Cost regulators for NHS therapies in England and Wales have now published final guidelines backing the use of LEO Pharma’s Kyntheum as an option for treating severe plaque psoriasis.
Kyntheum (brodalumab), a novel biologic approved in Europe in July last year, is the first and only psoriasis treatment to target the IL-17 receptor.
By binding to this specific receptor on the cells of the skin, the drug blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in plaque formation, offering a different mechanism of action to all other psoriasis biologics currently available, which target free inflammatory mediators.
In the clinical trials, 37-44 percent of patients treated with the drug achieved complete skin clearance (PASI 100) at week 12, compared with 19-22 percent with ustekinumab, with “high levels” of skin clearance sustained with continuous brodalumab treatment through week 52.
NICE has approved NHS funding for Kyntheum as an option for treating plaque psoriasis in adults, but only if the disease is severe, the disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated/not tolerated, and the company provides the drug with the discount agreed in the patient access scheme.
The Institute also stipulated that patients should stop taking the drug at 12 weeks if their psoriasis has not responded adequately, defined as a 75 percent reduction in the PASI score (PASI 75) or a 50 percent cut in the PASI score (PASI 50), and a 5‑point reduction in the Dermatology Life Quality Index from when treatment started.
LEO bought rights to the drug from AstraZeneca in July 2016, in a deal that also included tralokinumab, an anti-IL-13 monoclonal antibody being developed for atopic dermatitis.