Pressemeddelelse fra LEO Pharma
BALLERUP, Denmark, JUNE 12, 2020 – LEO Pharma A/S, a global leader in medical dermatology, today presented results from the Phase 3 PSO-LONG clinical trial. PSO-LONG compared the efficacy and safety of twice-weekly Enstilar® (calcipotriene and betamethasone dipropionate)Foam, versus foam vehicle for long-term (52-week) maintenance treatment for adult patients with plaque psoriasis.(3,4) Results were presented as ePosters online at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2020.
Use of twice-weekly Enstilar (calcipotrieneand betamethasonedipropionate) Foam as a long-term maintenance treatment is investigational and is not approved in any country, and safety and efficacy are currently being evaluated by regulatory authorities.
Psoriasis is a chronic, multifactorial disease that primarily affects the skin and often requires long-term treatment.(5) Plaque psoriasis is the most common type of psoriasis characterized by an overactive immune system that causes inflammation of the skin and speeds up skin cell growth, which leads to plaque development.(1,5) Topical treatments are often prescribed in mild-to-moderate cases of plaque psoriasis.(1)
Enstilar (calcipotrieneand betamethasonedipropionate) Foam met the primary endpoint in the PSO-LONG trial by prolonging time to first relapse versus foam vehicle (56 days vs. 30 days).(3,4)
“These results, as demonstrated by the primary endpoint, introduce new clinical data for the treatment of adult patients with plaque psoriasis,” said Mark Lebwohl*, M.D., Waldman Chair of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City and Principal Investigator for the PSO-LONG trial. “This first-of-its kind year-long study and resulting data demonstrate that the fixed-dose combination of calcipotriene and betamethasone dipropionatefoam both reduced relapses and increased the number of relapse-free days versus foam vehicle.”
Safety was evaluated as effects on calcium homeostasis and on hypothalamic-pituitary-adrenal (HPA) axis with long-term use of twice-weekly calcipotriene and betamethasone dipropionatefoam, among other safety assessments. No clinically relevant effects on calcium metabolism or the HPA axis were observed. The rate of adverse events (AEs) was comparable across treatment groups.(4)
The AAD VMX 2020featured three ePosters highlighting efficacy, safety and open label data from the Phase 3 PSO-LONG trial:
In the trial:
To have participated in the trial, patients must have:
*Dr. Lebwohl is a paid consultant to LEO Pharma.
Psoriasis is a chronic, systemic inflammatory disease that primarily affects the skin in 125 million people worldwide.(1,2) About 80% of patients are affected by plaque psoriasis, the most common clinical form of psoriasis.(1) The symptoms of plaque psoriasis are itchy or painful, scaly, inflamed plaques. Plaques may appear anywhere on the body, but often appear on the scalp, knees, elbows and torso.Psoriasis is characterized as mild when less than 3% of the body is affected and moderate to severe when more than 3% of the body is affected.(6) Topical treatments are often prescribed in mild-to-moderate cases of plaque psoriasis.(1)
About Enstilar (calcipotriene and betamethasone dipropionate) Foam
Enstilar Foam is a combination of calcipotriene, a vitamin D analog, and betamethasone dipropionate, a corticosteroid.
U.S. FDA APPROVED INDICATION FOR ENSTILAR (calcipotriene and betamethasone dipropionate) Foam
Enstilar (calcipotriene and betamethasone dipropionate) Foam is indicated for the topical treatment of plaque psoriasis in patients 12 years and older. Apply Enstilar Foam to affected areas once daily for up to 4 weeks. Discontinue use when control is achieved. Instruct patients not to use more than 60 grams every 4 days.
IMPORTANT SAFETY INFORMATION
For topical use only. Enstilar Foam is not for oral, ophthalmic or intravaginal use and should not be applied on the face, groin or axillae or if skin atrophy is present at the treatment site. Do not use with occlusive dressings. Patients should wash hands after application.
WARNINGS AND PRECAUTIONS
Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios.
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise pregnant women that Enstilar Foam may increase the potential risk of having a low birth weight infant and to use Enstilar Foam on the smallest area of skin and for the shortest duration possible.
Lactation: No data are available regarding the presence of topically administered calcipotriene and betamethasone dipropionate in human milk. Use Enstilar Foam on the smallest area of skin and for the shortest duration possible while breastfeeding. Advise breastfeeding women not to apply Enstilar Foam directly to the nipple and areola to avoid direct infant exposure.
Pediatric Use: The safety and effectiveness of Enstilar Foam in pediatric patients less than 12 years of age have not been established. Pediatric patients may be more susceptible to systemic toxicity, HPA axis suppression, and adrenal insufficiency due to their larger skin surface to body mass ratios.
You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information, please see U.S. FDA Full Prescribing Information for Enstilar Foam.
(1)Menter A, Korman NJ, Elmets CA, Feldman SR, Gelfand JM, Gordon KB, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol 2009; 60: 643-659.
(2)Psoriasis Statistics. National Psoriasis Foundation website. https://www.psoriasis.org/content/statistics. Accessed April 9, 2020.
(3)Lebwohl, Mark et al. Long-term proactive management of psoriasis vulgaris with fixed-dose combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% foam; results of a Phase III randomized controlled trial. Featured at American Academy of Dermatology VMX. Poster #18223. June 12, 2020.
(4)Lebwohl, Mark et al. Safety of long-term proactive management with fixed-dose combination of calcipotriene 0.005% and betamethasone dipropionate 0.064% foam in patients with psoriasis vulgaris; results of a Phase III, multicenter, randomized, 52-week, vehicle-controlled trial. Featured at American Academy of Dermatology VMX. Poster #12797. June 12, 2020.
(5)Feldman, SR. et al. The Challenge of Managing Psoriasis: Unmet Medical Needs and Stakeholder Perspectives. Am Health Drug Benefits. 2016;9(9);504-513.
(6)Plaque Psoriasis Fact Sheet. National Psoriasis Foundation website. https://www.psoriasis.org/sites/default/files/plaque_fact_sheet.pdf. Updated October 2017. Accessed April 9, 2020.
Associate Director, Global External Communications, LEO Pharma
+1 862 337 0675
Director, Global External Communications, LEO Pharma
+45 3140 6180
Læs hele pressemeddelelsen på Via Ritzau her: https://via.ritzau.dk/pressemeddelelse/leo-pharma-presents-results-from-study-of-twice-weekly-enstilar-calcipotriene-and-betamethasone-dipropionate-foam-for-topical-use-in-long-term-maintenance-treatment-of-plaque-psoriasis?releaseId=13595107
** Ovenstående pressemeddelelse er videreformidlet af Ritzau på vegne af tredjepart. Ritzau er derfor ikke ansvarlig for indholdet **