Celgene Release: Oral OTEZLA (Apremilast) Receives Positive Nice Recommendation For Adults With Psoriatic Arthritis

STOCKLEY PARK, England--(BUSINESS WIRE)--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

“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 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

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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 72^nd 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