FDA Approves New Plaque Psoriasis Treatment

A topical foam product combining calcipotriene and betamethasone dipropionate has been approved for the treatment of plaque psoriasis in adults age 18 and older.

The Food and Drug Administration (FDA) has announced that a foam containing calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis in adults 18 years of age and older. The combination treatment, manufactured by Leo Pharmaceuticals under the brand name Enstilar, permits application across large areas of skin affected by plaque psoriasis.

The approval adds to a growing list of treatments, which can include both pharmacologic and nonpharmacologic therapy in the form of biologics, systemics, phototherapy, oral treatments that work by inhibiting specific molecules associated with inflammation, and even some alternative medicine approaches.

Topical treatments are typically first-line therapy, and while several creams and ointments are available over the counter, Enstilar is among several prescription-only medications that have shown remarkable improvement in many patients.

In a phase III clinical trial dubbed PSO-FAST, 37% of patients using Enstilar had achieved improvements in itch after three days and 84% of patients using the medication achieved improvement in itch by week 4. Similarly, patients using Enstilar experienced significant reductions in itch-related sleep loss, with 36% improving after three days and 71% experiencing improvements by week 4. More than half of patients treated with Enstilar were “clear” or “almost clear” by week 4, as assessed by the Investigator Global Assessment score of disease severity. In addition, more than half of patients who used the product achieved 75% improvement in Psoriasis Area and Severity Index score from baseline.

The medication is applied once daily to affected areas for up to 4 weeks. Patients should stop using it when control is achieved and should be instructed not to use more than 60 g every 4 days. Rapid relief from symptoms is important for psoriasis patients dealing with the often chronic, painful, and irritating condition.

In the PSO-FAST trial, adverse reactions were reported in less than 1% of patients treated with Enstilar. Those side effects can include application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.

Enstilar is not for oral, ophthalmic, or intravaginal use, and generally shouldn’t be used on the face, groin, or axillae, or if atrophy is present at the treatment site. Because the propellants in the medication are flammable, patients should also be advised to avoid fire, flame, or smoking during and immediately after using this product.