Approved by NICE for patients with severe
plaque psoriasis as defined by PASI and DLQI greater than or equal
to 10
Novel oral treatment that does not require
regular laboratory monitoring
Recognised by NICE as an oral alternative to
existing injectable biological therapies
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
11th October 2016.12 A decision is expected later this year.
Please click here for the OTEZLA Summary of Product
Characteristics.
--ENDS--
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 psoriasis17which 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.17Psoriasis 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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version on businesswire.com: http://www.businesswire.com/news/home/20161020005561/en/
Celgene UK & IrelandMedia:Amanda SimondsSenior
Corporate Affairs and Patient Advocacy ManagerT. 020 8831
8672asimonds@celgene.comorCelgeneInvestors:Patrick E.
Flanigan IIICorporate Vice PresidentT. +1 908 673
9969pflanigan@celgene.com
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