CELGENE

Celgene announced today that adult patients in England and Wales with chronic plaque psoriasis will now have access to oral OTEZLA^® (apremilast) following a positive final appraisal determination from the National Institute for Health and Care Excellence (NICE).¹ The decision is the conclusion of a NICE Rapid Review and ensures patients in England and Wales will join those in Scotland, who have been benefitting from access to OTEZLA since it was recommended by the Scottish Medicines Consortium (SMC) in June 2015.

Psoriasis has been found to have a detrimental effect on many aspects of patients’ day-to-day lives, impacting everything from ability to dress and participate in sports to their social, work and personal relationships, with 46% of psoriasis patients saying they feel ‘depressed’ about their condition.⁴ Psoriasis is estimated to affect around 960,000 adults in the UK ^5,6 .

Professor Chris Griffiths, Professor of Dermatology, University of Manchester commented: “NICE’s decision to recommend apremilast for the treatment of psoriasis is an important step forward in the management of a disease which for many patients can have a significant detrimental effect on their lives. Apremilast offers patients a much needed new oral treatment option that does not require routine laboratory monitoring. Clinical trials of apremilast demonstrated a reduction in severity of psoriasis and associated itching as well as improvement in hard to treat areas, such as the nails and scalp. The drug has the potential to fill an important gap in the psoriasis treatment pathway and its introduction is welcomed by patients and healthcare practitioners.”

OTEZLA, a tablet, has a novel mechanism of action offering a treatment option that does not require pre-screening for tuberculosis or regular laboratory monitoring.²

NICE recognises the clinical benefit and innovation of OTEZLA by recommending it for use in England and Wales as an option for treating chronic plaque psoriasis in adults whose disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and ultraviolet-A light), or when these treatments are contraindicated or not tolerated, only if:

• the disease is severe, as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10¹

Carla Renton, Information and Communications Manager at the Psoriasis Association remarked: “This decision is welcomed by the Psoriasis Association. People with psoriasis have a chronic and complex condition that can have a profound effect on quality of life and mental wellbeing, as well as physical health. An increase in the choice of treatment options for people with psoriasis is invaluable in helping them regain control of their condition and of their day to day lives.”

Dr Dani Thomas, Medical Director, Celgene UK & Ireland commented: “Celgene has been working with NICE over the past year to ensure patients in England and Wales can benefit from OTEZLA. We are delighted that eligible people with psoriasis looking for a much needed oral treatment will now have access to OTEZLA.”

OTEZLA is an oral treatment for psoriasis, and works by reducing the activity of an enzyme called phosphodiesterase 4 (PDE4), which is involved in the process of inflammation. By reducing the activity of this enzyme, OTEZLA can help to control the inflammation associated with psoriasis, and thereby reduce the signs and symptoms of the condition.^7,8 Over 100,000 patients worldwide have already been treated with OTEZLA.⁹

In clinical trials, treatment with OTEZLA for psoriasis showed a reduction in psoriatic skin plaques and other signs and symptoms of the disease including itch, skin pain and discomfort. ^10,11 OTEZLA is also effective in the treatment of the difficult to treat aspects of scalp, nail and pruritus.^10,11

OTEZLA is currently undergoing NICE Rapid Review for active psoriatic arthritis. A positive Appraisal Consultation Document (ACD) recommending OTEZLA for use in the NHS was issued by NICE on 11^th October 2016.¹² A decision is expected later this year.

Please click here for the OTEZLA Summary of Product Characteristics.

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Notes to editors

About OTEZLA

OTEZLA is an oral inhibitor of phosphodiesterase 4 (PDE4), an enzyme specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels which is thought to indirectly modulate the production of inflammatory mediators.^8,9

OTEZLA was licensed by the European Commission in 2015 for the treatment of moderate to severe chronic plaque psoriasis in adult patients who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).²

In psoriasis, treatment with OTEZLA showed a reduction in psoriatic skin plaques and other signs and symptoms of the disease including itch, skin pain and discomfort, as well as significantly improving nail and scalp psoriasis.^9,10 Most adverse reactions were considered to be mild or moderate in severity.² Gastrointestinal (GI) symptoms including nausea and diarrhoea were the most commonly reported adverse reactions in the Phase III clinical studies. These GI adverse reactions generally occurred within the first two weeks of treatment and the majority resolved within four weeks. ^2,3

Additional important safety information based on the Summary of Product Characteristics is available here .

