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Psoriasis Stratification to Optimise Relevant Therapy

Research Summary:

This study uses psoriasis stratification in order to optimise relevant therapy.  Psoriasis is a chronic inflammatory skin disease that affects 2% of the population. It is characterized by the presence of raised, scaly, red skin plaques. Psoriasis patients suffer from a high degree of morbidity and a decreased quality of life, due to the unpleasant skin lesions and the side effects associated with the therapy. In addition to the skin symptoms, there are important systemic manifestations associated with psoriasis including metabolic syndrome, depression, cancer and the risk of cardiovascular disease (Nestle et al. 2009).

There is no definitive cure for the disease, but the introduction of new biologic drugs for disease treatment has improved patients’ quality of life. However biologic therapy is expensive and up to 30% of patients do not respond adequately. In the USA it is estimated that by 2020 the psoriasis market for biologics will grow to $5.5 billion from $2.6 billion in 2010. In the UK, the introduction into standard clinical practice of NICE approved biologic therapies, targeting TNFa andIL12/ 23 pathways, has had a dramatic beneficial effect on clinical outcomes for patients with severe psoriasis. However patient p.a. costs for biologic therapy at ~£10k is not offset by an 80% reduction in inpatient episodes. This may be explained by the fact that it is unknown which biologic is best suited to an individual patient. For example, 90% efficacy rates at 1216 weeks are 11%, 37% and 45% for etanercept, adalimumab and ustekinumab respectively and each of these drugs may lose effect over time (approximately 15% attrition p.a.). Furthermore, new small molecules, such as apremilast, and biologics including biosimilars and IL17inhibitors, are currently in development with a potential wide range in efficacy and cost.

Inclusion Criteria:

Patients who have given written informed consent

Patients 18 years old and over
Adult patients with chronic plaquetype

psoriasis initiating either ustekinumab or adalimumab as part of routine clinical care.

Exclusion Criteria:

Use of systemic or biological therapy for psoriasis for 2 weeks prior to study entry
Use of PUVA for 3 months or UVB therapy for 1 month prior to study entry
Use of topical treatments (to site of biopsies, except for emollients for 1 week prior to study entry)
Serious/uncontrolled systemic disease or medical condition, including serious infection, TB, HIV.
Pregnancy or lactation
Psychiatric or other disorder that may impact on informed consent

Study is currently open to recruitment – due to close 1/5/2018

Study Contact – Robert Pleass

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