| 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. |