PracticalDermatology

The sun was bright, and the science was hot at Maui Derm 2024, held at the Grand Wailea Resort in Maui, Hawaii. From new therapies to innovative techniques to treatments in the pipeline, presenters and attendees were eager to share updates and findings at this popular annual event.

Important FDA Approvals in 2023 Lead to New, Exciting Treatments in 2024

By Eric Raible, Managing Editor

A slew of big approvals for new therapies in 2023 has strengthened the armamentarium for dermatologists treating many conditions going into 2024, according to an opening presentation at Maui Derm 2024.

In what has become a popular annual tradition at Maui Derm, Practical Dermatology® Chief Medical Editor Neal Bhatia, MD, a dermatologist practicing in San Diego, and Ted Rosen, MD, a professor of dermatology at Baylor College of Medicine in Houston, donned their best newscaster costumes and delivered a sweeping update on new FDA-approved therapies for a variety of conditions. Highlighting what Dr. Rosen called an “incredible year for FDA approvals,” the presenters showcased many newly available and emerging therapies for conditions such as acne, seborrhea, molluscum, hidradenitis suppurativa (HS), and more.

Acne

Prominent among the new approvals was that of the triple combination therapy CABTREO, approved in October 2023. Particularly interesting, according to Dr. Rosen, were the results of a phase 2 study in which the triple combination therapy of clindamycin phosphate 1.2%, adapalene 0.15%, and benzoyl peroxide 3.1% outperformed all dual therapies for the study measure of clear/almost clear. The phase 3 study indicated that the triple combination therapy performed better than vehicle for the percent reduction in inflammatory and noninflammatory lesions.

“In fact, every way you look at it, the triple combination therapy did better,” Dr. Rosen said.

Seborrhea

For the treatment of seborrhea, the presenters highlighted the newly approved ZORYVE FOAM (roflumilast 0.3%). The pivotal study, evaluating roflumilast 0.3% once daily for 8 weeks (applied to the primary sites of the scalp, face, and ears), showed an achievement of treatment success in 80% of patients (versus 59% for vehicle).

Ted Rosen, MD, and Neal Bhatia, MD, operating as chief correspondents for the Maui News Network, deliver their annual themed presentation at Maui Derm highlighting important new FDA approvals for a variety of skin conditions, as well as a sneak peak into the future for therapies in development.

“Many patients actually achieved complete clearance with both erythema and scaling, which was nice,” Dr. Bhatia said. “The best part about the foam is they like the effect, putting it on surface areas that are difficult to treat, especially with a foam. So we have some good options here.”

Molluscum Contagiosum

The highlighted therapy for molluscum was cantharidin 0.7% (YCANTH, Verrica Pharmaceuticals), approved in July 2023 in adults and children 2 years of age and older. It can be applied accurately by a health care professional in the office once every 3 weeks at one drop per lesion with a specially designed precision applicator.

“There is erythema (45%) and vesiculation (95.5%), which is supposed to happen,” added Dr. Rosen. “It is mild to moderate.”

The other therapy for molluscum the presenters highlighted was berdazimer 10.3%, a newly approved, first-in-class, topical, controlled nitric oxide-releasing medication. In the B-SIMPLE4 trial, the primary endpoint of complete clearance of all lesions at 12 weeks was 32.4%. The secondary endpoint of the proportion of patients achieving a lesion count of 0 or 1 was 43.5%, and the proportion of those achieving 90% or greater clearance at week 12 was 43.0% (all P<0.0001).

Hidradenitis Suppurativa

The interleukin-17 (IL-17) inhibitor secukinumab (Cosentyx), approved in October 2023, was effective for treating HS in a population of more than 1,000 adults with moderate-to-severe HS in two phase 3 placebo-controlled trials (the SUNSHINE and SUNRISE studies). Patients with five or more abscesses, fewer than 20 fistulae, and disease present at 1 year were treated with 300 mg weekly for 5 weeks and then every 4 weeks (with increased frequency to every 2 weeks if necessary). They were then assessed at 16 and 52 weeks. The results showed the therapy was superior to placebo.

