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November 2013
Dimethyl fumarate is intended to be used for the treatment of moderate to severe plaque psoriasis. If licensed dimethyl fumarate may present an additional treatment option for this patient group, potentially delaying or avoiding the need for biological therapies. Dimethyl fumarate is one of three fumaric acid salts present in Fumaderm, a drug already licensed in Germany for plaque psoriasis.
This briefing is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement on the safety, efficacy or effectiveness of the health technology covered and should not be used for commercial purposes or commissioning without additional information.
Plaque psoriasis is the most common type of psoriasis, representing 90% of cases. The estimated UK prevalence of psoriasis is 1.5-1.63%, with 1.1% of suffering with severe disease. It has a bimodal onset, with the first peak occurring in persons aged 16 to 22 years, and the second in persons aged 57 to 60 years. The prevalence of psoriasis in those younger than 10 years is estimated to be 0.55% and 1.4% in those aged between 10 and 19 years. The estimated prevalence of people currently eligible for biological therapy in England is 1.1% of those with psoriasis. Chronic plaque psoriasis is typified by itchy, well demarcated circular-to-oval bright red/pink elevated lesions (plaques) with overlying white or silvery scale, distributed symmetrically over extensor body surfaces and the scalp. Current treatment options include topical ointments and emollients, phototherapy, systemic therapies (e.g. oral retinoids) and biological therapies. Dimethyl fumarate is currently in a phase III clinical trial comparing its effect on psoriasis area and severity index (PASI) against treatment with Fumaderm or placebo. This trial is expected to complete in December 2014.
This briefing presents independent research funded by the National Institute for Health Research (NIHR). The views expressed are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. NIHR Horizon Scanning Centre, University of Birmingham Email: nihrhsc@contacts.bham.ac.uk Web: http://www.hsc.nihr.ac.uk
TECHNOLOGY DESCRIPTION
Dimethyl fumarate (LAS-41008) is a methyl ester of fumaric acid. Fumaric acid and its sodium salts have been previously used in psoriasis, and dimethyl fumarate appears to be the most active compound when given orally. Dimethyl fumarate inhibits certain functions of endothelial cells, namely, differentiation, proliferation and migration, as well as affecting the immune system and proliferating cells in general. Dimethyl fumarate is administered at a starting dose of 30mg daily, titrated up to a maximum of 720mg daily. Dimethyl fumarate is also in development for multiple sclerosis. It is also one of three fumaric acid salts present in Fumaderm, which is currently licensed for the treatment of plaque psoriasis in Germany.
DEVELOPER
Almirall SA.
Other Guidance The Canadian Guidelines for the Management of Plaque Psoriasis. Consensus guidelines for the management of plaque psoriasis. 2012 15. American Academy of Dermatology. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: Case-based presentations and evidence-based conclusions. 20111. SIGN. Diagnosis and management of psoriasis and psoriatic arthritis in adults. 2010 16. British Association of Dermatologists and Primary Care Dermatology Society. Clinical guideline: Recommendations for the initial management of psoriasis. 2009 17.
Unit Cost 352 (40mg, prefilled syringe) 89 (25mg, prefilled syringe) 420 (100mg vial) 2147 (45mg, prefilled syringe)
IMPACT - SPECULATIVE
Impact on Patients and Carers
Reduced mortality/increased length of survival Other Reduced symptoms or disability No impact identified
Impact on Services
Increased use of existing services Decreased use of existing services: oral treatment option. Fumaderm is also currently used off-licence in most UK departments to control chronic plaque psoriasis. This may negate the need for specialist training in order b to initiate and prescribe this therapy . Need for new services None identified
a Based b
Other Issues
Clinical uncertainty or other research question identified: Expert opinion suggests it would be beneficial to have more data on the efficacy of dimethyl fumarate in a paediatric population and to determine how immunosuppressive the therapy is in relation to other systemic agents for plaque psoriasis (e.g. methotrexate). There are also a number of other oral drugs in c development for plaque psoriasis . None identified
REFERENCES
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