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. 2019 Nov 22;59(3):311–326. doi: 10.1007/s40262-019-00842-5
Risankizumab exhibits typical immunoglobulin (Ig) G1 monoclonal antibody pharmacokinetic characteristics with bi-exponential disposition, long elimination half-life (approximately 28 days), and linear pharmacokinetics when administered intravenously (0.01 mg/kg–1200 mg) or subcutaneously (0.25 mg/kg–300 mg).
Bodyweight, high titers of antidrug antibodies, baseline serum albumin, baseline high-sensitivity C-reactive protein, and baseline serum creatinine were statistically correlated with risankizumab clearance in population pharmacokinetic analyses; however, exposure–response analyses demonstrated that these covariates had no clinically meaningful impact on risankizumab efficacy in psoriasis patients with the clinical dosing regimen of 150 mg administered at weeks 0 and 4, and every 12 weeks thereafter.
The risankizumab clinical dosing regimen maximized efficacy as assessed by the Psoriasis Area and Severity Index (PASI) 90, PASI 100, and static Physicians Global Assessment 0/1 responses, with no apparent correlation between exposure and safety in patients with plaque psoriasis.
A therapeutic protein drug interaction study and population pharmacokinetic analyses confirmed the expected lack of drug interaction potential for risankizumab as a perpetrator or a victim.