Breakthroughs and disappointments of 2021


Major breakthroughs

1. FDA approval of the first topical Janus kinase (JAK) inhibitor to treat atopic dermatitis (AD). “While there were new drug and device approvals, none were truly a ‘breakthrough’ except for ruxolitinib, a topical JAK inhibitor. [Opzelura; Incyte]. This is a new small molecule drug for a skin disease that is wreaking havoc in many patients, ”said Wm. Philip Werschler, MD, founding member of Spokane Dermatology Clinic and Werschler Aesthetics, both located in Spokane, Washington.

Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University School of Medicine in New Haven, Connecticut, agreed. “I think having an FDA approved topical JAK inhibitor, even with the class that acquires the proper black box warning, is a breakthrough. This signals a new era of an entire class of drugs that has just emerged in dermatology, ”he said. “This will be a hot trendline for several years, barring any unforeseen adverse events. [AEs]. “

Patricia Farris, MD, a dermatologist at Sanova Dermatology in Metairie, Louisiana, called the topic a game-changer not only for AD, but possibly vitiligo and other conditions as well.

2. Advances in identifying and targeting abnormalities in cytokine profiles that will also reduce AEs. “One of this year’s breakthroughs for psoriasis is the demonstration that [the] roflumilast nonsteroidal topicals [ARQ-151; Arcutis Biotherapeutics] and tapinarof (GSK2894512; Dermavant) are as effective as strong steroids without local irritation or steroid [AEs]Said Mark G. Lebwohl, MD, Dean of Clinical Therapeutics and Chairman Emeritus of the Kimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai in New York, New York, adding that ongoing research on targeting various pathways could also provide new options for the treatment of alopecia areata, vitiligo, hidradenitis suppurativa and other skin disorders.

3. New drugs that tackle the root cause of skin disorders. FDA approval for a new non-antibiotic topical acne drug with a novel mechanism of action. “Clascoterone cream 1% [Winlevi; Sun Pharma] is an important new agent for the treatment of acne, ”said Ranella Hirsch, MD, president of Skincare Doctors and co-founder of Atolla (now part of Function Beauty) in Boston, Massachusetts. “Its ability to reduce sebum production by targeting androgen receptors in the sebaceous glands also results in decreased inflammation and provides a topical antiandrogen treatment option, which was previously only achieved by drugs taken orally.”

“We should see the approval of more JAK inhibitors, signaling the most significant advance in anti-inflammatory drugs since the invention of corticosteroids. We will see the expansion of biologics into other indications of diseases for which treatments previously did not have good therapies, ”said Zoe Diana Draelos, MD, assistant assistant professor of dermatology at Duke University School of Medicine in Durham, North Carolina, and chief medical editor of Dermatology Time®.

4. Non-invasive solutions for aesthetic dermatology. “[Using] ultrasound for filling complications and new filling placement techniques appear to be revolutionary steps to improve safety, ”said Matthew Elias, DO, FAAD, co-founder of Elias Dermatology in Fort Lauderdale, Fla., and new member of Dermatology Time® editorial advisory board.

5. Telehealth. “While I wouldn’t say telehealth is a breakthrough in and of itself, having been used for several years, 2021 has created breakthroughs in the way it is incorporated into practice. And, too, the technology to support it has come a long way over the past year, ”said Amy Spizuoco, DO, dermatologist / dermatopathologist at True Dermatology in New York, New York, and new member of the Dermatology Time® editorial advisory board.

“The rise of telehealth has changed the way we can interact, interact and follow patients. This has enabled a dramatic increase in contactless patient visits at their own pace and discretion, ”noted Deanne Mraz Robinson, MD, chief medical officer of Ideal Image, co-founder of Modern Dermatology PC in New York, New York, and new member of Dermatology Time® editorial advisory board.

“Telehealth hasn’t had much of an impact on my procedural practice because at the end of the day, I can’t teleport a laser pulse,” Hirsch said. “But for the patients, it was amazing to be able to access care, especially routine maintenance care, on a schedule that did not involve time off from work, did not require a babysitter and allowed much faster processing [visit] in most of the cases.”

The advent of virtual healthcare has also triggered a breakthrough in responding to the demand gap for dermatological services. “Telemedicine has become an outdated and inappropriate term,” added Will Kirby, DO, FAOCD, chief medical officer of LaserAway in Beverly Hills, Calif., And a new member of the Dermatology Time® editorial advisory board.

