New drug for plaque-type psoriasis! Leo Pharmaceuticals Enstilar foam agent long-term treatment has significant efficacy and good safety!

Oct 26, 2020 // -- LEO Pharma recently announced that the U.S. Food and Drug Administration (FDA) has approved enstilar (calcistol/dipropanate) U.S. Prescription Information (USPI) update to include data from the PSO-LONG clinical trial, which evaluated the treatment of adult plaque psoriasis 2 times a week for long-term use (52 weeks).
Enstilar, a compound of calcium-d-likes and methamphetamine, a corticosteroid, has been approved in the United States for local treatment of plaque-type psoriasis in patients ≥12 years of age.
Enstilar is the first spray foam psoriasis drug, a foam-free, non-alcoholic preparation that is used once a day on most skin throughout the body for easy access and use.
psoriasis is a chronic multi-factor disease that mainly affects the skin.
125 million people worldwide, plaque-type psoriasis is the most common type of psoriasis, affecting more than 80% of patients.
plaque-type psoriasis is characterized by an overactive immune system, which causes skin inflammation and accelerates the growth of skin cells, leading to plaque formation, and local treatment is usually used in mild to moderate plaque-type psoriasis.
U.S. Supplemental New Drug Application (SNDA) is based on data from PSO-LONG Phase 3 clinical trials.
This is a randomized, double-blind, perfusion-controlled trial (NCT02899962) that assesses the efficacy and safety of long-term use of Enstillar foam in adult patients with a daily use of Enstilar foam agents for the first four weeks (defined as an overall physician assessment of the PGA as "skin loss removal" or "near total removal" and at least 2 levels higher than the baseline).
study, patients (n-545) were randomly assigned to receive Enstilar foam or perfusion foam twice a week (non-continuous use for 2 days) and treated for up to 52 weeks.
If the patient experiences loss of response (defined as a PGA score of at least "mild"), patients who are treated with Enstillar foam once a day for 4 weeks and the PGA score of "skin loss removal" or "almost complete removal" are restored after 4 weeks to resume random long-term treatment.
results showed that patients treated with Enstilar foam twice a week for long periods of time had a later first reaction loss and a shorter duration of loss of reaction than patients who were treated with the endostilar foam.
in the PSO-LONG trial, the Enstilar foam reached its main end point: the first reaction loss (56 days vs 30 days, p<0.001) was delayed compared to the endoentic foam.
safety evaluation as: the effects of long-term use of Enstilar foam on calcium stability and hypothyroidism-adrenal axis (HPA), as well as other safety assessments.
clinically related effects of calcium metabolism or HPA axis were not observed.
adverse event rate (AE) was comparable between treatment groups.
Mark Lebwohl, lead investigator on the PSO-LONG trial and director of clinical therapy at Icahn School of Medicine at Mount Sinai in New York City, said: "Data on the long-term treatment of psoriasis with external drugs is very important.
, this is the first and only study to report long-term results from Enstilar - the efficacy and safety of treatment up to 52 weeks (twice a week) after the first four weeks of the dosing period.
the results of this new trial show that long-term use, 2 times a week Enstilar foam therapy can help patients keep skin damage removed or almost completely removed for up to 52 weeks.
":) Original origin: LEO Pharma Announces U.S. FDA approval for ® (calcipotriene and betamethasone dipropionate) Foam U.S. Prescribing Information Update to Include Data In Long-term Use in Plaque Psoris Treatment