Ointment more effective than recently NICE–approved biologics, given as injections in treating severe psoriasis, new study suggests
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A routinely prescribed ointment applied once a day, which is a combination of two existing treatments for psoriasis – calciptriol and betamethasone dipropionate – is more effective in the severe form of the condition than some recently NICE-approved biological treatments, according to a new study published today in the leading skin journal the International Journal of Dermatology.

This new analysis looks at results of carefully controlled clinical trials for different psoriasis treatments in the severe form of the condition – the combination ointment, and three of the biological therapies, relatively recently introduced monoclonal antibody therapies, which are administered by injection and cost between £2030 and £4290 per treatment course1.

In this new assessment, a retrospective analysis of six studies involving 2,452 patients treated with the calcipotriol and betamethasone dipropionate combination ointment, demonstrated that in the 261 patients with severe psoriasis, 88.8% improved by 50% or more after four weeks of treatment. Analysis of a further five, double-blind, placebo controlled trials of biological treatments involving 1703 patients, demonstrated that 56%, 59% and 74% improved by 50% or more after 12 weeks in patients treated with alefacept, efalizumab and etanercept respectively. Everyone who entered the biologic trials had severe psoriasis at treatment commencement2.

"Because people's skins are different and respond differently to different treatments, it is essential that the widest range of treatments for skin diseases such as psoriasis should be available on prescription at appropriate levels within the NHS." commented Peter Lapsley, Chief Executive of the Skin Care Campaign.

The recent adoption of a standardised measure of success in clinical trials has meant that for the first time, the number of people reaching a successful outcome following carefully defined criteria, can be compared for different types of psoriasis medications.

This assessment comes shortly after NICE, the National Institute for Health and Clinical Excellence, the NHS’s drug watchdog, approved two biological treatments for the severe form of the disease when routinely used treatments are ineffective or cannot be tolerated by the patient. This highlights the need for the availability of a range of treatments which the clinician can select on the basis of the individual patients’ needs.

-Ends-

Notes to editors

  • Although the studies performed had slightly different exclusion criteria, all specified that patients had chronic plaque psoriasis involving ≥ 10% of one or more body regions. This retrospective analysis sought to compare the results from patients with similar disease severity at baseline in the topical ointment studies and the biological studies1
  • This analysis makes use of the recent recommendation by the US National Psoriasis Foundation – the leading patient and professional organisation in the USA – that the PASI (Psoriasis Area and Severity Index) 50* and PASI 75* response rates be used as success criteria in all clinical trials, to enable comparisons to be made across studies of different therapies2.
  • The Psoriasis Area and Severity Index (PASI), is based on an assessment of body surface area, together with signs of redness (erythema), thickness (induration) and scaling (desquamation) and has been used for 25 years to evaluate the severity of psoriasis, and provide a measure of treatment response in clinical trials2
  • In the studies on the calcipotriol/betamethasone ointment, data was pooled from six randomised, double-blind, comparative trials. Of these, two trials used twice daily application, three trials used once daily application and one trial used both once and twice daily application regimens. In the UK, this product is licensed for once daily application.
  • In studies on the biological therapies, data was derived from five randomised, double-blind, placebo-controlled trials. Subjects received either alefacept (n=367, one study) as a once weekly, IV dose of 7.5mg for 12 weeks, efalizumab (n=1172, three studies) 1.0 or 2.0 mg/kg/week by subcutaneous injection for 12 weeks, or twice weekly 50mg subcutaneous injections of etanercept (n=164, one study) 2
  • Not all biological therapies are represented in this comparison.
  • Psoriasis affects approximately 1.2 million people in the UK3
  • Chronic plaque psoriasis is the most common form and it is characterised by raised red plaques which are often painful, itchy and unsightly, it can affect the scalp, face and hands and can cause particular distress to people affected4
For More information please contact:

Laura Anderson
0208 956 2286
[email protected]

Lucy Howell
0208 956 2298
[email protected]

References

  1. MIMS; August 2006
  2. Anstey, A; Kragballe, K. 2006. Retrospective assessment of PASI 50 and PASI 75 attainment with a calcipotriol / betamethasone dipropionate ointment. International Journal of Dermatology. 2006; 45(8):970-5.
  3. All Party Parliamentary Group on Skin. Report on the enquiry into the impact of skin diseases on people’s lives 2003
  4. Fry L. An Atlas of Psoriasis. 2nd edition. London: Taylor & Francis, 2004; 7: 7, 13, 33, 40, 75, 89