What s new in psoriasis? An analysis of guidelines and systematic reviews published in

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1 Clinical dermatology Review article CED Clinical and Experimental Dermatology CPD What s new in psoriasis? An analysis of guidelines and systematic reviews published in A. C. Foulkes, D. J. C. Grindlay,* C. E. M. Griffiths and R. B. Warren Dermatology Centre, Salford Royal NHS Foundation Trust, University of Manchester, Manchester, Academic Health Science Center M6 8HD, UK; and * NHS Evidence Skin Disorders, Centre of Evidence Based Dermatology, University of Nottingham, Nottingham, UK doi: /j x Summary This review summarizes key clinical findings from 5 guidelines and 21 systematic reviews on psoriasis published or indexed in the period November 2009 to October The highlights include the British Association of Dermatologists guidelines on the use of biological interventions in psoriasis, and guidelines on the efficacy and use of acitretin. Biological therapies were reviewed for use in specific patient groups (such as those with hepatitis C) and from a health-economics perspective. Another systematic review focused on outcome measures used to assess the severity of psoriasis. Finally, comorbidities including cardiovascular risk were the topic of four systematic reviews. Background This review summarises key findings from 5 guidelines and 21 systematic reviews on psoriasis, which were indexed in bibliographic databases between November 2009 and October 2010, and included in the 2010 Annual Evidence Update on Psoriasis from NHS Evidence skin disorders. The aim is to pick out clinically Correspondence: Dr Amy Foulkes, Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester Academic Health Science Centre, University of Manchester, Manchester, M6 8HD, UK amy.foulkes@manchester.ac.uk Conflict of interest: All authors work in the UK National Health Service (NHS), which funds NHS Evidence. RBW has acted as a consultant and or speaker for Abbott, Janssen Cilag, Leo Pharma, Pfizer and Schering-Plough, all of which manufacture therapies used in the treatment of psoriasis. CEMG has received research support and or has acted as a consultant or lecturer for Abbott, Amge, Biogen-IDEC, Centocor, Essex Pharma, Galderma, Janssen-Cilag, Leo Pharma, Novartis, Novo Nordisk, Schering-Plough, Merck- Serono, Stiefel, UCB Pharma, Wyeth and BioTest. A similar and more detailed review to the material published here appeared in the 2010 Annual Evidence Update on Psoriasis published by NHS Evidence website and explicit reference is given to that fuller version throughout. There are no copyright issues with using material from that source. Accepted for publication 14 February 2011 important points with the busy clinician in mind. Readers are encouraged to view the full report and original papers cited in the 2010 Annual Evidence Update ( aspx?resid=390037&tabid=289&catid=8398), where the methods and omitted citations are given. This review considers guidelines and systematic reviews only, as they are generally considered to be the most reliable evidence base for clinical practice. Reviews summarising previous Annual Evidence Updates on psoriasis have been published previously in this journal. 1,2 UK guidelines The British Association of Dermatologists (BAD) published guidelines for biological interventions for psoriasis in Patients with psoriasis may be considered eligible to receive treatment with any of the four licensed biological interventions when they fulfil specific eligibility criteria comprising: (i) severe clinical disease, defined as Psoriasis Area Severity Index (PASI) of 10 and Dermatology Life Quality Index (DLQI) of 10; and (ii) a clinical category of disease for which (a) phototherapy and alternative standard systemic therapy are CED Ó 2011 British Association of Dermatologists Clinical and Experimental Dermatology, 36,

2 contraindicated, (b) there is intolerance to standard systemic therapy, or (c) there is lack of response to standard systemic therapy. An adequate response to treatment was defined as either 50% reduction in baseline PASI (PASI50) and a decrease of 5 points in DLQI, or a 75% reduction in baseline PASI (PASI75). The guidelines serve as a vital resource for information on the initiation and use of biological therapies in a variety of clinical scenarios, e.g. relevant screening, chronic viral infections and use in pregnancy. It is interesting to note that the BAD guidelines did not distinguish different eligibility criteria for infliximab, as is the case with guidance from the National Institute for Health and Clinical Excellence (NICE), 4 which states that to qualify for this particular drug, a patient needs very severe disease (PASI of 20 and DLQI of 18). At the time of that publication, adalimumab or etanercept were considered first-line biologicals, with