“We really don’t want to see these patients back,” Dr. Bhatia said. “The good news is that we can keep these patients off antibiotics and keep them in better situations for themselves with even more improvements in their overall outcomes, especially in those difficult-to-treat areas.”

Dr. Rosen added, “The decrease in the nodules and abscesses and the decrease in the number of flares is what we want for patients, because these are the things that interrupt their lives. We still don’t have the perfect drug, but there are more coming.”

Another HS drug in development, MC2-32 (RGRN-305), targets multiple pathways involved in HS, including the inhibition of HSP-90, which leads to the inhibition of multiple inflammatory pathways related to HS (in addition to the IL-17 inhibition). The oral therapy is currently being evaluated in a randomized, double-blind, placebo-controlled study (n = 15). The primary endpoint of HiSCR 50 was met at week 16 by six out of 10 patients in the MC2-32 group versus one out of five patients in the placebo group. The HiSCR 75 and HiSCR 90 scores were met by five and three out of 10 patients in the MC2-32 group, respectively, compared to zero in the placebo group.

“This is where you can get a pill option for those patients who are struggling with antibiotics, and now we can actually get somewhere with those who don’t want to take shots,” Dr. Bhatia noted.

Psoriasis

The big approval in psoriasis in 2023 was bimekizumab (Bimzelx) for the treatment of adults with moderate-to-severe psoriasis. The therapy works by a dual IL-17A and IL-17C inhibition pathway. The pivotal study, which saw patients given a loading dose of 320 mg and then 160 mg at weeks 0, 4, 8, 12, and 16 weeks, every 8 weeks after that (in normal-sized patients). For larger patients (≥ 120 kg), a 320-mg dose administered every 4 weeks should be considered. The risks of oral candidiasis (between 9% and 18%) were considered low, and the instances were not severe and were easily treatable. Efficacy of the drug at week 16, with a PASI of 90, was between 85% to 91%. For PASI 100 (indicating clearance) was between 59% and 68%. Out to 56 weeks, 87% to 90% of patients maintained a PASI 90 if they continued with the therapy.

“We’ve talked about bimekizumab for so many years, and it’s finally here,” Dr. Rosen said. “The bottom line is that, if you continue on the drug, you continue to improve.”

“I don’t think we’ve seen a drug where patients get better with the loading dose, which was very exciting,” Dr. Bhatia added.

Alopecia Areata

Ritlecitinib (LUTFULO), approved in June 2023 for the treatment of alopecia areata in adults and adolescents aged 12 years and older, works by inhibiting JAK-3 and TEC kinase with a 50-mg dose. The 24-week pivotal study included 718 patients with a SALT score of 50 or more.

“We saw significant improvement versus placebo,” Dr. Bhatia said. “There was a 23% improvement in SALT scores of 20 or less (80% scalp coverage), 13.4% in those of 10 or less (90% scalp coverage), and a number of patients who achieved those numbers really improved well over time. The biggest thing you need to remember is to keep these patients on it for over a year. The slow start is not a reflection on the good finish with these drugs.”

The presenters also highlighted an upcoming drug, the JAK-1 and JAK-2 inhibitor deuruxolitinib, for the treatment of moderate-to-severe alopecia areata. The drug was evaluated in the phase 3 THRIVE AA2 trial, which included 517 adults with 50% or more scalp hair loss. According to its results, 33.0% of patients taking the 8-mg dose and 38.3% of those taking the 12-mg dose saw an improvement in SALT scores compared with placebo-treated patients at 24 weeks.

“The nice thing is that we have ritlecitinib, and we are going to have deuruxolitinib, and we can do better with a larger library of drugs, just like with psoriasis,” Dr. Rosen said.

Disclosures: Dr. Bhatia reports affiliations with AbbVie, Advanced Derm Solutions, Almirall, Arcutis, Beiersdorf, Biofrontera, BMS, BI, Cara, Dermavant, Ferndale, Galderma, InCyte, Johnson & Johnson, LaRoche-Posay, Leo, Lilly, MC2, Mindera, Novartis, Ortho, Pfizer, Regeneron, Sanofi, Sun Pharma, Verrica, and Zerigo. Dr. Rosen reports no relevant interest.

