By Denise Mann, MS
In 2023, dermatologists and their patients welcomed new drugs for acne, psoriasis, alopecia areata, and more, and 2024 promises to deliver real-world data on these medications along with even more therapeutic innovations across the spectrum of cutaneous diseases.
The Dermatology Digest asked key thought leaders and editorial advisory board members to take out their crystal balls and weigh in on what’s to come in 2024 and beyond.
Pso Far, Pso Great
“High-dose risankizumab (Skyrizi, AbbVie) induces one-year remission in early psoriasis and may be a cure,” says George Martin, MD, a dermatologist in Kihei, HI, and the Founder of Maui Derm Conference Series. This knock-out phase 2 data, which was presented by Andrew Blauvelt, MD, MBA, an Investigator at Oregon Medical Research Center in Portland, made a huge splash at Maui Derm Hawaii 2024.
Bimekizumab (Bimzelx, UCB) is finally approved for psoriasis, and the psoriatic arthritis data is “VERY good,” Dr. Martin adds.
Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in San Diego, CA, says that more psoriasis patients will see improvements in their condition due to the influx of new agents and biosimilars on the market.
“For those with severe psoriasis, I think bimekizumab and risankizumab (Skyrizi, AbbVie) will have the most impact,” he says. “For those with mild psoriasis, I think roflumilast cream 0.3% (Zoryve, Arcutis) and tapinarof cream 1% (Vtama, Dermavant) will have the most impact, especially for those patients who are trying to stop or lower their use of topical steroids.”
The innovation will keep on coming in psoriasis, adds Jason Hawkes, MD, MS, a dermatologist in Rocklin, CA.“Psoriasis is also undergoing a revolution with the development of new oral treatments that act like injectable biologics, and this is of interest to patients who do not want a shot,” he says. “One exciting interest is the idea that small molecules can get into the joints better which might finally improve our ability to treat psoriatic arthritis as well as the psoriatic skin!”
Apogee Therapeutics has developed technology that can extend the half-life of existing medications so that they are given once every 3, 6, or 9 months instead of bimonthly or monthly while also maintaining the same level of disease clearance. “This will be a game-changer if it pans out and may get us closer to disease cures via optimization of existing biological therapies,” he says.
And the Skin Disease of the Year Is….
The skin disease of the year will be… “a tie between hidradenitis suppurativa (HS) and chronic urticaria,” predicts Ted Rosen, MD, a Professor of Dermatology at Baylor College of Medicine in Houston and the Medical Editor of the Dermatology Digest.
“We will have, for sure, one new biologic and possibly one new oral medication for HS,” he predicts. “We will, for sure, have new medications for chronic urticaria.”
Dr. Martin agrees. There’s lots of excitement about remibrutinib (Novartis), an investigational Bruton’s tyrosine kinase (BTK) inhibitor, for chronic spontaneous urticaria, he says. “It has great efficacy and safety and is oral… [This means] no shot and no risk of anaphylaxis.”
For HS, Secukinumab (Cosentyx, Novartis) is approved, and the bimekizumab phase 3 data are “VERY strong,” Dr. Martin says.
“We will see a tsunami of data and drug approvals in urticaria, specifically CSU,” echoes Dr. Hawkes. “Dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc., and Sanofi) and remibrutinib will almost certainly be the first approved, so we will have a new biologic and a first-in-class oral pill for urticaria,” he says,
“HS is in its explosion right now, and there is a ton of need here.”
Inside the Burgeoning AD Pipeline
AD is another dermatologic condition that is undergoing a transformation in terms of treatment options and paradigms.
“The BIG story is Janus kinase (JAK) inhibitors,” Dr. Martin says. “Upadacitinib’s (Rinvoq, AbbVie) 5-yr safety data show that it is REALLY SAFE and effective in AD, and abrocitinib (Cibinqo, Pfizer) is safe as well.”
Peter Lio, MD, a Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University Feinberg School of Medicine and a partner at Medical Dermatology Associates of Chicago, agrees that it is going to be a big year for eczema patients and the doctors who treat them. “I like to call it the virtual cycle of drug development: we learn about a condition, get better treatments, which in turn teach us more about the condition,” he tells TDD.
“We’re raising the ‘treat to target’ higher than ever before and getting more patients clear and symptom-free than I have ever seen with new powerful systemic agents,” he says. “At the same time, we have more non-steroidal approaches than ever before, which is music to many patients’ ears.”
What’s next? “We will likely soon have a new topical phosphodiesterase inhibitor for eczema as well as an aryl hydrocarbon receptor modulator (roflumilast and tapinarof, respectively), both of which are currently approved for psoriasis but are being actively studied for eczema.”
New systemic agents and even new concepts in the prevention of atopic dermatitis and the microbiome seem just around the corner too, Dr. Lio says.
“We will see lebrikizumab (Eli Lilly), probably another JAK, and possibly nemolizumab (Galderma) for AD,” predicts Dr. Rosen.
Hands Up for New CHE therapies
Chronic hand eczema (CHE) will also get some love in 2024. The U.S. Food and Drug Administration (FDA) recently OKed a label update for dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc., and Sanofi), adding efficacy and safety data for people aged 12 years and older with atopic dermatitis (AD) and uncontrolled moderate-to-severe hand and/or foot involvement.
