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Published on 20 June 2016

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LEO Pharma launches Enstilar®, the first fixed-combination foam spray for the treatment of plaque psoriasis

Today sees the launch of Enstilar® the first fixed-combination, cutaneous foam spray for the once-daily topical treatment of all extents of plaque psoriasis for patients who are 18 years or older in the UK.1

Today sees the launch of Enstilar® the first fixed-combination, cutaneous foam spray for the once-daily topical treatment of all extents of plaque psoriasis for patients who are 18 years or older in the UK.1

Data shows that Enstilar® is a more effective topical combination treatment than those currently available, is generally well-tolerated,2,3 with more than half of patients in clinical trials experiencing significant visible signs of improvement within four weeks and with some patients seeing improvements at one week.4

 

This innovative treatment can also improve patients’ quality of life (QoL).5 75% of patients feel that their quality of life is significantly impacted by psoriasis, both emotionally and physically.5 81% of psoriasis patients using Enstilar® foam spray in trials reported QoL improvements after four weeks,6 with more than 70% seeing a reduction in itch-related sleep loss.4 The symptomatic relief experienced by the majority of patients may be attributed to the cooling effect of the new foam spray.7

Enstilar® foam spray represents a welcome new choice of topical therapy for people with plaque psoriasis, particularly those who wish to explore new options with their GP and/or whose next step would be a referral to consider transitioning to systemic therapy“, comments Professor Chris Griffiths, Foundation Professor of Dermatology, The University of Manchester, “Clinical data point to the superior efficacy of Enstilar® over other topical combination therapies and to a favourable safety profile.

We are delighted that there is a new, effective treatment choice now available to treat plaque psoriasis, an area of significant unmet need” comments John Warne, Founder, Psoriasis Help Organisation, “Over 1.5 million people across the UK are living each day with the significant challenges of this chronic skin condition so we welcome new options to help them take back control.

Adherence is a significant challenge for patients living with psoriasis (studies consistently suggest that up to 40% of people with psoriasis do not use their medication as directed).8 In recognition of this challenge and to help patients achieve optimal outcomes, LEO Pharma has developed the below suite of new resources:

  • QualityCareTM website – For more information about psoriasis visit www.qualitycarebyleo.co.uk
  • MyPso app – For practical advice to make small changes that can have a big impact on psoriasis, download the MyPso app at the Apple App Store or Google Play
  • Nurse support line – To speak in confidence to a nurse before, during and after treatment call our dedicated nurse support line on 0800 090 2165 for the UK. Lines are open Monday to Friday from 08:30-17:00

 

The launch of Enstilar® foam spray in the UK follows findings in the positive regulatory review of the results of the pivotal Phase IIIa PSO-FAST study,4 which evaluated its efficacy and safety profile across a four week period, and the Phase II MUSE safety profile study.3 In the PSO-FAST clinical trial, over half of patients treated with calcipotriol/betamethasone dipropionate foam spray were “Clear” or “Almost Clear” by week four, as measured by the Physician Global Assessment (PGA) improvement score.4 Additionally, more than half of patients treated with calcipotriol/betamethasone dipropionate foam spray achieved a 75% improvement in modified (excluding head) Psoriasis Area and Severity Index (mPASI) score from baseline after four weeks of treatment.4

The launch of Enstilar® is an exciting landmark for LEO Pharma, which is committed to improving outcomes and quality of life for people living with skin conditions such as psoriasis,” comments  Geraldine Murphy, Managing Director of LEO Pharma UK & Ireland. “This is the first combination treatment of its kind and the foam spray delivery offers a convenient new treatment option. Insights from patients show that it will be easy and convenient to use, as well as being effective and generally well-tolerated. This could be a great advantage in improving treatment adherence, which can be such a challenge for people living with long-term skin conditions.

The unique delivery system of calcipotriol/betamethasone dipropionate foam spray provides a convenient treatment option for psoriasis patients,2 ensuring the product is easy-to-apply.2 It was developed to treat patients with plaque psoriasis1 – the most common clinical form of psoriasis, affecting approximately 80% of psoriasis patients.9

References

  1. Enstilar® SmPC; UK. Available at: www.medicines.org.uk. Last Accessed June 2016.
  2. Koo J et al. Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris – A randomized phase II study. Journal of Dermatological Treatment 2015; 1471–1753.
  3. Taraska V et al. A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris. Journal of Cutaneous Medicine and Surgery 2015; 1–8.
  4. 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): 1468–77.
  5. Leonardi C et al. Improvements in health-related quality of life, and correlations with efficacy measures, with fixed combination calcipotriol plus betamethasone dipropionate aerosol foam (psoriasis PSO-FAST study. Poster 1722 presented at the 24th EADV Congress; Copenhagen, Denmark, 7–11 October 2015.
  6. Bhosle MJ et al. Quality of life in patients with psoriasis. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC1501000/#B9. Last accessed: June 2016.
  7. LEO Pharma data on file: LEO90100 – 004 April 2016.
  8. Richards HL. Adherence to treatment in patients with psoriasis, Journal of the European Academy of Dermatol and Venereology, 2006;20(4):370–9.
  9. American Academy of Dermatology. Psoriasis. Available at: www.aad.org/media/stats/conditions/psoriasis. Last accessed June 2016.


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