Celgene Announces Oral OTEZLA® Receives Positive Nice Recommendation

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 benefiting 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.

–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
https://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: https://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.
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⁸ Schafer PH, et al. Apremilast, a cAMP
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⁹ Celgene data on file. UK-I&I160237 September 2016
¹⁰ Sobell J, Foley P, Toth D, et al. Effects of
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¹¹ Rich P, Gooderham M, Bachelez H,, et al.
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randomized, controlled trials (ESTEEM 1 and ESTEEM 2). J Am Acad
Dermatol. 2016;74(1):134-42. https://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
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2009;361(5):496-509
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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