Boehringer Ingelheim’s Spevigo (spesolimab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat generalised pustular psoriasis (GPP) flares.

The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales to treat adults with the rare form of psoriasis, giving patients access to a therapy that targets the interleukin-36 pathway for the first time.

GPP is an unpredictable and severe disease characterised by recurrent flares of pustules covering large areas of the body. These flares can be life-threatening due to the potential for serious complications such as sepsis, heart and kidney failure.

Patients are typically given ciclosporin, acitretin and biological treatments used to treat other forms of psoriasis.

Spevigo is a selective antibody that blocks the activation of the interleukin-36 receptor, a signalling pathway within the immune system shown to be involved in the pathogenesis of several auto-inflammatory diseases, including GPP.

NICE’s decision on the drug was supported by positive results from the phase 2 Effisayil 1 trial, which randomised adults with moderate-to-severe GPP flares to receive a single 900mg intravenous dose of Spevigo or placebo.

The proportion of patients who achieved a Generalised Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of zero or one (clear or almost clear skin) was higher in the Spevigo arm, with a risk difference of 46%.

“The committee concluded that the Effisayil 1 trial suggested that [Spevigo] was more effective than placebo in resolving GPP flares,” NICE outlined in its guidance.

Helen McAteer, chief executive of the Psoriasis Association, said the recommendation “marks a major step forward in addressing a significant unmet need for people living with GPP in England and Wales”.

She continued: “This decision offers real hope to patients who have long awaited treatment options and the possibility of greater stability and peace of mind.”