Risankizumab: A Review in Moderate to Severe Plaque Psoriasis
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ADIS DRUG EVALUATION
Risankizumab: A Review in Moderate to Severe Plaque Psoriasis Hannah A. Blair1
© Springer Nature Switzerland AG 2020
Abstract Risankizumab (Skyrizi®; risankizumab-rzaa) is a humanized immunoglobulin (Ig) G1 monoclonal antibody that specifically targets the p19 subunit of interleukin (IL)-23, thereby inhibiting IL-23-dependent cell signaling. Subcutaneous risankizumab is approved for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy (in the EU), those who are candidates for systemic therapy or phototherapy (in the USA) and those who have an inadequate response to conventional therapies (in Japan). In pivotal phase III trials (UltIMMa-1, UltIMMa-2, IMMvent and IMMhance), risankizumab was more effective than placebo, ustekinumab and adalimumab with regard to the proportion of patients achieving ≥ 90% improvement from baseline in Psoriasis Area and Severity Index score (PASI 90) and a static Physician’s Global Assessment score of 0 or 1 at week 16, with these benefits maintained over the longer term. In supportive head-to-head trials, risankizumab was also superior to secukinumab and fumaric acid esters in terms of PASI 90 response rate. In an ongoing openlabel extension study (LIMMitless), risankizumab was associated with durable and improved efficacy after switching from ustekinumab or adalimumab, as well as durable maintenance of efficacy through > 2.5 years of continuous exposure. Treatment with risankizumab improved health-related quality of life and was generally well tolerated, both in the short- and longer-term. In conclusion, risankizumab represents a useful new treatment option for patients with moderate to severe plaque psoriasis. Risankizumab: clinical considerations in moderate to severe plaque psoriasis Humanized IgG1 monoclonal antibody that binds to and blocks the proinflammatory effects of IL-23 More effective than placebo, ustekinumab, adalimumab, secukinumab and fumaric acid esters in reducing the severity and extent of plaque psoriasis Improves health-related quality of life Generally well tolerated Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12580334. The manuscript was reviewed by: S. R. Feldman, Department of Dermatology, Pathology & Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, USA; L. Puig, Department of Dermatology, Hospital de la Santa Creu I Sant Pau, Barcelona, Spain; T. Torres, Department of Dermatology, Centro Hospitalar Universitario do Porto, Porto, Portugal. * Hannah A. Blair [email protected] 1
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1 Introduction Psoriasis is a chronic immune-mediated inflammatory skin condition that affects 2–3% of the population [1]. Plaque psoriasis is characterized by well-delineated, red, scaly plaques, with disease severity defined partially by the total body surface area (BSA) involved [2]. However, the disease may be severe regardless of
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