Real-world Study Identifies Several Predictors of Risankizumab Response in Psoriasis

Risankizumab was associated with high efficacy in a real-world setting for the treatment of patients with moderate-to-severe psoriasis, although several factors were found to negatively impact therapy response. Results were published in Dermatologic Therapy.

As one of the latest biologic treatments approved by the FDA for moderate to severe plaque psoriasis, risankizumab, a humanized immunoglobulin G1 monoclonal antibody that specifically inhibits interleukin (IL)-23 by binding its p19 subunit, has demonstrated high levels of efficacy and safety across different clinical trials.

Findings of the IMMerge study showed risankizumab to be noninferior to secukinumab at week 16 and superior at week 52, with post hoc analyses indicating that these improved benefits were maintained regardless of weight or body mass index (BMI).

“Real-life studies were scarce and with small sample size and short follow-up, due to the novelty of the drug, most of the studies are limited to the 16th week and in the following weeks the sample drops significantly,” noted researchers. “The analysis of possible response factors to treatment with risankizumab is limited in clinical trials and real-life studies to BMI and the use of previous biologic therapy.”

They sought to further assess the effectiveness and safety of risankizumab and possible prognostic factors, including use of previous biological therapies, obese status, the involvement of difficult sites, smoking, and incidence of psoriatic arthritis (PsA) in a real-life setting. Data of adult patients with moderate to severe psoriasis from 2 tertiary centers in Italy (N = 166) who were treated with risankizumab were derived for the retrospective multicenter study.

Efficacy was measured by the proportion of patients achieving a 100%, 90%, or 75% improvement of psoriatic lesions according to the Psoriasis Area Severity Index (PASI) and those reaching PASI less than 3 at weeks 16, 28, 40, and 52.

“Study population was analyzed in subgroups to investigate possible predictors of response to risankizumab since week 40,” added the study authors. “At the time of analysis 165, 103, 30, and 11 patients had completed 16, 28, 40, and 52 weeks of treatment, respectively.”

Compared with baseline, the mean (SD) PASI score was found to decrease from 12.5 (5.1), indicating severe disease, to a mild disease course of 1.9 (2.4) at week 16. Further reductions were observed at 28, 40, and 52 weeks with a mean (SD) PASI score of 1.1 (2), 1.3 (2.7), and 0.5 (0.5), respectively (P = .000). Similar reductions were also observed when considering PASI less than 3, PASI 75, PASI 90, and PASI 100.

Regarding possible prognostic factors, a lower response to risankizumab was observed in patients who reported incidence of previous biologics failure, current and previous smoking, obesity, and joint involvement. Significantly reduced efficacy of risankizumab, measured via mean PASI, was shown in patients with comorbid PsA vs those without at all time-points:

• 2.7 vs 1.7 at 16 weeks (P = .036)
• 1.9 vs 0.4 at 28 weeks (P = .006)
• 4.1 vs 0.5 at 40 weeks (P = .016)

There was no difference observed in response to risankizumab as it pertainted to involvement of difficult-to-treat areas.

“Real-life studies with higher numbers especially at higher time-points and with longer follow-up could better estimate the efficacy of risankizumab in the clinical setting,” concluded researchers. “Proof-of-concept studies are needed to better evaluate the weight of possible prognostic factors in the psoriasis response to risankizumab.”

Reference

Mastorino L, Susca S, Megna M, et al. Risankizumab shows high efficacy and maintainance in improvement of response until week 52. Dermatol Ther. 2022 Feb 14;e15378. doi:10.1111/dth.15378