Bhatia N, Rosen T. Dermatology In review. Presented at: Maui Derm, January 22-26, 2024.

Deucravacitinib Shows Sustained Response, Safety Profile: Analyses

By Eric Raible

Deucravacitinib (SOTYKTU, Bristol Myers Squibb) is a first-in-class, oral, selective allosteric TYK2 inhibitor that has been approved in the United States, European Union, and other countries for use in adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Two abstracts published at Maui Derm 2024 indicated that, not only did the drug show longer-term sustained safety and efficacy for plaque psoriasis, but it also may be useful for the treatment of lupus erythematosus.

Extension Study Shows Sustained Safety, Efficacy

Deucravacitinib was shown to be superior to placebo in the 52-week POETYK PSO-1 and PSO-2 trials in adults with moderate-to-severe plaque psoriasis. Upon conclusion of the trials, patients were offered the opportunity to participate in the PSO-1 and PSO-2 long-term extension study (LTE). Previously reported data suggested that the therapy sustained safety and efficacy through 2 years with no new safety signals.

Bruce Strober, MD, PhD, a dermatologist and clinical professor of dermatology at Yale University, kicks off the Psoriasis Update panel at Maui Derm 2024, providing updates on data for a number of drugs including bimekizumab, risankizumab, spesolimab, deucravacitinib, and more.

Researchers for the LTE randomly assigned patients 1:2:1 to oral placebo, deucravacitinib 6 mg once daily, or apremilast twice daily, with safety analyzed in those patients receiving one or more doses of deucravacitinib. According to the results, a total of 1,519 patients received one or more doses of deucravacitinib, and 513 of them received continuous deucravacitinib from day 1 in the PSO-1 and PSO-2 trials who then enrolled in the LTE. Deucravacitinib maintained its safety and efficacy though 3 years, with no new safety signals emerging.

“Since it is important to provide long-term safety for this new class of drugs, these findings provide additional support for deucravacitinib having a consistent safety profile and durable efficacy for up to 3 years of use,” the authors wrote.

VIDEO INTERVIEWS

Practical Dermatology® was on hand with a video crew at Maui Derm 2024 to speak with many presenters and key opinion leaders about a range of topics and important issues. Here are four fascinating videos from the coverage. To see more, visit: practicaldermatology.com/meeting-coverage/maui-derm-2024.

The Importance of Keeping Up with New Developments

Practical Dermatology® Chief Medical Editor Neal Bhatia, MD, chats with Beiersdorf dermMentors™ Resident of Distinction Award™–winner Dawn Queen, MD, about the need to continue to educating oneself as a practitioner and the importance of keeping on top of new drugs and therapies in daily practice. Dr. Queen is currently a resident at Columbia University Irving Medical Center.

The Latest in Hidradenitis Suppurativa

Raj Chovatiya, MD, PhD, board-certified dermatologist and clinician investigator based in Chicago, discusses the incredible pipeline for hidradenitis suppurativa, as well as new and emerging treatment options.

No Drug is 100 Percent

Jason Hawkes, MD, and Chief Medical Editor Neal Bhatia, MD, discuss how the current array of options for patients of chronic spontaneous urticaria expand treatment options for hives beyond antihistamines.

Energy-based Devices for Fat Reduction

Michael H. Gold, MD, founder and medical director of the Gold Skin Care Center in Nashville, highlights new energy-based devices for fat reduction, including those utilizing lasers and radio frequency technology for muscle stimulation.

During the Psoriasis Update 2024 session, panelist and presenter Bruce Strober, MD, PhD, a clinical professor of dermatology at Yale University, noted during his talk the potential for this new class of drug. He noted data from POETYK PSO-1 and POETYK PSO-2, pointing out that almost 2 out of 3 patients taking deucravacitinib achieved Psoriasis Area and Severity Index (PASI) of 75 at weeks 16 and 24, both significant improvements compared to placebo and apremilast.

“TYK2 inhibition holds a lot of potential beyond psoriasis and psoriatic arthritis,” he added.

