Oral OTEZLA Receives Positive NICE Recommendation for Adults With Chronic Plaque Psoriasis

Celgene recently announced 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). 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. Psoriasis is estimated to affect around 960,000 adults in the UK.

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. NICE recognizes 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 10.

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. Over 100,000 patients worldwide have already been treated with OTEZLA.

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. OTEZLA is also effective in the treatment of the difficult to treat aspects of scalp, nail and pruritus.

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 October 11, 2016. A decision is expected later this year.

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.

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. 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.

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

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