First-in-class oral treatment for psoriatic
arthritis made available via the National Health Service
(NHS)
Celgene announced today that the National Institute for Health
and Care Excellence (NICE) has issued a final appraisal
determination (FAD) recommending the use of OTEZLA (apremilast) for
the treatment of adult patients with active psoriatic arthritis who
have had an inadequate response to or have been unable to tolerate
Disease Modifying Anti-Rheumatic Drugs (DMARDs).1 OTEZLA does not
require pre-screening for tuberculosis or regular laboratory
monitoring.2
“Psoriatic arthritis is a chronic disease that causes
significant strain on NHS resources,” said Dr Helena
Marzo-Ortega, Honorary Senior Lecturer and Consultant at Leeds
Teaching Hospitals NHS Trust. “Addressing the symptoms of both
psoriasis and psoriatic arthritis, the availability of OTEZLA on
the NHS marks a major milestone in the management of psoriatic
arthritis.”
Psoriatic arthritis is a complex disease which involves multiple
manifestations that can impact skin and joints and is most common
in people aged 30 years to 50 years.3 It is estimated that over
296,000 people in the UK are affected by this incapacitating
disease.4,5 Living with psoriatic arthritis can hinder a person’s
ability to carry out simple everyday activities; from getting in or
out of bed, to walking outdoors on flat ground.6
Following initial negative guidance issued by NICE in September
2015, OTEZLA was reappraised under the NICE Rapid Review process.1
OTEZLA, alone or in combination with DMARDs, is now recommended
with a Patient Access Scheme for adults with active psoriatic
arthritis when:
- they have peripheral arthritis with 3
or more tender joints and 3 or more swollen joints and
- their disease has not responded to
adequate trials of at least 2 standard DMARDs, given either alone
or in combination1
Today’s decision brings access for patients in England and Wales
in line with those in Scotland, where OTEZLA was recommended by the
Scottish Medicines Consortium (SMC) in June 2015.7
Dr Dani Thomas, Medical Director, Celgene UK & Ireland,
commented: “We are delighted that patients in England and Wales
can now access OTEZLA via the NHS, bringing availability in line
with patients in Scotland. OTEZLA’s novel mechanism of action and
oral administration provides psoriatic arthritis patients with a
much needed treatment option. Celgene will continue our dedication
to develop and deliver innovative medicines for people affected by
diseases where there is a high unmet need.”
OTEZLA is an oral treatment for psoriatic arthritis that works
by reducing the activity of an enzyme called phosphodiesterase 4
(PDE4), which is involved in the process of inflammation.8 By
reducing the activity of this enzyme, OTEZLA can help to control
the inflammation associated with psoriatic arthritis, and thereby
reduce the signs and symptoms of the condition.9, 10
The Psoriatic Arthritis Long-term
Assessment of Clinical Efficacy (PALACE)
programme is one of the largest global clinical development
programmes ever conducted in psoriatic arthritis and it measured
the efficacy and safety of OTEZLA.11 Across PALACE 1, 2 and 3,
significantly more patients on OTEZLA achieved ACR20 at Week 16
than those on placebo.8
OTEZLA has demonstrated proven and durable efficacy in psoriatic
arthritis, with improvement in swollen and tender joints, as well
as pre-existing dactylitis (inflammation of fingers and toes,
commonly known as “sausage fingers and toes”) and enthesitis
(inflammation at sites where tendons or ligaments insert into bone)
with a statistically significant improvement in physical function.8
The most common adverse reactions in Phase III clinical studies
were diarrhoea and nausea. These adverse reactions generally
occurred within the first two weeks of treatment and usually
resolved within four weeks.2
– Ends –
NOTES TO EDITORS
About OTEZLA®
OTEZLA® is an oral inhibitor of phosphodiesterase 4 (PDE4)
specific for cyclic adenosine monophosphate (cAMP).8 PDE4
inhibition results in increased intracellular cAMP levels which is
thought to indirectly modulate the production of inflammatory
mediators.9,10
OTEZLA, alone or in combination with Disease Modifying
Anti-Rheumatic Drugs (DMARDs), was approved by the European
Medicines Agency in 2015 for the treatment of psoriatic arthritis
in adult patients who have had an inadequate response or who have
been intolerant to a prior DMARD therapy.
