Recommendations for research

The guideline development group has made the following recommendations for research.

1 Assessment of disease severity and impact

In children, young people and adults with psoriasis, can tools be developed and/or existing ones further refined and validated to:

  • assess disease severity and impact in both non-specialist and specialist healthcare settings, to facilitate assessment, appropriate referral, treatment planning and measurement of outcomes

  • measure burden and cumulative effect of disease activity, severity and impact for people with both psoriasis and psoriatic arthritis?

Why this is important

Assessment of disease severity and impact is fundamental to delivering high-quality health care and measuring outcomes. The evidence review indicates that the existing tools have important limitations, and have not been validated in relevant healthcare settings or in children or young people. Future research should ensure that tools are developed that capture information on site of involvement as well as extent and the impact of previous treatments. Tools should capture all aspects of impact on life including physical, psychological and social wellbeing and factors that may influence this impact, such as distress and beliefs about psoriasis. Tools that can be used by patients (as well as healthcare professionals) to assess disease severity and that encompass new technologies should be evaluated to facilitate, when appropriate, modern healthcare delivery models (for example, remote monitoring of disease activity).

In addition, understanding the true burden and effect of disease activity, severity and impact for both psoriasis and psoriatic arthritis has not previously been comprehensively studied. Capturing this information and distilling out significant factors for focused investigation will lead to better understanding of the needs of this particular group of people and the impact of treatments that benefit both disease compartments (skin and joints).

2 Methotrexate and risk of hepatotoxicity

What is the impact of methotrexate compared with other approaches to care (for example, other systemic non-biological or biological treatments) on risk of significant liver disease in people with psoriasis and do risk factors such as obesity, alcohol use or diabetes alter this risk?

Why this is important

The evidence review indicates that people with psoriasis may be at risk of liver disease, and there is great uncertainty about the contributing role of methotrexate. Clinician and patient concerns about this side effect are a common cause of treatment discontinuation. However, existing studies are poorly controlled for important confounders and many are very old. Methotrexate is a low-cost intervention that is effective in an important proportion of patients. Research in this area will properly delineate the size of risk and how to minimise it. Future research should be adequately powered to detect clinically relevant liver disease, use relevant tools to do so, and properly control for relevant confounders.

3 Rapid escalation to systemic treatments

In people with psoriasis, does early intervention with systemic treatments improve the long-term prognosis of psoriasis severity, comorbidities (including psoriatic arthritis), or treatment-related adverse effects, and are there any clinical (for example, demographic or phenotypic) or laboratory (for example, genetic or immune) biomarkers that can be used to identify those most likely to benefit from this treatment approach?

Why this is important

At present the treatment pathway for people with psoriasis follows clinical need as no studies have been conducted to evaluate whether early intervention with systemic treatments alters prognosis. Consequently, patients with more severe disease sequence through all therapies in the treatment pathway, with a proportion requiring high-cost biological interventions to maintain disease control. The evidence indicates that there are very few treatment options for people with chronic disease, all of them are associated with side effects, many are co-dependent (for example, escalated risk of skin cancer in people treated with the phototherapy and ciclosporin sequence), and loss of response to biological therapies is a significant clinical issue. If early intervention with systemic treatments was shown to alter the prognosis, particularly if there were markers that could stratify those likely to benefit, this would be of major importance to patients, and likely to deliver much more cost-effective treatment strategies.

4 Self-management

Do structured psoriasis-focused self-management programmes improve patient confidence, wellbeing and disease control compared with standard care?

Why this is important

Virtually all patients self-manage their condition to a greater or lesser extent, and this involves complex topical applications as well as systemic therapies to be used over many years in response to fluctuating disease severity. The evidence indicates that in contrast to many chronic disorders, there are no validated programmes to help patients achieve effective self-management. Establishing a focused programme that effectively improves outcomes for patients would be of clinical benefit and likely deliver healthcare savings.

5 Topical therapy

In people of all ages with psoriasis:

1. How should topical therapies be used to maintain disease control i) safely; ii) effectively and iii) what are the health economic implications?

2. What are the risks of 'real life' long-term corticosteroid use, are there particular people at risk and what strategies can be used to modify or avoid risks?

Why this is important

Currently, topical therapies, in some form or another, are prescribed to virtually everyone with psoriasis, often as first line psoriasis treatment and they are also frequently used adjunctively with other interventions. There is a wide array of potential topical agents available and further research specifically targeting therapeutic strategies together with sequencing of topical agents for maintaining disease control in the long term continues to deserve focused attention. In addition, exploration of the risks associated with long-term corticosteroid use and strategies aimed at modifying risk would be a critical element of this research to fill the current gap in the literature.