Title: Certolizumab pegol for treating chronic plaque psoriasis [ID1232]
Funder: Department of Health and Social Care

Abstract: To appraise the clinical and cost effectiveness of certolizumab pegol within its marketing authorisation for treating moderate to severe plaque psoriasis.

Lay abstract: Plaque psoriasis is an inflammatory skin condition characterised by an accelerated rate of turnover of the upper layer of the skin (epidermis). This leads to an accumulation of skin cells forming raised plaques on the skin. These plaques can be flaky, scaly, itchy and red or a darker colour to the surrounding skin. Plaque psoriasis may affect the scalp, elbows, knees and lower back and sometimes the face, groin, armpits or behind the knees. Although it is a chronic, persistent, severe condition, its course may be unpredictable, with flare-ups and remissions. Psoriasis is generally graded as mild, moderate or severe and takes into account the location, surface area of skin affected and the impact of the psoriasis on the person. The Psoriasis Area and Severity Index (PASI) is an index of disease severity in adults and takes into account the size of the area covered with psoriasis as well as redness, thickness and scaling. In addition, the Dermatology Life Quality Index (DLQI) is a validated tool that can be used to assess the impact of psoriasis on physical, psychological and social wellbeing. The prevalence of psoriasis in the United Kingdom is estimated to be between 1.3% and 2.2% (1). About 90% of people with the condition have plaque psoriasis and about 20% have moderate to severe disease (15% moderate, 5% severe),(2) equating to approximately 102,000 to 172,000 adults in England.(3) There is no cure for psoriasis but there is a wide range of topical and systemic treatments that can manage the condition. Most treatments reduce the severity of psoriasis flares rather than prevent episodes. Psoriasis has to be treated continually and on a long-term basis. NICE clinical guideline 153 on psoriasis recommends that people with psoriasis should be offered topical therapies such as corticosteroids, vitamin D and vitamin D analogues. For people in whom topical therapy does not alleviate symptoms the guideline recommends phototherapy (broad- or narrow-band ultraviolet B light) and psoralen with ultraviolet A phototherapy (PUVA). The guideline recommends systemic non-biological therapies for people whose psoriasis: • cannot be controlled with topical therapy and • has a significant impact on physical, psychological or social wellbeing, and • one or more of the following apply: o psoriasis is extensive or o psoriasis is localised and associated with significant functional impairment and/or high levels of distress or o phototherapy has been ineffective, cannot be used or has resulted in rapid relapse. NICE technology appraisal guidance 103, 146, 180, 350, 419, 442, 475, 511 and 521 recommend etanercept, adalimumab, ustekinumab, secukinumab, apremilast, ixekizumab, dimethyl fumarate, brodalumab and guselkumab, respectively, as treatment options for adults with severe psoriasis (as defined by a total PASI score of 10 or more and a DLQI score of more than 10) whose disease has not responded to, or who are intolerant to or contraindicated to standard systemic therapies such as ciclosporin, methotrexate and PUVA. Technology appraisal guidance 134 recommends infliximab as a treatment option for adults with very severe psoriasis (as defined by a total PASI score of 20 or more and a DLQI score of more than 18) whose disease has not responded to, or who are intolerant to or contraindicated to standard systemic therapies. Biosimilar products of the biological therapies are available for use the NHS. References 1. NICE (2017) Psoriasis: assessment and management Clinical guideline 153. 2. Menter A, Korman NJ, Elmets CA et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol 2011; 65:137–74. 3. Office for National Statistics (2017) Population Estimates for UK, England and Wales, Scotland and Northern Ireland mid-2016. Accessed June 2018.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: SKIN