The Food and Drug Administration (FDA) has approved updated labeling for Enstilar® Foam (calcipotriene and betamethasone dipropionate; Leo Pharma) to include data on long-term use in adults with plaque psoriasis.

The update was based on data from the phase 3 PSO-LONG trial, a randomized, double-blind, vehicle-controlled study that evaluated the long-term use of Enstilar Foam in 545 adults with plaque psoriasis who achieved treatment success, defined as Investigator’s Global Assessment (IGA) score of ‘clear’ or ‘almost clear’ with at least a 2-grade improvement from baseline, after an initial 4-week treatment with once-daily Enstilar Foam. 

Patients were randomized to receive either Enstilar Foam or vehicle twice-weekly on 2 non-consecutive days for up to 52 additional weeks. Patients who experienced loss of response (defined as an IGA score of at least ‘mild’) were treated once daily with Enstilar Foam for 4 weeks; those who regained an IGA score of ‘clear’ or ‘almost clear’ after 4 weeks then resumed randomized treatment.

Results showed that treatment with Enstilar Foam prolonged the time to first loss of response (primary end point) compared with vehicle (56 days vs 30 days; P <.001). As for safety, the long-term use of Enstilar Foam twice-weekly was not observed to have clinically relevant effects on calcium metabolism or the hypothalamic-pituitary-adrenal (HPA) axis. The rate of adverse events was also found to be comparable between the groups.

“The results of this novel trial suggest that long-term twice-weekly use with fixed-dose Cal/BD foam could offer to help patients maintain clear or almost clear skin for up to 52 weeks,” said Mark Lebwohl, MD, Waldman Professor, Chairman of the Kimberly and Eric J. Waldman Department of Dermatology and Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai in New York City, and principal investigator for the PSO-LONG trial.

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Enstilar Foam is indicated for the topical treatment of plaque psoriasis in patients aged 12 years and older. Each gram of Enstilar Foam contains 50mcg of calcipotriene, a vitamin D analogue, and 0.643mg of betamethasone dipropionate, a corticosteroid.

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  1. Leo Pharma announces US FDA approval for Enstilar® (calcipotriene and betamethasone dipropionate) Foam US prescribing information update to include data in long-term use in plaque psoriasis treatment. [press release]. Madison, NJ: Leo Pharma; October 22, 2020. 
  2. Enstilar Foam [package insert]. Madison, NJ: Leo Pharma; 2020.