Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study


  • Riccardo G. Borroni Department of Biomedical Sciences, Humanitas University, Dermatology Unit, Humanitas Clinical and Research Center – IRCCS, Via Rita Levi Montalcini, 4, IT-20090 Pieve Emanuele MI, Italy
  • Piergiorgio Malagoli
  • Luigi Gargiulo
  • Mario Valenti
  • Giulia Pavia
  • Paola Facheris
  • Emanuela Morenghi
  • Isotta Giunipero di Corteranzo
  • Alessandra Narcisi
  • Michela Ortoncelli
  • Paolo Dapavo
  • Antonio Costanzo



risankizumab, psoriasis, real-life


Risankizumab is a humanized monoclonal antibody that binds the p19 subunit of interleukin-23. It is approved for treatment of moderate-severe chronic plaque psoriasis. This retrospective study included 66 consecutive adults with moderate-to-severe psoriasis vulgaris treated with risankizumab in monotherapy up to week 40 in a “real-life” setting. At week 40, 98.7%, 85.7% and 62.3% of patients achieved a Psoriasis Area and Severity Index (PASI) reduction ≥ 75% (PASI 75), PASI 90 and PASI 100, respectively. Patients who had not responded to 2 or more previous biologic treatments were significantly less likely to achieve PASI 75/90 at week 16 and PASI 90/100 at week 40 compared with those who had been previously treated with only 1 biologic, and compared with those treated with risankizumab as a first-line biologic. Increasing body mass index decreased the chances of reaching PASI 90 at week 40. No significant safety findings were recorded throughout the study, and none of the patients had to interrupt the treatment. These data suggest that the efficacy of risankizumab for plaque psoriasis in “real-life” clinical practice could differ from pivotal clinical trials data.


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Gisondi P, Geat D, Pizzolato M, Girolomoni G. State of the art and pharmacological pipeline of biologics for chronic plaque psoriasis. Curr Opin Pharmacol 2019; 46: 90-99. DOI:

Puig L. The role of IL 23 in the treatment of psoriasis. Expert Rev Clin Immunol 2017; 13: 525-534. DOI:

Gordon KB, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. Lancet 2018; 392: 650-661. DOI:

Reich K, Gooderham M, Thaçi D, Crowley JJ, Ryan C, Krueger JG, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet 2019; 394: 576-586. DOI:

Warren RB, Blauvelt A, Poulin Y, Beeck S, Kelly M, Wu, T, et al. Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): results from a phase III, randomized, open-label, efficacy-assessor-blinded clinical trial. Br J Dermatol 2021; 184: 50-59. DOI:

Blauvelt A, Leonardi CL, Gooderham M, Papp KA, Philipp S, Wu JJ, et al. Efficacy and safety of continuous risankizumab therapy vs treatment withdrawal in patients with moderate to severe plaque psoriasis: a phase 3 randomized clinical trial. JAMA Dermatol 2020; 156: 649-658. DOI:

Hansel K, Zangrilli A, Bianchi L, Peris K, Chiricozzi A, Offidani A, et al. A multicenter study on effectiveness and safety of risankizumab in psoriasis: an Italian 16-week real-life experience during the COVID-19 pandemic. J Eur Acad Dermatol Venereol 2021; 35: e169-e170. DOI:

European Medicines Agency. Skyrizi (risankizumab): summary of product characteristics. 2019 [cited 2020 Nov 15]. Available from:

Fredriksson T, Pettersson U. Severe psoriasis-oral therapy with a new retinoid. Dermatologica 1978; 157: 238-244. DOI:

Yiu ZZN, Mason KJ, Hampton PJ, Reynolds NJ, Smith CH, Lunt M, et al. Randomized trial replication using observational data for comparative effectiveness of secukinumab and ustekinumab in psoriasis: a study from the British Association of Dermatologists Biologics and Immunomodulators Register. JAMA Dermatol 2021; 157: 66-73. DOI:

Reddy V, Yang EJ, Myers B, Liao W. Clinical evaluation of risankizumab-rzaa in the treatment of plaque psoriasis. J Inflamm Res 2020; 13: 53-60. DOI:

Norlin JM, Nilsson K, Persson U, Schmitt-Egenolf M. Complete skin clearance and Psoriasis Area and Severity Index response rates in clinical practice: predictors, health-related quality of life improvements and implications for treatment goals. Br J Dermatol 2020; 182: 965-973. DOI:

Megna M, Fabbrocini G, Ruggiero A, Cinelli E. Efficacy and safety of risankizumab in psoriasis patients who failed anti-IL-17, anti-12/23 and/or anti IL-23: preliminary data of a real-life 16-week retrospective study. Dermatol Ther 2020; 33: e14144. DOI:

Bonifati C, Morrone A, Cristaudo A, Graceffa D. Effectiveness of anti-interleukin 23 biologic drugs in psoriasis patients who failed anti-interleukin 17 regimens. A real-life experience. Dermatol Ther 2021; 34: 21-24. DOI:

Megna M, Cinelli E, Gallo L, Camela E, Ruggiero A, Fabbrocini G. Risankizumab in real life: preliminary results of efficacy and safety in psoriasis during a 16-week period. Arch Dermatol Res 2021 Feb 20 [Epub ahead of print]. DOI:

Crowley JJ, Warren RB, Cather JC. Safety of selective IL-23p19 inhibitors for the treatment of psoriasis. J Eur Acad Dermatol Venereol 2019; 33: 1676-1684. DOI:

Gisondi P, Facheris P, Dapavo P, Conti A, Naldi L, Cazzaniga S, et al. The impact of the COVID-19 pandemic on patients with chronic plaque psoriasis being treated with biological therapy: the Northern Italy experience. Br J Dermatol 2020; 183: 373-374. DOI:




How to Cite

Borroni, R. G., Malagoli, P., Gargiulo , L., Valenti, M., Pavia, G., Facheris, P., Morenghi, E., di Corteranzo, I. G., Narcisi, A., Ortoncelli, M., Dapavo, P., & Costanzo, A. (2021). Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study. Acta Dermato-Venereologica, 101(11), adv00605.