Health Canada approves Skyrizi to treat Psoriatic Arthritis.
AbbVie announced Health Canada has approved Skyrizi (risankizumab), for the treatment of adult patients with active psoriatic arthritis.
In PsA, Skyrizi can be used alone or in combination with a conventional non-biologic disease-modifying antirheumatic drug (cDMARD) (e.g., methotrexate). This is the second indication for Skyrizi in Canada.
In April 2019, Health Canada approved Skyrizi for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
KEEPsAKE-1 and KEEPsAKE-2 are both Phase III, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of Skyrizi in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated Skyrizi in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated Skyrizi in patients who had an inadequate response or intolerance to biologic therapy and/or DMARD.