OTEZLA was also licensed by the European Commission for the
treatment of moderate to severe chronic plaque psoriasis in adult
patients who do not respond to, have a contraindication to, or are
intolerant to other systemic therapy including cyclosporine,
methotrexate or psoralen and ultraviolet-A light (PUVA).8
OTEZLA has a novel mechanism of action, offering a treatment
option that does not require pre-screening for tuberculosis or
regular laboratory tests.2 In clinical trials of psoriatic
arthritis, treatment with OTEZLA demonstrated a statistically
significant improvement in physical function vs. placebo as well as
improving disease-related quality of life.12
The Summary of Product Characteristics is available here.
About Psoriatic Arthritis
Psoriatic arthritis is a painful, chronic inflammatory disease
characterised by pain, stiffness, swelling and tenderness of the
joints, inflammation of specific ligaments and tendons, and
decrease in physical functioning.13 Psoriatic arthritis can impact
the ability to perform day-to-day activities and has been reported
to increase work disability.14,15 Enthesitis (inflammation at sites
where tendons or ligaments insert into bone) and dactylitis
(inflammation of fingers and toes, commonly known as “sausage
digits”) are specific disease manifestations related to psoriatic
arthritis.13 Up to 30% of people with psoriasis may also experience
psoriatic arthritis.16
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: Apremilast for the treatment of active psoriatic
arthritis
2 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
3 The Cleveland Clinic Foundation. Disease Management chapter on
Psoriatic Arthritis by M. Elaine Husni. Available at:
http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/rheumatology/psoriatic-arthritis/
Last accessed December 2016
4 Population estimates for UK, England and Wales, Scotland and
Northern Ireland. Available at:
https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationestimates/datasets/populationestimatesforukenglandandwalesscotlandandnorthernireland
Last accessed December 2016.
5 NICE: Costing statement: Implementing the NICE guidance on
ustekinumab for treating active psoriatic arthritis (rapid review
of technology appraisal guidance 313) (TA340). Published: May
2015
6 Lebwohl et al.Patient perspectives in the management of
psoriasis: Results from the population-based Multinational
Assessment of Psoriasis and Psoriatic Arthritis Survey. J Am Acad
Dermatol. 2014 0190-9622
7 OTEZLA® Detailed Advice Document (DAD)
https://www.scottishmedicines.org.uk/files/advice/apremilast__Otezla__plaque_psoriasis_FINAL_May_2015_REVI
SED_010615_for_website.pdf Last accessed December 2016
8 OTEZLA® Summary of Product Characteristics. Current version
available online at www.medicines.org.uk Last accessed December
2016
9 Schafer P. Apremilast mechanism of action and application to
psoriasis and psoriatic arthritis. Biochem Pharmacol.
2012;83:1583–1590
10 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
11 OTEZLA Clinical development program. Available at:
https://www.otezla.net/psoriatic-arthritis/clinical-efficacy/study-design/
Last accessed December 2016
12 Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of
psoriatic arthritis in a phase 3 randomised, placebo-controlled
trial with apremilast, an oral phosphodiesterase 4 inhibitor. Ann
Rheum Dis. 2014;73:1020–1026
13 Gottlieb A, et al. Guidelines of care for the management of
psoriasis and psoriatic arthritis: Section 2. Psoriatic arthritis:
overview and guidelines of care for treatment with an emphasis on
the biologics. J Am Acad Dermatol. 2008;58:851 864
14 Lee S, Mendelsohn A, Sarnes E. The burden of psoriatic
arthritis: A literature review from a global health systems
perspective. P&T. 2010;35(12):680-689
15 Tillett W, de-Vries C, McHugh NJ. Work disability in
psoriatic arthritis: a systematic review. Rheumatology.
2012;51:275-283
16 National Institute for Health and Care Excellence.
Etanercept, infliximab and adalimumab for the treatment of
psoriatic arthritis: Technology appraisal guidance 199. August
2010
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Celgene UK & IrelandMedia:Amanda SimondsSenior
Corporate Affairs and Patient Advocacy ManagerT. 020 8831
8672asimonds@celgene.comorCelgeneInvestors:Patrick E.
Flanigan IIICorporate Vice President, Investor RelationsT. +1 908
673 9969pflanigan@celgene.com
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