SKYRIZI is dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter. At week 24 when the placebo cohort were switched over to SKYRIZI, loading doses were not administered and patients were immediately switched to 12 weekly dosing.
In the two randomized, double-blind, placebo-controlled KEEPsAKE-1 and KEEPsAKE-2 studies, patients had a diagnosis of PsA ≥6 months based on Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of PsA of 4.9 years at baseline, ≥5 tender joints and ≥5 swollen joints, and active plaque psoriasis or nail psoriasis at baseline. 55.9% of subjects had ≥3% body surface area with active plaque psoriasis. 63.4% and 27.9% of subjects had enthesitis and dactylitis, respectively.
In KEEPsAKE-1, all subjects had a previous inadequate response or intolerance to nonbiologic DMARD therapy and were biologic naïve. In KEEPsAKE-2, 53.5% of subjects had a previous inadequate response or intolerance to nonbiologic DMARD therapy and 46.5% of subjects had a previous inadequate response or intolerance to biologic therapy.
In both studies, subjects were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. Both studies include a long-term extension for up to an additional 204 weeks. 59.6% of subjects from both studies were receiving concomitant MTX, 11.6% were receiving concomitant nonbiologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy. SKYRIZI was dosed 150 mg at Week 0, Week 4, and every 12 weeks thereafter.*Dosing of ustekinumab was 90mg for patients weighing over 100kg.
ACR20, ≥20% improvement in American College of Rheumatology score; q12w, every 12 weeks; SC, subcutaneous; SJC, swollen joint count; TJC, tender joint count.