BALLERUP, Denmark, June 10, 2015 /PRNewswire/ --
LEO Pharma A/S today announced that new data being presented at the 23rd World Congress of Dermatology shows aerosol foam Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g), the Company's dual-action investigational aerosol foam for the treatment of psoriasis vulgaris, provided rapid itch relief and improvements in itch-related sleep loss for patients suffering from psoriasis. The data is from PSO-FAST (Psoriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trail), a Phase 3 clinical trial.
Between 70 percent and 90 percent of people with psoriasis suffer from itch, which can cause patients to experience additional stress or embarrassment. Additionally, psoriasis patients suffering from itch experience sweating, feel a sensation of heat or pain in the affected area and have difficulty falling asleep or are often awakened as a result of itching.
"These data are encouraging for the vast majority of psoriasis patients that are also suffering from itch related to their disease," said Dr. Craig Leonardi, a Clinical Professor of Dermatology at St. Louis University School of Medicine (United States) and the lead investigator of the PSO-FAST clinical trial. "Itch can have a significant impact on the overall quality of life for psoriasis patients and having a well-tolerated and effective treatment option to rapidly relieve itch is important."
The PSO-FAST clinical trial is a large, Phase 3, double-blind trial that included 426 psoriasis patients in the United States. Patients in the trial were split into two groups with 323 patients receiving Enstilar® and 103 patients receiving placebo in the form of the aerosol foam vehicle alone. Results from the study found that 37% of patients using Enstilar® had achieved improvements in itch after three days and 84% of patients using Enstilar® achieved improvement in itch by week 4. Similarly, patients using Enstilar® experienced improvements in itch-related sleep loss, with 36% improving after three days and 71% experiencing improvements by week 4.
Additional data from the PSO-FAST clinical trial showed that 81% of patients receiving Enstilar® experienced clinically meaningful improvements in health-related quality of life (HRQoL). The HRQoL of patients was assessed using the Dermatology Life-Quality Index (DLQI) and the generic five-dimension EQ5D questionnaire. Patient feedback on HRQoL was assessed with DLQI at baseline and weeks 1, 2 and 4 and EQ5D was assessed at baseline and week 4.
"We are pleased with the results of the PSO-FAST trial and believe these data further highlight the value Enstilar® may provide to patients living with psoriasis," said Kim Kjøller, Senior Vice President, Global Development at LEO Pharma. "Improving the lives of patients living with skin diseases is our number one priority and we look forward to continuing to work with regulatory authorities to obtain approval and make Enstilar® available to patients worldwide."
In December, LEO Pharma submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Enstilar® and Marketing Authorization Applications were submitted to 30 Regulatory Agencies in Europe in March 2015. Additional information about the PSO-FAST clinical trial is available at https://clinicaltrials.gov/ct2/show/NCT01866163.
Psoriasis is a chronic, inflammatory skin disease, which is frequently accompanied by multiple physical and/or psychological comorbidities, such as metabolic syndrome and psoriatic arthritis.
Psoriasis is estimated to affect about 2-4% of the population in western countries.80% of patients are affected by psoriasis vulgaris - the most common type of psoriasis.
Topical treatments are first-line therapies for the majority of patients suffering from psoriasis.
About LEO Pharma A/S
Founded in 1908, LEO Pharma A/S is an independent, research-based pharmaceutical company. LEO Pharma develops, manufactures and markets pharmaceutical drugs to dermatologic and thrombotic patients in more than 100 countries globally. The company has its own sales forces in 61 countries and employs around 4,800 people worldwide. LEO Pharma A/S is headquartered in Denmark and is wholly owned by the LEO Foundation.
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- Life with psoriasis: Understanding the itch. National Psoriasis Foundation. Accessed on April 15, 2015. http://www.psoriasis.org/life-with-psoriasis/understanding-the-itch.
- Yosipovitch G, et al. The prevalence and clinical characteristics of pruritus among patients with extensive psoriasis. British Journal of Dermatology, 2000. 143: 969-973.
- Leonardi C, et al. Fixed-combination calcipotriene 0.005%/betamethasone dipropionate 0.064% aerosol foam provides rapid itch relief and improvements in itch-related sleep loss in psoriasis patients (PSO-FAST study). 23rd World Congress of Dermatology Meeting, Vancouver, Canada, 8-13 June 2015.
- Leonardi C, et al. Innovative fixed-combination calcipotriene 0.005%/betamethasone dipropionate 0.064% aerosol foam provides clinically relevant improvement in quality of life in psoriasis patients (PSO-FAST study). 23rd World Congress of Dermatology Meeting, Vancouver, Canada, 8-13 June 2015.
- Taraska V, et al. Fixed combination aerosol foam calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) exhibits no impact on the HPA axis and calcium homeostasis in patients with extensive psoriasis vulgaris: a multicenter, single-arm, Phase II, 4-week MUSE study. Presented at the Skin Disease Education Foundation's 15th Annual Las Vegas Dermatology Seminar & the 11th Annual SDEF Psoriasis Forum, October 30-November 1, 2014.
- Parisi R, et al. Global Epidemiology of Psoriasis: A Systematic Review of Incidence and Prevalence. The Society for Investigative Dermatology. J Invest Dermatol 2013;133(2):377-85.
- Reich K, et al. Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicentre, randomized, controlled, prospective study. Journal of European Academy of Dermatology Venereology 2014: October (epub ahead of print) DOI: 10.1111/jdv.12774.
SOURCE LEO Pharma A/S