Risankizumab

Risankizumab (trade name Skyrizi) is a humanized monoclonal antibody targeting interleukin 23A (IL-23A). Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie. Risankizumab has been approved in Europe, USA, Canada and Japan for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Risankizumab (trade name Skyrizi) is a humanized monoclonal antibody targeting interleukin 23A (IL-23A). Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie. Risankizumab has been approved in Europe, USA, Canada and Japan for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In a phase I clinical trial, thirty-nine patients received single-dose risankizumab, 18 of which received the drug intravenously, 13 subcutaneously, and eight received the placebo drug. There were several instances that adverse effects occurred but in the same frequency for the placebo and the experimental groups. Four serious adverse events occurred in the risankizumab treated patients, all of which were judged not treatment related. Risankizumab was associated with clinical improvement in individuals treated with the drug, from week 2 and maintained for up to 66 weeks after treatment. At week 12 of treatment, 75%, 90%, and 100% decreases in the Psoriasis Area and Severity Index (PASI) were achieved by 87%, 58%, and 16% of risankizumab treated patients, regardless of dose, respectively, versus individuals receiving placebo. Significant correlation between treatment-associated molecular changes and PASI improvement was observed in the risankizumab treated patients. The efficacy, safety and tolerability was further investigated in a phase III program comprising four clinical trials which compared risankizumab to ustekinumab, adalimumab and placebo in the indication of plaque psoriasis. The results of these trials confirmed the good efficicy and tolerability of risankizumab. A marketing authorization application for risankizumab has been submitted to the US regulatory authority (Food and Drug Administration), the European Medicines Agency (EMA), and other regulatory agencies. Risankizumab was approved by the FDA for treatment of moderate-to-severe plaque psoriasis on 23 April 2019.