Biologics, safety and you

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Your current treatment

Are you currently being treated with a biologic agent for your psoriasis? If yes, it is likely that you have been prescribed one of the following treatments:

adalimumab (Humira®)
etanercept (Enbrel®)
infliximab (Remicade®)
ustekinumab (Stelara®) (most recent addition)

These biologic treatments are relatively new entrants into the field of psoriasis management and are designed to resemble normal human molecules hence the term ‘biologic’. They are proteins derived from human or animal, rather than artificial chemicals, much in the way that insulin was made from animal sources in the past.

It is thought that overactive cells in the immune system set off a series of events in the body, eventually causing psoriasis to develop on the skin and/or arthritis symptoms to develop in the joints. In psoriasis certain T (thymus) cells are mistakenly activated and they move into the skin. Once in the skin they begin to act as if they are fighting an infection or healing a wound and this results in a rapid growth of skin cells. In psoriasis, skin cells grow much faster than normal and this overproduction causes cells to pile up at the skins surface.

Some biologics act by preventing the activation and/or migration of T cells, by reducing the number of psoriasis involved T cells in the body, or both. Others work by blocking the action of chemical messengers released by activated T cells, particularly.

TNF-alpha (tumour necrosis factor alpha). The messages communicated by TNF-alpha lead to the rapid growth of skin cells found in psoriasis and/or to the joint pain and stiffness associated with psoriatic arthritis.

The biologic medications are very expensive and so they have been the subject of a lot of investigations with doctors being advised when they should be administered. They cost up to £10,000 per patient per year, only work in a proportion of patients and their long term safety has not yet been established. As a result they are not considered first line therapy.

Who gets biological therapy?

Depending on the individual guidance and licence indications biological therapies are prescribed for moderate to severe psoriasis only if the psoriasis has not responded to standard systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet radiation), or the person is intolerant of or has a contraindication to these treatments. The definition of moderate to severe psoriasis is based on both objective measures of psoriasis (i.e.: a score of 10 or more for the Psoriasis Area and Severity Score - PASI?, and a measure of how the psoriasis is affecting a patient’s quality of life (i.e.: a score of >10 on the Dermatology Quality of Life Index (DLQI)).

In a recent costing statement (ref 1) for the use of ustekinumab the National Institute for Health and Clinical Excellence - NICE estimated the following:

“Using an estimate of 1.63% for the prevalence of psoriasis in the UK (ref 2) and assuming that 1.1% of people with psoriasis are eligible for treatment with a biological therapy, (ref 3) an estimated 7100 people in England would be eligible to receive a biological therapy for their psoriasis. Clinical opinion suggests that approximately 50% (ref 4) (3550) of these people may actually receive a biological therapy…”

Biologics register

The British Association of Dermatologists - BAD is the professional organisation for consultant, trainee and staff and associate specialist dermatologists in the UK and Eire.

Established in 1920, it is a registered charity with an incorporated body of trustees, the executive committee, who are all dermatologists elected by the membership. The Officers, supported by the professional staff, carry out the day to day business from Willan House, the headquarters building in central London.

The BAD works with many other organisations to achieve its aims of supporting patients and improving standards; these include patient support groups, special interest groups, international dermatology groups and the medical royal colleges.

As part of the process of improving standards and providing education to doctors and patients, the BAD has set up a national register to monitor the use of and collect important data on these biological treatments used to treat psoriasis.

The British Association of Dermatologists' Biologics Register (BADBIR) is a national register of all patients receiving biologic therapy for the treatment of psoriasis in the United Kingdom.

The National Institute for Health and Clinical Excellence (NICE) has recommended that all patients in the UK receiving these new therapies for psoriasis should be registered with BADBIR. The primary aim of the register is to monitor the safety of these drugs.

The purpose of the research study is to assess whether the new biological medications used in the treatment of psoriasis have any side effects (when used long-term in real life) that were not revealed during shorter-term clinical trials. These side effects, if any, will be compared to those seen with established treatments such as ciclosporin, methotrexate and PUVA. The study therefore involves following up patients taking a number of different drugs for psoriasis (and other skin conditions) and assessing the frequency of long-term side effects.

The study design is an epidemiological prospective observational cohort study, comparing patients receiving biologic therapy with those receiving conventional therapy for psoriasis. A similar register, the British Society for Rheumatology Biologics Register (BSRBR), which was set up 5 years ago to investigate use of these biologics in rheumatoid arthritis, has revealed important information on their long term safety and efficacy for this indication.

Clinical data is being collected using a web-based system. BADBIR are also asking patients to complete short questionnaires by post.

If you are currently receiving a biological agent, ask your dermatologist about the register. The BADBIR website gives more information about the register and the centres around the country who are involved in the research.

For further information:
Web: www. badbir .org
Telephone: 0161 306 1896
Email: badbir @ manchester.ac.uk

References:

1. Costing statement: Ustekinumab for the treatment of adults with moderate to severe psoriasis (NICE technology appraisal guidance 180 (TA180)) Available from: www. nice .org.uk/TA180
2. Estimated prevalence of psoriasis obtained from costing template and report for adalimumab for the treatment of adults with psoriasis’ (2008). NICE technology appraisal guidance 146 (TA146). Available from: www. nice .org.uk/TA146
3. Estimated proportion of people with severe psoriasis eligible for biological therapy obtained from costing templates and reports for TA103 and TA146. Available from: www. nice .org.uk/TA103 and www. nice .org.uk/TA146
4. Based on clinical expert opinion

Article uploaded
2 November 2009