ustekinumab being reserved as a second-line agent and infliximab advised when more rapid disease control is required. As with any guidelines, it is important to consider literature published after the guidelines; for example, as greater long-term safety data emerge for ustekinumab, this may in time alter its positioning. The BAD also published guidelines on the efficacy and use of acitretin in Already a popular second-line systemic agent in the treatment of severe psoriasis, the guidelines reviewed evidence for its use in all dermatological disease. Acitretin monotherapy was recommended in the treatment of severe psoriasis, palmoplantar pustulosis, hyperkeratotic hand eczema, severe Darier s disease (keratosis follicularis), severe congenital ichthyosis, and keratoderma. Evidence was presented that the conditions benefiting from the antimitotic and keratolytic actions of acitretin include lichen planus, lichen sclerosus, discoid lupus erythematosus, and prevention of cutaneous malignancies in recipients of organ transplants. Preliminary investigations required before starting acitretin were summarized, and a detailed monitoring process was provided. National Health Service Clinical Knowledge Summaries (CKS; formerly PRODIGY) are a source of evidencebased information and practical knowledge about the common conditions managed in primary care. The new CKS Psoriasis topic 6 is a thorough resource that could prove useful to both patients and healthcare professionals. It includes a useful lay summary (which can alternatively be viewed as a patient-information leaflet) and a detailed guide to psoriasis management in primary care, which links to the supporting evidence. International guidelines The American Academy of Dermatology has produced guidelines on the use of phototherapy for the treatment of psoriasis. 7 Although an extensive review of literature has been summarized, prescriptive protocols are used, and these do not reference essential dosimetry and calibration, unlike the 2002 British Photodermatology Group guidelines. 8 Severity and outcome measures A systematic review of the best outcome measures for assessing plaque psoriasis severity suggests that the PASI is the most extensively studied clinical severity score and also the most thoroughly validated according to methodological criteria. 9 The same criteria were also used to assess outcome measures of quality of life in plaque psoriasis, with the conclusion that the DLQI is the easiest to use in clinical practice. 10 Comorbidities Mounting evidence for an association between cardiovascular disease (CVD) and severe psoriasis was found in a review of 14 studies on this topic, 11 concluding that there is a substantial increased risk of CVD in patients with both psoriasis and psoriatic arthritis (PsA). An increased risk for both obesity and metabolic syndrome was found by Prey et al. 12 in their review of 18 cross-sectional case control studies of patients with solely plaque-type psoriasis. Bremmer et al. 13 published a review on obesity and psoriasis, which concluded that the amount of category I evidence for objectively determining the best treatment choices for obese patients with psoriasis was scarce, considering the relative risk associated with therapeutic options in those with obesity as a comorbidity. An investigation of the prevalence of psoriasis in multiple sclerosis 14 found conflicting data from an evaluation of 19 articles. Despite the previous hypothesis that these diseases may be associated because of common immunopathogenic factors such as the dysregulation of the T-helper (Th)17 cell pathway, it was concluded that an association could not be established from published literature. Estimates of the prevalence of PsA in psoriasis vary widely, in the range 5 40%. 15 The time to development of PsA in patients with plaque psoriasis also remains unclear. A review of eight epidemiological studies by Prey et al. 16 suggested a prevalence of 7 26% on examination using rheumatologically validated criteria. 586 CED Ó 2011 British Association of Dermatologists Clinical and Experimental Dermatology, 36,

3 Erythrodermic psoriasis There are few evidence-based data to guide clinicians in managing the challenge of erythrodermic psoriasis. Rosenbach et al. 17 evaluated the therapeutic options available, and suggested that the paucity of high-quality scientific data indicated a need for dedicated clinical trials. However, these authors searched only PubMed, so some trials might have been missed in other databases such as EMBASE. Conclusion In conclusion, systematic reviews over the last year have once again focused on the use of biologicals for the treatment of psoriasis, although this has now been expanded to their use in subgroups of patients such as those with viral or retroviral disease. In the current economic climate, we may expect to