PracticalDermatology

We should feel great compassion for anyone with a mild to moderate case of a common skin disease, such as psoriasis, acne, or atopic dermatitis. Not only do they have a chronic condition that greatly impacts their quality of life, but there is also something they don’t have: access to the most innovative treatments.

Psoriasis and atopic dermatitis differ in important ways, but both cause itchy or painful patches of skin and can lead to emotional and psychological struggles. But unless patients are classified as having reasonably severe disease, they will be denied access to the remarkable new antibody drugs that can effectively dampen their over-active immune reactions. Instead, they must rely on outdated, mostly topical treatments.

As good as the newer biologic and systemic therapies are, the reality is that very few patients actually benefit from them. According to data from the health care research firm Decision Resources Group, less than 10 percent of psoriasis patients were being treated with an antibody therapy in 2020, and only around one percent of atopic dermatitis patients received such a drug to manage their disease. Yet, well over 90 percent of patients with both conditions were receiving older topical treatments, such as steroids, vitamin D analogues, or calcineurin inhibitors.

People with acne are not any better off. Like psoriasis and atopic dermatitis, acne can cause significant psycho-social burden. Also, like psoriasis and atopic dermatitis, the most effective therapy (isotretinoin) is reserved for only the most severe cases, due to safety concerns.

These older drugs aren’t necessarily bad, but as dermatologists know well, current topical options for diseases such as psoriasis, acne, and atopic dermatitis often require difficult tradeoffs. For example, while topical high-potency steroids can be highly effective, they carry serious risks of side effects such as striae or skin atrophy when used chronically. And while vitamin D analogues can be used for the long term, they are much less effective than steroids and frequently present issues with skin irritation.

Most Patients Left Behind

How did we end up here? It didn’t happen overnight. In the past 20 years, 12 novel biologic and systemic treatments have been approved for moderate to severe plaque psoriasis, and two more are in late-stage development. In stark contrast, at the mild to moderate end of the spectrum—which represents the vast majority of patients—the most recent FDA approval of a novel psoriasis drug was in 1993, for calcipotriene, a vitamin D analog. The situation is only slightly better in atopic dermatitis, where only two novel topical drugs have been approved in the past two decades and is even worse for similarly common skin conditions, such as seborrheic dermatitis, for which the most recent novel topical was approved in 1981. In acne, there has only been one treatment with a novel mechanism of action approved in nearly four decades.

Without question, another significant factor that shaped today’s dermatology drug landscape is consolidation. From 2005 to 2015, there were 140 mergers and acquisitions involving US-based dermatology companies (remember Stiefel and Medicis?). Similarly, since 1992, of 20 commercial-stage “pure dermatology” drug companies, 12 have been acquired or ceased operations, and most of the rest are investing very little to nothing into R&D for innovative therapies. In the past decade, a new crop of development-stage “pure derm” companies have emerged, although a number of these have stumbled and either closed or do not have adequate financial resources.

This consolidation has led to atrophy in the pipeline of innovative dermatology treatments for the vast majority of patients who aren’t eligible for biologic or systemic therapy. For example, currently there are only three novel products in late-stage clinical trials for mild to moderate psoriasis, and nine novel products in trials for atopic dermatitis—of which four target Janus kinases or JAKs. Only one novel product is in development for seborrheic dermatitis. The situation is not terribly different for other diseases, such as acne or rosacea.

The Innovation Imperative

What is to be done? There is no simple solution to this lack of innovation in the dermatology space. But a combination of actions, taken by industry players and health care groups, could help drive change and improve the environment for dermatology innovation:

• Pharmaceutical and biotechnology companies can work harder to identify the most urgent issues and needs of dermatologists and patients—and a good first start would be to hire more dermatologists to lead their dermatology R&D efforts.
• These companies also could invest more time and money into the development of truly novel dermatology treatments.
• As novel treatments are approved, dermatologists and patients must demand that insurers provide reasonable access and reimbursement for those treatments.
• Dermatologists can publicly urge pharmaceutical and biotechnology companies to stop using dermatology as a “cash cow” for profits, and instead reinvest their gains in expanding their pipeline with treatments that solve real patient problems.

These changes can’t happen soon enough. We know it takes an average of about 10 years for a drug to complete the development process, and that nine in 10 drugs entering the clinic will fail to win regulatory approval. Steps taken today will not produce results for many years, so we must get moving. In the meantime, patients are waiting and suffering. As a specialty, we need to feel this sense of urgency more acutely and step up to address the innovation imperative in dermatology. Companies that fail to do so are turning their back on the very patients they say they want to help.