“Now telehealth is more precise. Only physicians can provide ‘drugs’, but dermatological diagnostic and treatment care is performed and implemented by healthcare professionals, including physicians, physicians, nurse practitioners, physician assistants and registered nurses. . Telehealth has helped patients – and some physicians – understand the value and contributions of all members of our healthcare community.

6. New technology in training, treatment and diagnosis. “There is so much on the horizon regarding the impact of technology on dermatology, with the increasing availability of less invasive technologies such as in vivo confocal laser microscopy, optical coherence tomography and US ToTo augmented reality. ultra-high resolution coupled with computer and machine vision. learn how to provide more evidence-based advice on prognosis and therapy, virtual reality training and even crowdsourcing knowledge among clinicians, ”says Albert C. Yan, MD, FAAP, FAAD, section chief of Pediatric Dermatology at the Children’s Hospital of Philadelphia in Pennsylvania and Professor of Pediatrics and Dermatology at the Perelman School of Medicine at the University of Pennsylvania.

seven. COVID-19 vaccination. “This breakthrough speaks for itself,” Elias said. More importantly, the vaccines have stemmed the impact of the pandemic on life and health, he said, adding that “they have enabled most dermatology practices, like other companies, to return to a kind of normality ”.

The biggest disappointments

1. The FDA is slow to approve oral JAK inhibitors for AD and potentially other skin disorders. “The FDA’s suspension on the approval of these drugs due to class labeling issues [AEs] is definitely disappointing, ”said Werschler.

So is the FDA’s decision to include topical AD treatments in the mandatory black box warning for oral JAK inhibitors approved to treat conditions such as rheumatoid arthritis. “It is disappointing that JAK’s first topical inhibitor carries a black box warning citing the potential risks that are typically associated with oral medications like blood clots and thrombocytopenia,” Elias said. “Patients using topical JAK inhibitors may potentially require blood monitoring, which may limit their use by dermatologists. “

2. The FDA’s decision to deny the application for a biologic license for an injectable neurotoxin, daxibotulinumtoxinA (Revance Therapeutics), to treat moderate to severe glabellar lines. The FDA’s full response letter cited factory quality control and record keeping issues for its decision. No reference was made to product deficiencies.1 “Cosmetic research has suffered a serious setback with the lack of FDA approval for daxibotulinumtoxinA,” said Joel Schlessinger, MD, founder and CEO of Schlessinger MD in Omaha, Nebraska. “That may change, but it will likely send shockwaves for companies considering toxins in the future.”

Elias added that this injectable “has the potential to revolutionize the longevity of toxin treatment for patients.”

3. FDA delays in device approval. Werschler noted that the stands on Coolsculpting Elite (Allergan Aesthetics) and a new Ulthera device (Merz Aesthetics) postponed access to advancements in body contouring and skin lifting, respectively.

4. Blockade of FDA action on bimekizumab (Bimzelx; UCB) and tralokinumab (Adtralza; LEO Pharma). “The first has really promising data for [positive outcomes for] the skin and joints in patients with psoriasis, while the latter is an essential alternative for patients who do not respond to some of the current inhibitors, ”said Bunick.

Lebwohl shares this disappointment. “Bimekizumab clearly works and is safe, but due to the pandemic its approval has been delayed for more than 6 months, and we still don’t know when it will be approved,” he said. “Deucravacitinib [Bristol Myers Squibb] shows great promise and will hopefully get approval in 2022. But the FDA delays are cause for concern.

5. The Coronavirus Aid, Relief, and Economic Security Act takes hydroquinone to 2% off the market. “This leaves us without over-the-counter hydroquinone,” Schlessinger said. “More research needs to be done on marketable pigmentation agents because of this reversal. It was a terrible decision that particularly affects patients of color and should not have happened. “

6. Evolution, not revolution. “The lack of real innovation was palpable,” said Mraz Robinson. “COVID-19 has slowed down research and has had a marked impact [negative] effect on product innovation due to past / present attention of the FDA to the pandemic. And that could hamper the pipeline further. “

“From a drug and device perspective, it’s been a disappointing year,” Werschler noted.

seven. Gaps in vaccines. “The failure of the COVID-19 vaccine to provide superior immunity after 6 months is one of the biggest disappointments of the year,” Draelos said.

Reference:

1. Revance provides a regulatory update on daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar lines. Press release. Revance Therapeutics. October 15, 2021. Accessed November 17, 2021. https://investors.revance.com/news-releases/news-release-details/revance-provides-regulatory-update-daxibotulinumtoxina-injection


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