see further pharmacoeconomic analyses of the use of biological therapies. Therapies for psoriasis in specific patient groups Frankel et al. 18 reviewed the treatment of patients with psoriasis with concomitant hepatitis C virus (HCV), an important issue, as interferon-a can trigger and or worsen psoriasis. Data indicate that ciclosporin A can contribute to a good outcome in patients with psoriasis and concomitant HCV, in terms of both safety and efficacy. The authors noted that further investigations of safety are required. Acitretin, psoralen ultraviolet A and anti-tumour necrosis factor-a agents were suggested as second-line agents. For patients with psoriasis and concomitant human immunodeficiency virus (HIV) infection, treatments have been considered by a task force of the US National Psoriasis Foundation Medical Board. 19 Acitretin was proposed as a safe second-line agent. Interestingly, biologicals have been used in series of patients with both HIV and rheumatoid arthritis, with some success. It was reinforced that this approach should be reserved for those with debilitating disease, and should remain a joint management decision with specialists in infectious diseases. Learning points The BAD has published guidelines on the use of biologicals in psoriasis. Recommendations include the use of ustekinumab in patients who fulfil the stated disease criteria, and for whom TNF antagonist therapy has failed or is contraindicated. The BAD has published guidelines on the use of acitretin; recommended monitoring includes assessment of liver enzymes and fasting serum cholesterol and triglycerides every 2 4 weeks for the first 2 months of treatment, and then every 3 months. PASI remains the best-validated outcome measure for assessing chronic plaque psoriasis, although its weaknesses include its poor sensitivity at the lower end of the scale. The relationship between cardiovascular risk and chronic plaque psoriasis is complex, and a true association remains to be established. There are few evidence-based data to guide clinicians in the management of erythrodermic psoriasis. Biological therapies A study on economic factors in the use of biological agents used pharmacoeconomic analyses with numerous limitations, as drug toxicity and long-term efficacy were not taken into account. 20 Evidence Review Group report summaries were produced for NICE by Gospodarevskaya et al. on the use of ustekinumab to treat moderate to severe psoriasis 21 and by Turner et al. for adalimumab. 22 The resulting NICE guidance stated that ustekinumab is recommended as a treatment option for adults with severe plaque psoriasis (PASI 10; DLQI 10) unresponsive to standard systemic therapy, 23 and adalimumab as a treatment option for adults with severe plaque psoriasis (PASI 10; DLQI 10) unresponsive to standard systemic therapy. 24 Acknowledgements AF is a Clinical Research Training Fellow funded by the North-west England Medical Research Council Clinical Research Training Fellowship in Clinical Pharmacology and Therapeutics. CEMG is supported in part by the National Institute for Health Research (NIHR) Manchester Biomedical Research Centre. RBW is an NIHR Senior Clinical Lecturer. References 1 Brown BC, Warren RB, Grindlay DJ, Griffiths CEM. What s new in psoriasis? Analysis of the clinical significance of CED Ó 2011 British Association of Dermatologists Clinical and Experimental Dermatology, 36,

4 systematic reviews on psoriasis published in 2007 and Clin Exp Dermatol 2009; 34: Warren RB, Brown BC, Grindlay DJ, Griffiths CEM. What s new in psoriasis? Analysis of the clinical significance of new guidelines and systematic reviews on psoriasis published in 2008 and Clin Exp Dermatol 2010; 35: Smith CH, Anstey AV, Barker JNWN et al. British Association of Dermatologist s guidelines for biologic interventions for psoriasis Br J Dermatol 2009; 161: National Institute for Health and Clinical Excellence. Infliximab for the Treatment of Adults with Psoriasis. London: NICE, Ormerod AD, Campalani E, Goodfield MJD. British Association of Dermatologists guidlines on the efficacy and use of acitretin in dermatology. Br J Dermatol 2010; 162: Clinical Knowledge Summaries (CKS), Psoriasis Available at: (accessed 17 May 2011) 7 Menter A, Korman NJ, Elmets CA et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy. J Am Acad Dermatol 2009; 62: Taylor DK, Anstey AV, Coleman AJ et al. British Photodermatology Group. Guidelines for dosimetry and calibration in ultraviolet radiation therapy: a report of a British Photodermatology Group workshop Guidelines for dosimetry and calibration in ultraviolet radiation therapy: a report of a British Photodermatology Group workshop. Br J Dermatol 2002; 146: Puzenat E, Bronsard V, Prey S et al. What are the best outcome measures for assessing plaque psoriasis severity? A systematic review of the literature. J Eur Acad Dermatol Venereol 2010; 24 (Suppl. 