2022 Game Changers: Watch-worthy Drugs, Devices, and Technology

Dermatology Times, Dermatology Times, January 2022 (Vol. 43. No. 1),
Pages: 31

The new year promises to be rich with dermatology game changers following a sluggish 2021 for breakthroughs and FDA approvals.

There are important drug approvals looming in 2022 that could change the landscape of options for people with atopic dermatitis (AD) and psoriasis, according to Christopher G. Bunick, MD, PhD, associate professor of dermatology at Yale University and member of Dermatology Times®’ editorial advisory board.

The FDA’s approval of the biologic bimekizumab (Bimzelx; UCB) was delayed in 2021. The interleukin (IL)-17 inhibitor for plaque psoriasis and psoriatic arthritis blocks IL-17 A and IL-17 F cytokines.

“Bimekizumab was off the charts in clinical trials in terms of patients that experienced and maintained a PASI [Psoriasis Area and Severity Index] 100 score,”Bunick said.“It really redefines the ability to achieve PASI 100 in patients, and I think this medication is going to be well received in psoriasis. It works quickly, is very durable and powerful.”

Janus kinase (JAK) inhibitor deucravacitinib (BMS-986165; Bristol Myers Squibb), a novel, oral, selective tyrosine kinase 2 (TYK2) inhibitor, might see an approval in 2022, according to Bunick.

“This is a game changer because it is the first major new oral agent for psoriasis in years, joining commonly used methotrexate and apremilast [Otezla; Amgen],” Bunick said.“I think it has the potential to be the best of all of them. That’s why people are paying attention.”

JAK inhibitors remain a hot topic in dermatology. Long prescribed for rheumatoid arthritis, JAK inhibitors are new to dermatology, with an approval only last year for ruxolitinib (Opzelura; Incyte), a topical JAK for AD.

The FDA recently decided to add a black box warning on the drug class based on data showing elevated cardiovascular and cancer risks in rheumatoid arthritis patients.

“This has somewhat diminished the excitement and the breadth of how JAK inhibitors will be used in dermatology,” Bunick said. “Whether that’s right or wrong is a different debate. Dermatologists have a good history of working with medications that have black box warnings, and I don’t think that dermatologists shy away from that.” Ultimately it will depend on whether patients are comfortable taking JAK inhibitors once they have discussions with their dermatologists about risks vs benefits, according to Bunick.

In AD, the big news in the drug pipeline is the potential 2022 approval of tralokinumab (Adtralza; LEO Pharma), a human IgG4 monoclonal antibody. “It is a biologic injectable medication—an IL-13 inhibitor,” Bunick said.

Dupilumab (Dupixent; Sanofi and Regeneron Pharmaceuticals) is the only approved biologic option in AD. “Not every patient responds or has a durable response to dupilumab,” Bunick said. “So having a second biologic in the [AD] space is essential for patient care.”

Pfizer developed abrocitinib, a pipeline JAK1 inhibitor for AD, which is under FDA priority review. "Abrocitinib could be really effective but, again, the question comes back to the black box warning, what patients are going to be right for this medication and which patients are going to be OK taking it,” Bunick said.

Think Disease Modification

Emma Guttman-Yassky, MD, PhD, system chair and professor of dermatology at Icahn School of Medicine at Mount Sinai in New York, New York, spends her days researching pipeline dermatology medications and devices and caring for patients with life-altering skin diseases, including AD. What excites her most about the future is the possibility of disease modification, or treating moderate-to-severe skin diseases, then stopping a drug without having the disease return.

“Right now, when we stop treatments for patients who have moderate to severe disease, the disease comes back quite rapidly, usually by 4 to 6 weeks,” Guttman-Yassky said.

OX40 antagonist is 1 drug initiating phase 3 trials with the potential for disease modification, according to Guttman-Yassky.

Anti-OX40 (KHK4083) maker Kyowa Kirin announced phase 2 results in February 2021 for its international study of 274 patients with moderate to severe AD, according to a February 18, 2021, company news release.

“The study’s primary endpoint was week 16, but they treated patients for 36 weeks, then followed patients for an additional 20 weeks off drug,” Guttman-Yassky said. “They found that with the 2 highest doses, they were able to maintain Eczema Area and Severity Index (EASI) 75 responses in about 90% patients for another 20 weeks. I have seen some patients at Mount Sinai clear for 6 months.”

An anti-CCR4 oral medication was shown in a small study to have potential for disease modification in AD patients. CCR4 is a chemokine receptor highly expressed by Th2 cells. AD patients took the drug for 4 weeks, then stopped and not only maintained results for another 2 weeks but continued to improve, while the placebo group worsened, according to Guttman-Yassky (Bissonnette R et al EADV 2021).

“We need additional studies, but this intrigued me since CCR4 is part of a similar pathway as OX40,” Guttman-Yassky said.

Strides in Precision Medicine

Mindera Health dermal intelligence might make a splash in the US market in 2022, according to Bunick.

“This company is personalizing dermatologic medicine,” he said. “Right now, when dermatologists prescribe biologics or medications, it is kind of a trial-and-error approach.”

Mindera Health takes a piece of the surface of the skin and uses genetic, transcriptomic, and other analyses to extract a patient’s RNA, DNA, and proteins. 

“They are basically analyzing at the molecular level each patient’s unique signature and predicting from that signature which medication may work best for the patient,” Bunick said. “This is going to change how dermatologists work in the clinic, potentially for many different diseases.”