Deucravacitinib for Lupus Treatment

A second abstract presented during the Late Breaking Clinical Trials session by Subhashis Banerjee, MD, disease area head at Bristol Myers Squibb, showed the results of a subanalysis of the phase 2 PAISLEY trial in which patients with active systemic lupus erythematosus taking 3 mg of deucravacitinib twice daily showed sustained improvement for the primary endpoint of Systemic Lupus Erythematosus Responder Index (SRI) response at 32 weeks and at least a 50% reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score from baseline in those with moderate-to-severe skin involvement at baseline.

Dispatches from Maui Derm Caribbean

Practical Dermatology® reached out to Jennifer C. Cather, MD, dermatologist and medical director of Mindful Dermatology in Dallas, and Joe F. Fowler, MD, dermatologist and medical director at DS Research of Kentucky, for their highlights and takeaways from Maui Derm Caribbean, held before Maui Derm Hawaii, from Jan 10-13, 2024 in Palm Beach, Aruba.

What do you think is the most important development(s) or update(s) you shared at the meeting during your talks?

Joe F. Fowler, MD: In days past, it was thought that allergic contact dermatitis (ACD) is less likely to occur in atopics due to immunologic reasons. Now we know the truth is just the opposite: at least with a number of allergens, ACD is more common in atopic dermatitis (AD) patients than the general population. Part of this is due to the greater number of potential allergens they’re exposed to in prescribed and over-the-counter topical products.

What are some best practices for assessing contact allergies in patients with AD?

JF: True test is a good start and better than not testing at all, but a more comprehensive allergen panel is better if available. Since concomitant ACD is common in AD patients, I think patch testing should be performed in the vast majority of patients before starting systemic therapies like biologics or JAK inhibitors. Sometimes finding and eliminating ACD means the remaining AD is easier to treat and may not need expensive systemic therapies.

What are some clinical concerns for dermatologists testing for contact allergies in AD patients?

JF: The JAK inhibitors will suppress patch test reactivity, so testing should always be performed before starting them. Dupilumab and similar biologics do not seem to inhibit patient reactivity very much. Patch testing should be undertaken at a time when the skin is relatively clear to avoid false positive irritant reactions.

How do food allergies play into the larger allergy picture in AD patients?

JF: Food allergy, as found by prick or RAST testing shows up a lot but is very rarely significant in AD patients. Less than 10% of infants with AD have a relevant food allergy that makes their AD worse, and the number is even lower in older kids and adults. The only time I consider food allergy to be of possible importance is if there’s a clearly documented history of ingestion followed by worsening dermatitis.

What’s a good take-home message for dermatologists dealing with contact allergies in AD?

JF: Remember that ACD is common in AD patients, so always be ready to consider this in AD patients with severe dermatitis or an atypical presentation.

Based on your presentation, what did you find most interesting about the paper on psoriasis and sleep?

Jennifer C. Cather, MD: I have seen psoriasis patients for over 20 years and have noticed that patients with psoriasis have sleep issues. I have seen deficits in their sleep quantity and in the quality of their sleep. One of my targets for treatment success is patients sleeping through the night and feeling rested. Chronic sleep impairment is an independent risk factor for cardiovascular disease¹ and it is nice to know that patients with severe psoriasis treated with appropriate systemic/biologic therapy can experience improved sleep quality.²

How does psoriasis affect sleep in patients and in families living with the condition? What is the latest information (based on the presentation)?

JC: The whole family unit is affected when one member has sleep issues—we have seen this in the pediatric AD population, and we now have data in the psoriasis population. It is important to know that not only are the children suffering but so are their parents!³

Based on your presentation, what’s new in teasing out the relationship between psoriasis and the immune systems/response or other internal systems?

JC: I can’t clear 20% to 25% of my psoriasis patients, and I have the luxury of using the best medications on the planet, so I am becoming more and more fascinated by the gut microbiome—I think this is something I do not yet understand, but it is my New Year’s resolution! We know psoriasis patients have less gut microbial diversity,⁴ and we have data rolling in that we can shift microbiomes, and it may lead to improvements in patient outcomes.⁵ Rheumatologists know a lot more about the gut microbiome than I do.