About Psoriasis

Psoriasis is a chronic inflammatory disease of the skin resulting from an uncontrolled immune response.^{13, 14, 15, 16} It is characterised by the overproduction of skin cells and the formation of thick, red, scaly skin plaques.^13,14,15,16 Plaque psoriasis is the most common type of psoriasis.¹⁷ About 80 percent of people who develop psoriasis have plaque psoriasis¹⁷ which appears as patches of raised, reddish skin covered by silvery-white scales.¹⁷ These patches, or plaques, frequently form on the elbows, knees, lower back, and scalp.¹⁷ Psoriasis occurs nearly equally in males and females¹⁸ and it affects many aspects of patients’ emotional and social well-being as well as daily activities.^{19, 20}

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. Celgene UK & Ireland is a subsidiary of Celgene Corporation. For more information, please visit

http://celgene.co.uk/ . Follow Celgene on Social Media: @Celgene , Pinterest , LinkedIn  and YouTube .

References

¹ NICE Final Appraisal Determination: Apremilast for moderate to severe plaque psoriasis

² OTEZLA® Summary of Product Characteristics. Current version available online at www.medicines.org.uk

³ Reich K et al. Long-term Safety and Tolerability of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, in Patients With Moderate to Severe Psoriasis: Results From a Phase III, Randomized, Controlled Trial (ESTEEM 1). P8296. Presented at the 72nd Annual Meeting of the American Academy of Dermatology 2014; March 21-25;Denver, CO, USA

⁴ Weiss SC et al. ‘Quantifying the harmful effect of psoriasis on health-related quality of life.’ Journal of American Academy of Dermatology. 2002. Oct;47(4): 512-8

⁵ Parisi R, et al. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377-85

⁶ Office for National Statistics. Annual Mid-year Population Estimates, 2013. Available from: http://www.ons.gov.uk/ons/dcp171778_367167.pdf . Last accessed May 2015National Institute for Health and Care Excellence. Psoriasis: The assessment and management of psoriasis. NICE guidelines [CG153] Published date: October 2012

⁷ Schafer P. Apremilast mechanism of action and application to psoriasis and psoriatic arthritis. Biochem Pharmacol . 2012;83:1583–1590.

⁸ Schafer PH, et al . Apremilast, a cAMP phosphodiesterase-4 inhibitor, demonstrates anti-inflammatory activity in vitro and in a model of psoriasis. Br J Pharmacol . 2010;159:842–855

⁹ Celgene data on file. UK-I&I160237 September 2016

¹⁰ Sobell J, Foley P, Toth D, et al . Effects of Apremilast on Pruritus and Skin Discomfort/Pain Correlate with Improvements in Quality of Life in Patients with Moderate to Severe Plaque Psoriasis. Acta Derm Venereol. 2016;

¹¹ Rich P, Gooderham M, Bachelez H,, et al . Apremilast, an oral phospodiesterase 4 inhibitor, in patients with difficult-to-treat nail and scalp psoriasis; Results of Phase III randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad Dermatol. 2016;74(1):134-42. http://www.ncbi.nlm.nih.gov/pubmed/26549249

¹² NICE Appraisal Consultation Document: Apremilast for active psoriatic arthritis

¹³ Racz E, et al . GATA3 expression is decreased in psoriasis and during epidermal regeneration; induction by narrow-band UVB and IL-4. PLoS One . 2011;6:e19806

¹⁴ Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med . 2009;361(5):496-509

¹⁵ Reich K. The concept of psoriasis as a systemic inflammation: implications for disease management. JEADV. 2012;26(2): 3–11

¹⁶ Nickoloff BJ and Nestle FO. Recent insights into the immunopathogenesis of psoriasis provide new therapeutic opportunities. J Clin Invest . 2004;113(12):1664-1675

¹⁷ Villasenor-Park J, Wheeler D, Grandinetti L. Psoriasis: Evolving treatment for a complex disease. CCJM . 2012;79(6)

¹⁸ Psoriasis Association. About Psoriasis. Available from: https://www.psoriasis association.org.uk/pages/view/about-psoriasis. Last accessed June 2016

¹⁹ Kurd SK, et al . The risk of depression, anxiety and suicidality in patients with psoriasis: A population-based cohort study. Arch Dermatol . 2010;146(8):891-895

²⁰ Hrehorów E, et al . Patients with psoriasis feel stigmatized. Acta Derm Venereol . 2012;92(1):67-72 2

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Celgene UK & Ireland
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Amanda Simonds
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asimonds@celgene.com
or
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