Topical Management of Atopic Dermatitis and Psoriasis: Clinical Insights for Dermatology PAs and NPs
Director Clinical Research
Henry Ford Health System
Adjunct Clinical Professor, Dermatology
Touro University Nevada
Topical corticosteroids were once the mainstay of treatment for atopic dermatitis (AD) and psoriasis. Now, there are several non-steroidal topical therapies with proven efficacy and safety. In this session, James Q. Del Rosso, DO, and Linda F. Stein Gold, MD, give a thorough overview of these treatments and how to incorporate them into your practice. These include ruxolitinib 1.5% cream, a JAK inhibitor approved for mild to moderate AD in patients 12 and older, tapinarof 1% cream, an AhR-modulating agent approved for plaque psoriasis in patients 18 and older, and roflumilast 0.3% ream, PDE-4 inhibitor approved for plaque psoriasis in patients 12 and older.
Drs. Del Rosso and Stein Gold begin by reviewing several real cases where these medications made a dramatic difference for their patients. In particular, they discuss whether these non-steroidal topical therapies work quickly enough to be used as monotherapy. They show that with tapinarof 1% once daily monotherapy, patients experienced significant reductions in both itch and PASI score. Overall, in the two phase 3 pivotal trials, 35.4% and 40.2% of patients on tapinarof 1% once daily achieved an investigator global assessment (PGA) of 0 or 1 with at least a 2-point improvement, compared to 6.0% and 6.3% of patients on placebo, respectively. Importantly, they note that tapinraof was well tolerated and had a benign safety profile, even when applied to intertriginous areas. The most common adverse effects (AE) were folliculitis, contact dermatitis, headache, pruritus, and dermatitis.
Drs. Del Rosso and Stein Gold then present phase 3 clinical trial data for roflumilast 0.3% cream. In the parallel trials, 42.4% and 37.5% of patients on roflumilast achieved the primary endpoint of IGA success at week 8, defined as clear or almost clear skin with at least a 2-point IGA improvement, compared to 6.1% and 6.9% of patients on placebo, respectively. Notably, roflumilast was very effective for typically hard-to-treat intertriginous areas, with 71.2% and 68.1% achieving IGA success at week 8. Roflumilast was also well tolerated, with very low rates of application site reactions and no treatment-related serious adverse events.
Finally, Drs. Del Rosso and Stein Gold switch gears and discuss the efficacy and safety of non-steroidal topicals for AD. We know that the itch-scratch cycle can be very debilitating for patients with AD, so quick and effective treatment is critical. Dr. Del Rosso discusses a case of a 15-year-old student who failed multiple topical agents but achieved significant improvement in her itch after just two days of twice daily ruxolitinib 1.5% cream. This isn’t uncommon, as Dr. Stein Gold points out that 11.2% of patients achieved a 4-point improvement in itch after just 36 hours and 30.4% of patients achieved a 4-point improvement after 7 days in the pivotal trials. Additionally, up to 53.8% of patients on ruxolitinib 1.5% cream achieved IGA of 0 or 1 with at least 2-point improvement compared to just 15.1% on placebo. They close the session by discussing exciting new data for tapinarof cream and roflumilast cream for AD.