional safe affective therapies for our patients,” Kim said. 

Hypericin was originally derived from plants but is now made synthetically to enhance the purity and potency of the ointment. SGX301 is activated by visible light (500-650 nm) and has been previously tested as treatment for psoriasis. 

The inclusion criteria were comprised of patients 18 years or older in stage 1A, 1B, or 11A of disease. The 169 enrolled patients were randomized 2:1 to SGX301 versus placebo and 3 index lesions were selected for treatment. SGX301 was administered to patients and then covered for 18 to 24 hours and was exposed to externally visible light twice weekly. The starting dose was 5 J/cm

 per visit until light erythema or max dose of 12 J/cm

The primary endpoint was a 50% or greater decrease in modified Composite Assessment Index Lesion Severity (mCAILS) score. These were calculated 2 weeks after each cycle. 

There were 3 cycles that included 6 weeks of treatment and 2 weeks off. In the first cycle, 118 patients were in the SGX301 arm with 5 J/cm

 and 51 were in the placebo arm. In cycle 2, all patients that achieved the primary endpoint were then treated with the 5 J/cm

 on 3 lesions until Week 16. There was then an optional cycle 3, where SGX301 was used on all subjects and all lesions. 

The study population age was 57 to 60 years old and there were slightly more male than female subjects. About 72% of patients were White and around 24% were Black. The majority of patients (62.1%) were in the 1A stage, 33.6% in the 1B stage and 4.3% in the 11A stage of disease. The median time from diagnosis was 3 to 4 years and median prior therapies were 2 to 3. 

After cycle 1, there was a 16% mCAILS response rate in the SGX301 treatment arm compared to 4% in the placebo arm. In cycle 2, all patients received SGX301 and the mCAILS response rate increased to 40%. At the end of cycle 3, 49% patients who received 3 cycles of SGX301 met the mCAILS.

During cycle 1, treatment emergent adverse events (TEAEs) happened at the same frequency between the SGX301 arm and placebo arm. Skin-related TEAEs occurred in 16.4% of SGX301 patients versus 10% of placebo patients and included pruritus, erythema, hyperpigmentation, contact dermatitis, skin burning, skin irritation, and blistering. The TEAEs were generally considered mild to moderate in severity. Serious adverse events (SAEs) occurred in 2.4% of patients but were not related to SGX301. 

The most common reason for study discontinuation was patient withdrawal of consent and lost to follow up. 

“While longer follow up is needed, hypericin based photo-dynamic therapy based on its non-mutagenic mechanism of action, should not be associated with long term actinic skin damage or increase risk of skin cancer which would be very important for CTCL patients who acquire chronic therapy,” Kim said. “And it would be a definite advantage over tradition Ultra-violet light-based therapy.”

1. E. Kim. Visible Light Activated Topical Hypericin Ointment in CTCL: FLASH Study Results. Presented at the: American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX); Virtual.

Ellen Kim received research grants from Actelion, Galderma, Innate, and Soligenix. Was a consultant or on a scientific advisory board for Actelion, Almirall, Galderma, Helsinn, and Ology. On the board of directors for the Philadelphia Dermatological Society. Former chair on the Medical Advisory Council for Cutaneous Lymphoma Foundation. Former Board of Directors for the US Cutaneous Lymphoma Foundation.

New data from a phase 3 study evaluating SGX301 for treatment of cutaneous T-cell lymphoma (CTCL) skin symptoms was recently presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX 2021).

Study: SGX301 Demonstrates Efficacy for Treatment of Cutaneous T-cell Lymphoma

The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte (TIL) therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.

“The Orphan Drug Designation incentivizes biotech companies to develop new therapies that are important for patients. We are pleased to advance development of ITIL-168 for the treatment of melanoma stages IIB to IV with this designation,” said Bronson Crouch, chief executive officer of Instil Bio, Inc.

ITIL-168 is described as an investigational, autologous cell therapy comprised of TILs. Through its manufacturing process, the treatment is designed to capture and preserve the maximum diversity of each individual’s patient’s TILs, the company stated.

Furthermore, the manufacturing process of ITIL-168 allows for scheduling flexibility for both physicians and patients at the time of tumor resection as well as TIL therapy.

In 2021, ITIL-168 is expected to be investigated in an international, phase 2 trial in advanced melanoma. The treatment will be studied in additional solid tumor indications in phase 1 studies in the beginning of 2022.

TIL therapy has been an active area of investigation in melanoma. For example, in the phase 2, international, single-arm, C-144-01 trial (NCT02360579), the TIL treatment lifleucel (LN-144) is being explored in patients with stage IIIC or IV unresectable or metastatic melanoma who have progressed on at least 1 prior systemic therapy, including a PD-1 inhibitor and BRAF or BRAF/MEK inhibition, the latter of which for patients who are 

The C-144-01 study has 4 cohorts: patients who received “first-generation” lifileucel therapy that had not been cryopreserved (cohort 1), and those who were treated with “second-generation” cryopreserved lifileucel therapy (cohorts 2-4).

 All 3 primary cohorts are fully enrolled, with cohort 3 serving as an experimental retreatment subgroup for patients in cohort 2 who experience progression following TIL therapy. Cohort 4 has been adapted so that all patients with 

 mutation–positive disease were previously treated with a BRAF or BRAF/MEK inhibitor.

After the manufacturing process is completed, the expanded TILs are cryopreserved and shipped back to the site where the patient is undergoing. Lifileucel is then administered intravenously, and then patients immediately receive up to 6 doses of interleukin 2 (IL-2).

Findings from cohort 2 were presented in 2020.

 Here, 66 patients with high baseline tumor burden who had received a mean of 3.3 prior therapies received lifileucel. At a median study follow-up of 18.7 months, the objective response rate was 36.4%; the partial response (PR) rate was 33.3% and the complete response (CR) rate was 3.0%.

Additional data showed that the stable disease rate was 43.9% and the disease control rate was 80.3%. A total 13.9% of patients experienced progressive disease. The median duration of response was not reached (range, 2.2 to 26.9+ months).

Updated results of a median 28.1 months of follow-up of the phase 2 study were presented during the virtual 2021 AACR Annual Meeting.

 The longer data showed that the ORR was 36.4% and the median DOR was still not reached (range 2.2 to 35.2+ months). The ORR comprised a 4.5% CR rate and a 31.8% PR rate.

Regarding safety, lifileucel was found to be consistent with the disease setting, lymphodepletion, and the IL-2 regimens that were utilized used, and investigators noted that the frequency of adverse events decreased over time.

This article was originally published by our sister publication 

Instil Bio receives Orphan Drug Designation for ITIL-168 in melanoma. News release. Instil Bio, Inc. April 27, 2021. Accessed April 27, 2021. 

Study of lifileucel (LN-144), autologous tumor infiltrating lymphocytes, in the treatment of patients with metastatic melanoma (LN-144). ClinicalTrials.gov. Updated January 21, 2020. Accessed April 27, 2021. 

https://clinicaltrials.gov/ct2/show/NCT02360579

Sarnaik A, Khushalani NI, Chesney JA. Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies. 

. 2020;38(suppl 15):10006. doi:10.1200/JCO.2020.38.15_suppl.10006

Chesney JA, Larkin JMG, Kirkwood JM, et al. Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: sustained duration of response at 28 month follow up. Presented at: 2021 AACR Annual Meeting; April 10-15, 2021; virtual. CT008.

The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.

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Study: SGX301 Demonstrates Efficacy for Treatment of Cutaneous T-cell Lymphoma

FDA Grants Orphan Drug Status to ITIL-168 for Melanoma

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