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New data presented at EADV show skin clearance with Enstilar® improves quality of lifefootnotes 1 and 21,2

Direct correlation between improved skin clearance and increased QoL for psoriasis patientsfootnote 22

Ballerup, Denmark, Wednesday 28 September 2016: New data, announced at the European Academy of Dermatology and Venereology (EADV) congress today, show that improved skin clearance with Enstilar® cutaneous foam (calcipotriol/betamethasone dipropionate 50 micrograms/g / 0,5 mg/g; Cal/BDP foam) leads to increased quality of life (QoL) in adult patients with psoriasis vulgaris.footnote 22

The data presented at the EADV congress come from a post-hoc analysis of the Phase III, 12-week study, PSO-ABLE, which examined the efficacy of Cal/BDP spray foam versus Cal/BDP gel3. In the post-hoc analysis, patients’ Dermatology Life Quality Index (DLQI) score was assessed against a measure of skin clearance – excluding the head, which was not treated – demonstrated by a reduction in modified Psoriasis Area and Severity Index (mPASI) of 50–<75%, 75–<90% or 90% at week 4.footnote 22

The most common clinical form of psoriasis, psoriasis vulgaris is estimated to affect 3.7 million Europeans, with men and women equally likely to be affectedfootnotes 4 and 54,5. It is a chronic, debilitating disease, and patients with inadequately managed psoriasis can experience substantial burden of illness, with similar reductions in quality of life to those experienced by patients with diabetes or cancerfootnote 66. As a result of the condition, one in three patients have experienced depression and/or anxiety and one in 10 have contemplated suicide.footnotes 7, 8 and 97,8,9

“The study analysis finally provides good evidence for a correlation between improved skin clearance and increased quality of life in psoriasis. These data show that the benefits of treatment with Enstilar® extended beyond the solely physical,” said Professor Chris Griffiths, study lead. “It’s reassuring to see that participants whose visible signs of psoriasis were addressed also experienced  an improvement in overall wellbeing; this should be acknowledged by healthcare professionals managing people with psoriasis in that the psychological as well as the physical impact of the disease should be addressed.footnote 22

The number of participants with a DLQI score of 0/1 – which indicates the condition has no impact on QoL – generally increased with greater improvements in skin clearance amongst those both in the Cal/BDP foam treatment group and the Cal/BDP gel treatment group.footnote 22

“We are pleased to announce the results of this analysis, which provide further evidence of the difference that Enstilar® can make to the lives of people with psoriasis,” said Gitte Aabo, President and CEO of LEO Pharma. “The emotional impact of psoriasis can be just as profound, with more than ¾ of people saying psoriasis affects their quality of life. This data emphasises just how important getting the right treatment and formulation is to improve both physical and mental wellbeing, and how Enstilar® aims to help achieve that.”

About the studyfootnotes 1 and 31,3

PSO-ABLE was an investigator-blinded study in which patients aged ≥18 years were randomized 4:4:1:1 to once-daily Cal/BDP foam (n=185), Cal/BDP gel (n=188), foam vehicle (n=47) or gel vehicle (n=43). As a measure of skin clearance, the proportion of patients achieving a reduction in modified Psoriasis Area and Severity Index (excluding the head, which was not treated; mPASI) of 50–<75%, 75–<90% or 90% was assessed at week 4. QoL was measured using the Dermatology Life Quality Index (DLQI; range, 0–30), where a score of 0 or 1 indicates no impact on the patient’s life.

About Enstilar

Enstilar® (calcipotriol/betamethasone dipropionate 50 micrograms/g + 0.5 mg/g cutaneous foam) is a four week topical combination psoriasis vulgaris treatment in a foam spray formulationfootnote 11, that has been shown to deliver results at week four, with visible signs of improvement at week one.footnotes 10, 11 and 1210,11,12 The once-daily treatment is suitable for adults with all severities of psoriasis vulgaris.footnote 11

In March 2016, LEO Pharma received scientific approval of Enstilar® for the treatment of psoriasis vulgaris in patients 18 years of age or older in the EU. The scientific approval means that LEO Pharma received a positive outcome of the decentralized procedure. Enstilar® has also been approved by the FDA and is available for use in the U.S. as a treatment for psoriasis vulgaris in patients 18 years of age or older.

About psoriasis

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.footnote 66 Psoriasis is estimated to affect about 2-4% of the population in western countries.footnote 44 80% of patients are affected by psoriasis vulgaris – the most common type of psoriasis.footnote 1313 Topical treatments are first-line therapies for the majority of patients suffering from psoriasis.footnotes 1313

About LEO Pharma A/S

LEO Pharma helps people achieve health skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 4,800 people worldwide.

References

  1. Enstilar® SmPC. Available at: https://www.medicines.org.uk/emc/medicine/31833
  2. Griffiths C, et al. Association of skin clearance with improved QoL in patients with psoriasis treated with calcipotriol plus betamethasone dipropionate aerosol foam. European Academy of Dermatology and Venereology ePoster ahead of print (to be inserted)
  3. Paul, C, et al. Calcipotriol plus betamethasone dipropionate aerosol foam provides superior efficacy vs. gel in patients with psoriasis vulgaris: randomized, controlled PSO-ABLE study. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.13859
  4. 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
  5. EFPIA. Who does psoriasis effect? Available at: http://www.efpia.eu/diseases/134/59/psoriasis (last accessed 2 September 2016)
  6. 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
  7. Dubertret L, Mrowietz U, Ranki A, et al. EUROPSO Patient Survey Group. European patient perspectives on the impact of psoriasis: the EUROPSO patient membership survey. Br J Dermatol 2006;155(4):729–36
  8. Kurd SK, Troxel AB, Crits-Christoph P, Gelfand JM. The risk of depression, anxiety, and suicidality in patients with psoriasis: a population-based cohort study. Arch Dermatol 2010;146(8):891–5
  9. Eedy D, Burge S, Potter J, et al, on behalf of The British Association Dermatologists and Clinical Effectiveness and Evaluation Unit, Royal College of Physicians Clinical Standards Department. An audit of the provision of dermatology services in secondary care in the United Kingdom with a focus on the care of people with psoriasis. January 2008
  10. Leonardi C, et al. Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris – a Randomized Phase III Study (PSO-FAST). Journal of Drugs in Dermatology 2015; 14:12
  11. LEO Pharma data on file: LEO90100 – 004 April 2016
  12. LEO Pharma data on file: LEO90100 – 003 March 2016
  13. Reich K, et al. Efficacy of a fixed combination of with 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