The aim of this project, which has been commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Fast Track Appraisal process [or Single Technology Assessment – to be determined], is to review the submission of the pharmaceutical company (AbbiVie) on the evidence for the clinical effectiveness and cost comparison of risankizumab (Skyrizi) for adults with moderate to severe plaque psoriasis.  

The company’s clinical effectiveness evidence consists mainly of 4 phase III RCTs (with a total of about 2,200 adults with plaque psoriasis), which compared risankizumab with placebo and ustekinumab (NCT02684370 – the UltIMMa-1 trial; and NCT02684357 – the UltIMMa-2 trial), with adalimumab (NCT02694523 - the IMMvent trial) and with placebo (NCT02672852 - the IMMhance trial). The co-primary endpoints were the proportion of participants who achieved 90% reduction in the Psoriasis Area and Severity Index (PASI) score from the baseline to week 16 and the proportion of participants who achieved a static Physician’s Global Assessment (sPGA) score of clear or almost clear (0 or 1) at week 16.  

The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical effectiveness evidence and cost-comparison submitted by the company. Based on the findings of the company submission and of the ERG’s critique, NICE has released appropriate clinical guidance (published 21 August 2019). NICE recommends risankizumab as an option for treating plaque psoriasis in adults, only if the disease is severe (total PASI of 10 or more and a Dermatology Life Quality Index of more than 10) and has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or when these options are contraindicated or not tolerated and only if the company provides the drug according to the commercial arrangement. Risankizumab treatment should be stopped at 16 weeks if the psoriasis has not responded adequately.

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Miriam Brazzelli;