Innovative Aesthetic Technologies, Devices

A gamechanger for Miami, Florida, dermatologist Jill Waibel, MD, is the Ellacor micro-coring device by Cytrellis.

“Micro-coring is not an energy device; it is an excisional technology,” Waibel said. “Basically, the genius for this is that we can do something that is easier than a face-lift for skin laxity, including jowls. These are tiny micro-excisions that remove small cores of skin. When you remove these tiny skin cores, they biomechanically close immediately. The cores are so small—30 to 70 microns. That is below the level that causes a scar.”

The FDA recently approved Ellacor, developed by dermatologist Rox Anderson, MD, for reduction of severe wrinkles in the mid to lower face and submental area.

“[T]he FDA doesn’t really validate laxity. But I use Ellacore for laxity,” Waibel said. “The treatment takes 14 to 20 minutes. The channels close in about 2minutes and there is a little redness and pigment for about three days.”

Waibel said she has seen impressive results using the device on the lower face and neck as well as to treat tattoos, stretch marks, and acne scars.

“The limitation is that it is not a stand-alone treatment,” Waibel said. “I do a lot of this in combination with resurfacing, where I can tighten the skin and get rid of the wrinkles.”

What’s New and Coming in Acne, Rosacea, and More?

Dermatologists might soon have an energy-based device option to treat acne, according to Waibel.

Rox Anderson and dermatologist Emil Tanghetti, MD, developed the Accure laser, which is in the process for FDA approval.

In 1 study, Accure treatment resulted in an average 80% lesion reduction at 3 months post treatment.1

“Acne patients do not want antibiotics, and we probably shouldn’t be prescribing antibiotics because of their side effects. An energy-based treatment is exciting and that will happen in 2022, certainly with this laser leading the pack,” Waibel said.

A new technology that is working “surprisingly well” for the generalized flushing of rosacea, the pigment of melasma, and more is the Sylfirm X (distributed by Benev) radiofrequency (RF) microneedling device, according to Houston, Texas–based cosmetic and dermatologic surgeon Suneel Chilukuri, MD.

Dermatologist-developed Sylfirm X is a dual wave technology that has a shortwave as well as a continuous wave pulse. It is the only device in the RF microneedling category that has a short pulse wave, according to Chilukuri.

Sylfirm X uses a unique bipolar uninsulated needle, eliminating the safety concerns noted with prior-generation uninsulated RF needles. In addition, the controlled depth of penetration is different from that of every other device in this technology space, he said.

“By utilizing a depth of only 300 microns with a short pulse, we are able to improve the dermal-epidermal junction. The basement membrane gets tighter so there is less trans-epidermal water loss, which helps with rosacea. In addition, there is remodeling of the superficial vessels with subsequent clinical erythema reduction. With melasma, this short pulse activates the senescent fibroblasts in a safe manner. Clinical trials have shown that areas of hyperpigmentation in melasma have more senescent fibroblasts than surrounding areas,” Chilukuri said.

The Sylfirm X is also an integral part of Chilukuri’s C-Lift, a nonsurgical face lift technique.

“We are also using it in a procedure called vectoring, which is re-fusing the skin to the fibroseptal network and the SMAS layer. We have been treating patients with this for about 10 months now and really seeing great, long-lasting results,” Chilukuri said. “The best part is this device is safe to use in all skin types.” 

Disclosures
Waibel has done clinical trials for AbbVie, ArgenX, Cytrellis, Eli Lilly and Company, Lumenis, Lutronic, Michelson Diagnostics, Novartis, Pfizer, Regenxbio, Sciton, Syneron/Candela, and UCB. She has been on advisory boards for Cytrellis, Dominion Aesthetic Technologies, and Sciton, and a speaker for Eli Lilly and Company, L’Oréal, Novartis, and Syneron/Candela. She has received Equipment from Michelson Diagnostics.

Guttman-Yassky is an employee of Mount Sinai and has received research funds from AbbVie, Celgene, Eli Lilly and Company, Janssen, MedImmune/AstraZeneca, Novartis, Pfizer, Regeneron, Vitae, Glenmark, Galderma, Asana BioSciences, Innovaderm, Dermira, and UCB. Guttman-Yassky is also a consultant for Sanofi-Aventis, Regeneron, Stiefel/GlaxoSmithKline, MedImmune, Celgene, Anacor, Anaptys Bio, Dermira, Galderma, Glenmark, Novartis, Pfizer, Vitae, LEO Pharma, AbbVie, Eli Lilly and Company, Kyowa, Mitsubishi Tanabe, Asana BioSciences, and Promius.

Chilukuri has worked as a consultant and speaker for Aerolase, Allergan Aesthetics, Bellus, Benev, BTL Aesthetics, Eclipse, Galderma, InMode, Lutronic, Merz, PCA Skin, Revance, Sinclair, Sente, Skin Medica, Theravant, Under Skin, and ZO Skin.

Bunick is a consultant/adviser for Almirall, LEO Pharma, Sanofi/Regeneron, Skinosive, and UCB. He also is a speaker for UCB and Almirall and has been a research investigator for Almirall.

Reference:

1. Tanghetti, E., Geronemus, R., Bloom, B., Anderson, R.R., Ross, E.V., Sakamoto, F.W. Safety and Efficacy data in a pilot study of the treatment of acne with a fiber laser. Poster accepted for presentation at: 40th ASLMS Annual Conference; 2020 April 29 - May 3; Phoenix, AZ, USA.