Risankizumab Showed Efficacious and Favorable Safety Profile for Psoriatic Arthritis

According to a study published in Rheumatology and Therapy, the risankizumab clinical regimen showed linear and time-independent pharmacokinetics and achieved efficacy and a favorable safety profile for patients with acute psoriatic arthritis (PsA).

Researchers conducted population pharmacokinetic and exposure-response analyses using the data from the phase 2 and phase 3 studies on risankizumab in patients with active PsA. Data from a total of 1527 participants were included in the pharmacokinetic analyses. Risankizumab 150 mg was administered subcutaneously at weeks 0, 4, and every 12 weeks thereafter and compared with placebo. Nonlinear mixed-effects modeling was used to analyze pharmacokinetics. Data from 1407 patients with PsA were included in the exposure-response analyses, and graphical analyses were used to evaluate efficacy and safety exposure-response relationships. Further assessments of efficacy exposure-response relationships were conducted using logistic regression. 

Steady-state systemic concentrations of risankizumab were achieved by week 16 under the clinical regimen. The systemic clearance was estimated to be ~ 0.31 L/day, the steady-state volume of distribution was 11.1 L, and the terminal phase elimination half-life was 26.3 days for a typical patient with PsA weighing 90 kg. Subcutaneous bioavailability was 83.5%. The covariates evaluated in the pharmacokinetic analyses failed to result in a clinically relevant impact on risankizumab exposure.

“Risankizumab exhibited linear and time-independent pharmacokinetics in patients with PsA and was comparable to patients with plaque psoriasis,” concluded the study authors. “Efficacy and safety exposure-response analyses support that the clinical regimen achieved robust efficacy with a favorable safety profile for patients with active PsA,” they added.

Reference
Thakre N, D’Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population pharmacokinetics and exposure-response analyses for risankizumab in patients with active psoriatic arthritis. Rheumatol Ther. 2022;10.1007/s40744-022-00495-0. doi:10.1007/s40744-022-00495-0