Risankizumab

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Risankizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
Targetinterleukin 23A
Clinical data
Trade namesSkyrizi
SynonymsBI-655066, ABBV-066
AHFS/Drugs.comskyrizi
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6476H9992N1720O2016S44
Molar mass145.6 kDa g·mol−1

Risankizumab (trade name Skyrizi) is a humanized monoclonal antibody targeting interleukin 23A (IL-23A).[1] 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.

Clinical trials[edit]

Psoriasis[edit]

In a phase I clinical trial, thirty-nine patients received single-dose risankizumab, 18 of which received the drug intravenously, 13 subcutaneously, and 8 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.[2]

The efficacy, safety and tolerability was further investigated in a phase III program comprising 4 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. [3] A marketing authorization application for risankizumab has been submitted to the US regulatory authority FDA, the European Medicines Agency (EMA) and other regulatory agencies.

References[edit]

  1. ^ Singh, Sanjaya (July–August 2015). "Selective targeting of the IL23 pathway: Generation and characterization of a novel high-affinity humanized anti-IL23A antibody". Mabs. 7 (4): 778–791. doi:10.1080/19420862.2015.1032491. PMC 4622456.
  2. ^ Krueger JG, Ferris LK, Menter A, et al. Anti-IL-23A mAb BI 655066 for treatment of moderate-to-severe psoriasis: safety, efficacy, pharmacokinetics, and biomarker results of a single-rising-dose, randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol 2015; 136(1): 116-124.e7
  3. ^ Gordon KB, Strober B, Lebwohl M, 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 Aug 25;392(10148):650-661