1.1 Dimethyl fumarate is recommended as an option for treating plaque psoriasis in adults, only if the disease:
is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
has not responded to other systemic therapies, including, ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated.
1.2 Stop dimethyl fumarate treatment at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as:
a 75% reduction in the PASI score (PASI 75) from when treatment started or
a 50% reduction in the PASI score (PASI 50) and a 5‑point reduction in DLQI from when treatment started.
1.3 When using the PASI, healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.
1.4 When using the DLQI, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties, that could affect the responses to the DLQI and make any adjustments they consider appropriate.
1.5 These recommendations are not intended to affect treatment with dimethyl fumarate that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Clinical trial results showed that dimethyl fumarate improves severe psoriasis more than placebo but, when compared indirectly, it is less effective than systemic biological therapies and apremilast. The modelling of treatment sequences was not considered reliable enough for decision-making. However, the cost effectiveness of dimethyl fumarate followed by best supportive care compared with best supportive care alone was comparable with the respective cost-effectiveness estimates in previously published appraisals of the biologicals and apremilast. Also, dimethyl fumarate is less costly than biologicals and apremilast, and would likely provide sufficient savings per quality-adjusted life years lost when compared with these treatments. Some patients might chose to have dimethyl fumarate. Dimethyl fumarate should be used when the psoriasis is severe and has not responded to other systemic non-biological therapies, or when these treatments cannot be taken.