Based on your presentation, what is the latest on the impact that psoriasis has on mental health?

JC: Chronic inflammation, pain, and sleep disturbances as well as the isolation that some patients experience due to psoriasis all contribute to mental health issues we commonly see in psoriasis. Simply clearing the skin does not make emotional scars go away, so as a profession we must help patients get the appropriate counseling they need to move forward into healthier relationships, which one hopes will then allow them to reach their potentials in the workforce and in personal relationships.

Is there anything new to report, based on your slides, about any potential links between psoriasis and COVID?

JC: It is important to treat psoriasis patients appropriately with systemic and topical therapies despite COVID—you can suspend therapy for a severe infection, but do not discontinue therapy trying to avoid infection. The incidence of COVID in psoriasis patients on systemics/biologics was not different from patients on topicals.⁶

1. Spencer RK, et al. Association between poor sleep and myocardial infarction in patients with psoriasis: Findings from a cross-sectional study with the National Psoriasis Foundation. Dermatol Ther. 2023;13(11):2903-2909. doi:https://doi.org/10.1007/s13555-023-01045-4

2. Travato E, et al. Association between psoriasis, sleep, and dermatological quality of life: results of a cross-sectional study. Ital J of Dermatol and Venereol. 2023 April;158(2):140-8. https://www.minervamedica.it/en/journals/Ital-J-Dermatol-Venereol/article.php?cod=R23Y2023N02A0140.

3. Horev A, et al. Pediatric psoriasis negatively influences parental sleep quality. Ped Dermatol. 2023;40(4):610-614. doi:https://doi.org/10.1111/pde.15297

4. Lai Y, et al. Impact of gut bacterial metabolites on psoriasis and psoriatic arthritis: Current status and future perspectives. J Investigat Dermatol. 2023;143(9):1657-1666. doi:https://doi.org/10.1016/j.jid.2023.05.012

5. Buhaș MC, Gavrilaș LI, Candrea R, et al. Gut Microbiota in Psoriasis. Nutrients. 2022;14(14):2970. doi:https://doi.org/10.3390/nu14142970

6. Kwee KV, et al. Prevalence, risk and severity of SARS-CoV-2 infections in psoriasis patients receiving conventional systemic, biologic or topical treatment during the COVID-19 pandemic: a cross-sectional cohort study (PsoCOVID). J Dermatol Treat. 2023;34(1). doi:https://doi.org/10.1080/09546634.2022.2161297

For the subanalysis, patients who had SLE and a baseline CLASI score of ≥10 who had received either placebo (n = 24), deucravacitinib 3 mg twice daily (n = 23), deucravacitinib 6 mg twice daily (n = 25) or deucravacitinib 12 mg once daily were included in the analysis.

The results suggested a sustained response; more patients receiving deucravacitinib saw a sustained score of CLASI-50 for five consecutive office visits between 32 and 48 weeks (placebo, 12.5%; deucravacitinib 3 mg twice daily, 56.5%; 6 mg twice daily, 36.0%; 12 mg once daily, 58.6%). In addition, more patients achieved a CLASI activity score of 70 at week 48 than those taking placebo. Those in the treatment arms achieved CLASI-50 scores more frequently than those in the placebo group.

Disclosures: The studies covered in this article were sponsored by Bristol Myers Squibb. Dr. Strober reports being a consultant for Bristol Myers Squibb. Dr. Banerjee is an employee at Bristol Myers Squibb.

Armstrong A, Lebwohl M, Warren R, et al. Deucravacitinib in plaque psoriasis: 3-year safety and efficacy results from the phase 3 POETYK PSO-1 and PSO-2 trials. Abstract 13616. Presented at: Maui Derm, January 22-26, 2024.

Arriens C, Vollenhoven R, Gottlieb A, et al. Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) achievement and sustained response with deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in a phase 2 trial in systemic lupus erythematosus. Abstract 13629. Presented at: Maui Derm, January 22-26, 2024.