NICE approves dimethyl fumarate for plaque psoriasis
In final technology appraisal guidance (TA475), NICE has recommended dimethyl fumarate (Skilarence) as an option for the treatment of plaque psoriasis in adults.
NICE recommends treatment with dimethyl fumarate only if the disease is severe and has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA, or if these options are contraindicated or not tolerated. Severe disease is defined as a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10. Treatment should be stopped after 16 weeks if psoriasis has not responded adequately (ie shown a 75% reduction in PASI score (PASI 75), or a PASI 50 and a five-point reduction in DLQI, from when treatment started).
Dimethyl fumarate was licensed in the EU in June for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy. It is an oral treatment, available as 30mg and 120mg gastroresistant tablets. A low dose of 30mg daily is recommended initially, titrated to a maximum dosage of 240mg three times daily, according to tolerability. The list price of dimethyl fumarate is £381.60 per month at the maximum dosage.
The NICE committee considered key clinical evidence from the BRIDGE trial, which compared the efficacy and safety of oral dimethyl fumarate with Fumaderm (an oral fixed combination of fumaric acid esters, unlicensed in the UK) and placebo in 671 patients with moderate to severe chronic plaque psoriasis. The study showed that dimethyl fumarate was noninferior to Fumaderm after four months of treatment in terms of the proportion of patients achieving PASI 75. The most common adverse effects are gastrointestinal symptoms, flushing and lymphopenia.