Innovation leads to a “windfall” in dermatology

Exciting developments in the treatment and management of many dermatological diseases are providing much-needed options for adult and pediatric patients with these diseases. New biologics and Janus kinase (JAK) inhibitors offer viable therapeutic choices for a growing list of dermatological diseases and conditions, including psoriasis, atopic dermatitis, alopecia areata, vitiligo and other common dermatoses.

Although the scope of skin conditions and diseases in dermatology is vast, continuous research and development has led to several breakthrough drugs to treat many common dermatological diseases.

“In the last 20 years of involvement in dermatology, I have never seen so much innovation and such deep understanding of diseases. I think we have entered the ‘virtuous circle of drug development’, where we let’s innovate and make new drugs, learn more about the disease, and then make even better drugs with more targeted actions,” said Peter A. Lio, MD, FAAD, clinical assistant professor of dermatology and pediatrics at Northwestern University. Feinberg School of Medicine, founding director of the Chicago Integrative Eczema Center and founding partner of Medical Dermatology Associates of Chicago in Illinois.

This scenario has played out over the last decade in psoriasis with the availability of ever-improving treatments. According to Lio, this virtuous circle continued and expanded to include atopic dermatitis, alopecia areata, vitiligo and acne.

Recently, new biologic drugs that block IL-13, such as tralokinumab-ldrm (Adbry) and pipeline drug lebrikizumab (Lilly), have demonstrated clinical efficacy against moderate to severe atopic dermatitis in adult patients and teenagers. Additionally, the FDA approved JAK inhibitors abrocitinib (Cibinqo) and upadacitinib (Rinvoq) in January 2022 for patients with moderate to severe atopic dermatitis and ruxolitinib cream (Opzelura) in September 2021 for mild to moderate cases. of the disease. Some of these drugs can also be given to pediatric patients, Lio said, opening the door to a number of breakthrough treatments in this patient population.

“The addition of these excellent therapeutic choices for the full spectrum of atopic dermatitis has complicated – in a good way – the treatment and management of the disease,” Lio said. “With the windfall of all these new topical and oral drugs comes a world of questions in terms of which agent to use and in which scenario. Going forward, we need to discuss medication safety with our patients and carefully determine their optimal treatment plan while understanding the risk factors for each patient.

In dermatology and, in particular, in pediatric dermatology, very few treatments are approved for the wide range of diseases. As such, many dermatologists have been relegated to living in an off-label world because they know that certain drugs that have not been approved by the FDA for an indication or age group might help their patients. According to Lio, the FDA seems to have focused more on children, so pediatric dermatology has recently benefited from the approval of new drugs for younger age groups.

“I am very happy that dupilumab [Dupixent] is now approved up to 6 months of age,” Lio said. “The hope is that we will see a number of safe and effective drugs that will be made available to a very young pediatric age group, which is extremely important for physicians who regularly see the pediatric population. “

Coverage issues

Although new therapeutic agents and drug vehicles for dermatological diseases have become available globally, insurers and health care coverage remain a major obstacle.

“Over the past two years, we have seen an explosion of new targeted drugs such as dupilumab, which is now the standard of care in most parts of the world,” said Maria Teresa Garcia-Romero, MD, MPH , President of the International Outreach and Global Alliances Committee for the Society for Pediatric Dermatology and attending physician and assistant professor at the National Institute of Pediatrics in Mexico City, Mexico. “However, in my region of Latin America, the introduction and approval of this agent and other breakthrough drugs are still in their early stages, and it can be very difficult for patients to get coverage. insurance for these highly effective therapies.”

Garcia-Romero said it typically takes 3 to 5 years for these drugs, including ixekizumab, an IL-17 blocker, and ustekinumab, an IL-12/23 blocker, to be used for psoriasis are available in Mexico and other Latin American countries. faster FDA approval for these drugs in the United States. However, once approved, pediatric patients will still have difficulty obtaining these agents due to the lack of appropriate insurance coverage.

“Accessibility to these drugs is still very difficult and most patients cannot afford these drugs themselves,” said Garcia-Romero.

“Only patients who have medical insurance or who visit hospitals where government-subsidized schemes cover the costs of therapy have access to these drugs. As in other countries, [in Latin America,] unfortunately, it is the regulatory environment that prevents patients from [receiving these drugs in a timely manner].”

In addition, many dermatological diseases and conditions still need to be treated more urgently, such as alopecia areata, vitiligo and acne, as well as genodermatoses, including ichthyosis congenita and epidermolysis bullosa, the latter having almost entirely unmet needs. According to Garcia-Romero, some of these diseases for which there are no FDA-approved drugs have been experimentally and successfully treated in recent years with biologics and other targeted therapies. However, repeated attempts to get insurance companies to cover drugs for these conditions and illnesses have failed, Lio noted, often leaving patients with the bill or with less than optimal treatment options to choose from. Lio added that this can contribute to burnout and exhaustion for clinicians and their patients when searching for optimal therapies.

And after?

“I think some of the next frontiers for new therapeutic approaches in dermatology are alopecia areata and vitiligo,” Lio said. “Although none of these diseases have a single FDA-approved treatment to date, I am optimistic that by the end of this year we will have a viable and working treatment for these common dermatological conditions, likely with JAK inhibitors in the lead.”

Lio added that as more treatment options become available, it is of paramount importance that the decision-making process regarding treatment and management is shared with the patient. Lio explained that, ideally, clinicians should present potential treatment options and review them carefully with the patient when deciding on a treatment plan. Lio said this becomes even more important when it comes to more serious medications, as patients need to be ready and willing to deal with any adverse effects that may occur during the treatment period.

“It’s a very exciting time in pediatric dermatology and adult dermatology,” Garcia-Romero said. “There are many areas of research in inflammatory disorders and genetic disorders where, over the past 10 years, we have seen more progress than in previous decades. We are getting closer to being able to treat many of the conditions we encounter every day, and we can bring lasting improvement to patients. »

Leo accepted. “We are currently in an innovation development phase, and it has been an exciting bonanza of new ideas and therapies that have recently come to light,” he said. “The next 10 years should be very interesting, and our patients will surely benefit from continued research in dermatology.”

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