Leo’s delgocitinib cream, an investigational potential first-in-class topical pan-Janus kinase inhibitor, is also showing tremendous promise for moderate to severe chronic hand eczema in adults. “Every dermatologist sees hand eczema day in and day out and to have a specific medication approved for hand eczema would be incredible,” says Christopher Bunick, MD, PhD, an associate professor of dermatology at Yale University in New Haven, CT, about the promise and potential of delgocitinib cream.
Taking Seb Derm Seriously
The U.S. Food and Drug Administration (FDA) gave its nod to topical roflumilast foam (Zoryve, Arcutis) for seborrheic dermatitis in late 2023.
“The talk of the clinic right now is roflumilast foam for seborrheic dermatitis,” Dr. Bunick says. “It’s a huge thing because steroids, topical calcineurin inhibitors, and antifungals don’t work very well, the results they produce are temporary, and the disease comes back,” he says. “The data on roflumilast foam are incredible,” he says. “I am excited to see the real-world experience for roflumilast foam in seborrheic dermatitis.”
New Thinking About cSCC
Cutaneous squamous cell carcinoma (cSCC) is an ongoing public health problem as it is the second most common cancer, says Aaron S. Farberg, MD, Chief Medical Officer and Founder at Bare Dermatology in Dallas and Assistant Professor at the University of North Texas Health Science Center in Fort Worth. “As dermatologists, we can identify these cancers early which provides the best opportunity for treatment,” he says. “However, there are many people who die from cSCC and we need to spend more effort in developing improved risk stratification for these patients so we can best align our current treatments.”
Current guidelines and gene expression profile testing offer the best chance to make the right risk-aligned decisions with patients. “Immunotherapy including cemiplimab (Libtayo, Regeneron Pharmaceuticals) has also brought hope to even the most difficult tumors,” he says.
Other potentially hot topics in skin cancer in 2024 and beyond may be the personalized mRNA Moderna vaccine for melanoma and intralesional PD-1 therapy for cSCC, adds
Vishal Anil Patel, MD. He is the Director of Cutaneous Oncology at the George Washington (GW) Cancer Center, Director of Dermatologic Surgery at the GW Department of Dermatology, and an Associate Professor of Dermatology & Medicine/Oncology at George Washington University School of Medicine & Health Sciences in Washington, DC.
Acne Takes Center Stage
Cabtreo (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide, Ortho Dermatologics) for acne was among the most anticipated drug approvals of 2023.
“This three-in-one acne topical has had the best clinical data yet in terms of clearance of inflammatory and non-inflammatory lesions, and we will continue to see real-world experience with Cabtreo in 2024 and beyond,” says Dr. Bunick.
There are other exciting happenings in acne as well, says Adam Friedman, MD, Professor and Chair of Dermatology at George Washington School of Medicine and Health Sciences in Washington, DC. “I am excited for the impact of the FDA-enacted iPledge changes to be actualized, as this will result in less burden, time, cost, and negative Yelp reviews for all those involved.”
Eye on Congenital Ichthyosis
Leo Pharma recently acquired Timber Pharmaceuticals and TMB-001, a topical isotretinoin formulation for the treatment of congenital ichthyosis (CI).
TMB-001 was granted Fast Track Designation in April 2022 and Breakthrough Therapy Designation in May 2022 by the FDA. “This topical is different than other failed formulations of isotretinoin because it has a new vehicle and delivery system,” says Dr. Bunick who is conducting the clinical trials on TMB-001.
If approved, TMB-001 will be a game-changer, Dr. Bunick predicts. “Congenital ichthyosis patients have been suffering for a long time with itch, scaling, redness,and infections, and there is no FDA-approved medication for them.”
“An FDA-approved drug in an orphan disease like congenital ichthyosis is a testament to our industry,” he says. “This will become a very talked about and important medication for dermatologists in the next year and a half,” he predicts.
Dermatology in 2024 and Beyond: The Best Is Yet to Come
Gazing into his crystal ball, Dr. Friedman says, “I am hopeful we will see a continued trend of multiple systemic agents for chronic inflammatory diseases being FDA approved in unhindered succession, and even more likely lateral label extensions for disease states that aren’t overburdened with treatment options, such as hidradenitis, lichen planus, and cutaneous lupus.”
Mark G. Lebwohl, MD, the Dean for Clinical Therapeutics at the Icahn School of Medicine at Mount Sinai and Professor and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, in New York City, predicts “progress in the management of vitiligo, new oral therapies for psoriasis, more indications for Jak inhibitors, and more treatments for inflammatory skin diseases, like alopecia areata, hidradenitis suppurativa, and pyoderma gangrenosum.”
There are other unmet needs in dermatology that should be addressed in coming years including more data on the safety of existing medications in pregnancy/lactation, and the development and validation of biomarkers of disease for Psoriasis, AD, HS, and others that actually PREDICT that a patient will respond to an existing therapy and those that predict the development of disease comorbidities including plaque psoriasis patients getting psoriatic arthritis; AD patients getting asthma, urticaria, or prurigo nodularis, Dr. Hawkes says. Biomarkers will “lead to the need for PERSONALIZED and PREVENTATIVE medicine, rather than reactive medicine after you get diagnosed with a disease,” he says. “This is the future.”
