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by James Thomas, Tuesday, October 10, 2017 | Categories: Skin and Nails

NICE Begins Approval Process for New Treatment for Severe Psoriasis

Draft guidelines that back the use of Almirall’s new product Skilarence, for the treatment of moderate or severe plaque psoriasis by the National Health Service in the United Kingdom, have been issued by the National Institute for Health and Care Excellence (NICE). The drug is being recommended for use by the Institute only in those adults who have the severe form of the disease or are unable to take, or have failed to respond to, different systemic non-biological treatments.

Psoriasis: What is it?

There are a number of different kinds of psoriasis, with most people only having one at any particular time, although it is possible for two different kinds to strike at once. Some can actually change into a different type, or end up becoming more serious. The great majority of psoriasis cases go through cycles, often causing difficulties for sufferers for several weeks or months but then stopping or easing. If you believe you may be suffering from psoriasis then you should see your GP or start a consultation here.

Psoriasis types

The most common type of psoriasis is plaque psoriasis, which presents with symptoms such as red, dry skin lesions that are covered with silver scales. These lesions are referred to as plaques and generally materialise on the elbows, scalp, lower back and knees but can actually appear anywhere on the body. These plaques can be sore or itchy or sometimes both, and the skin around joints may bleed and crack in severe cases.

Another form of psoriasis is scalp psoriasis, which can only appear on the scalp and in some cases may even cover the whole area. This form of psoriasis results in red skin patches that are covered with silvery-white thick scales. In some cases the patches cause no discomfort, but some people can find them extremely itchy. Hair loss can be the result in extreme cases, but this is normally a temporary effect.

Fifty percent of people afflicted with psoriasis develop nail psoriasis, which as the name suggests affects the nails. Tiny pits or dents can develop in the nails, and they may grow in an abnormal manner or become discoloured. Nails may also loosen from the nail bed and in severe cases crumble.

Gutatte psoriasis results in small drop-shaped sores appearing on the arms, legs, scalp and chest, and sometimes develops following a streptococcal throat infection. Many cases disappear in a couple of weeks but sufferers can go on to develop plaque psoriasis. It is particularly common in teenagers and children.

Inverse psoriasis affects the creases or folds of the skin, such as underneath breasts, between buttocks and around the groin and armpits, resulting in smooth, large red patches. Sweating and friction worsen the condition, making it particularly irritating during hotter weather.

Other, less common forms of psoriasis include pustular psoriasis, where blisters filled with pus appear on the skin; generalised pustular psoriasis, which also causes blisters and can cause chills, fatigue, fever and weight loss; palmoplantar pustular psoriasis, where pustules appear on the soles of the feet and the palm of the hands; acropustulosis, where pustules materialise on toes and fingers; and erythrodermic psoriasis, a very rare form where all the body’s skin can be affected, causing intense burning or itching and sometimes resulting in additional problems such as dehydration, hypothermia, malnutrition, infection and even heart failure.

The recommendation

The National Institute for Health and Care Excellence says that the results of clinical trials have demonstrated that Skilarence, otherwise known as dimethyl fumarate, is able to improve severe cases of psoriasis more than is the case with placebos. However, it is less effective in indirect comparison with systemic biological therapies as well as apremilast, otherwise known as Celgene’s Otezia. The drug’s incremental cost ratio, followed up with best supporting care, falls into the threshold of what is deemed a cost-effective use of the resources of the NHS in this setting, being £23,115 per QALY gained, in comparison with just best supporting care on its own. 

The recommendation also comes with a further condition, that the Skilarence treatment should be halted after sixteen weeks in the event of an inadequate response. This is defined as a reduction of 75 percent in the PASI score from the commencement of treatment, or a reduction of 50 percent in the same score, coupled with a reduction of five points within the Dermatology Quality of Life index. An estimated 951,000 people in the whole of England suffer from psoriasis, with 90 percent of those suffering from plaque psoriasis.

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