2): Bronsard V, Paul C, Prey S et al. What are the best outcome measures for assessing quality of life in plaque type psoriasis? A systematic review of the literature. J Eur Acad Dermatol Venereol 2010; 24 (Suppl. 2): Tobin AM, Veale DJ, Fitzgerald O et al. Cardiovascular disease and risk factors in patients with psoriasis and psoriatic arthritis. J Rheumatol 2010; 37: Pre S, Paul C, Bronsard V et al. Cardiovascular risk factors in patients with plaque psoriasis. A systematic review of epidemiological studies. J Eur Acad Dermatol Venereol 2010; 24 (Suppl. 2): Bremmer S, van Voorhees AS, Hsu S et al. Obesity and psoriasis: from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol 2010; 63: Kwok T, Jing Loo W, Guenther L. Psoriasis and multiple sclerosis: is there a link? J Cutan Med Surg 2010; 14: Christophers E, Barker JNWN, Griffiths CEM et al. The risk of psoriatic arthritis remains constant following initial diagnosis of psoriasis among patients seen in European dermatology clinics. J Europ Acad Dermatol Venereol 2010; 24: Prey S, Paul C, Bronsard V et al. Assessment of risk of psoriatic arthritis in patients with plaque psoriasis: a systematic review of the literature. J Eur Acad Dermatol Venereol 2010; 24 (Suppl. 2): Rosenbach M, Hsu S, Korman NJ et al. National Psoriasis Foundation Medical Board. Treatment of erythrodermic psoriasis: from the medical board of the National Psoriasis Foundation. J Am Acad Dermatol 2010; 62: Frankel AJ, van Voorhees AS, Hsu S et al. National Psoriasis Foundation. Treatment of psoriasis in patients with hepatitis C. from the Medical Board of the National Psoriasis Foundation. J Am Acad Dermatol 2009; 61: Menon K, van Voorhees AS, Bebo BF Jr et al. National Psoriasis Foundation. J Am Acad Dermatol 2010; 62: Poulin Y, Langley RG, Teixeira HD et al. Biologics in the treatment of psoriasis: clinical and economic overview. J Cutan Med Surg 2009; 13 (Suppl. 2): S Gospodarevskaya E, Picot J, Cooper K et al. Ustekinumab for the treatment of moderate to severe psoriasis. Health Technol Assess 2009; 13 (Suppl 3): Turner D, Picot J, Cooper K et al. Adalimumab for the treatment of psoriasis. Health Technol Assess 2009; 13 (Suppl 2): National Institute for Health and Clinical Excellence (NICE). Ustekinumab for the Treatment of Adults with Moderate to Severe Psoriasis. London: NICE, National Institute for Health and Clinical Excellence (NICE). Adalimumab for the Treatment of Adults with Psoriasis. London: NICE, CPD questions Learning objective The purpose of this activity is to review new guidelines and systematic reviews on psoriasis published or indexed from November 2009 to October 2010 and to demonstrate up-to-date knowledge on psoriasis. Question 1 Which of the following dermatological diseases would you consider treating with oral acitretin, according to the British Association of Dermatologists guidelines on its use? a) Severe psoriasis b) Mild atopic eczema 588 CED Ó 2011 British Association of Dermatologists Clinical and Experimental Dermatology, 36,

5 c) Acne vulgaris d) Viral warts e) Basal cell carcinoma Question 2 Which is the most studied outcome measure for assessing the severity of chronic plaque psoriasis? a) SCORAD b) PASI c) DLQI d) PGA e) PsARC Question 5 Which of the following statements is recommended in US guidelines as best management for patients with severe psoriasis and human immunodeficiency virus infection? a) Patients should always be managed with anti-tumour necrosis factor-a therapy b) Patients should be jointly managed by a dermatologist and a specialist in infectious diseases c) Patients should be admitted for inpatient treatment d) Patients should always be treated with ustekinumab e) Phototherapy is the best option Question 3 The National Institute of Health and Clinical Excellence issued guidance that ustekinumab was indicated in patients with which combination of the following scores? a) PASI > 5; DLQI > 10 b) PASI > 10; DLQI > 10 c) PASI 10; DLQI 10 d) PASI > 20; DLQI > 10 e) PASI 20; DLQI 10 Question 4 Which of the following treatments is known to trigger worsen psoriasis in patients with concomitant viral hepatitis? a) Ribavirin b) Lamivudine c) Interferon-a d) Adefovir e) Entecavir Instructions for answering questions This learning activity is freely available online at Users are encouraged to Read the article in print or online, paying particular attention to the learning points and any author conflict of interest disclosures Reflect on the article Register or login online at com and answer the CPD questions Complete the required evaluation component of the activity Once the test is passed, you will receive a certificate and the learning activity can be added to your RCP CPD diary as a self-certified entry. CED Ó 2011 British Association of Dermatologists Clinical and Experimental Dermatology, 36,