Novel IL-23 blocker risankizumab highly effective and tolerable in psoriasis

In the phase 3 IMMerge trial, risankizumab showed non-inferiority to secukinumab after 16 weeks and superiority in all assessed efficacy endpoints at week 52 in patients with moderate-to-severe plaque psoriasis [1,2].

“Although we have many efficacious drugs in psoriasis now, it is important to know which drug is used when, and of course, which drug is better than others,” said Prof. Richard Warren (University of Manchester, UK). Thus, head-to head studies are important. In this current head-to-head trial, the IL-23 blocker risankizumab was compared with the IL-17 blocker secukinumab in adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Participants (n=327) were randomised to receive either 150 mg risankizumab at weeks 0, 4, and every 12 weeks thereafter or 300 mg secukinumab weekly from week 0 to 4, and every 4 weeks thereafter. Primary outcome measures were the percentage of participants with a 90% reduction from baseline in Psoriasis Area and Severity Index (PASI 90) at week 16 (non-inferiority margin of 12%) and week 52. Secondary outcomes were the percentage of participants with a 75% and 100% reduction from baseline PASI (PASI 75 and 100, respectively), as well as the percentage of participants with Static Physician Global Assessment (sPGA) score of clear or almost clear skin at week 52.

At week 16, 74% of patients treated with risankizumab achieved PASI 90 compared with 66% of patients treated with secukinumab. The adjusted difference (CI 95%) was 8.2% (-2.2 to 18.6); thus, non-inferiority was met. The difference was even more pronounced after 52 weeks: 87% of patients treated with risankizumab compared with 57% in the secukinumab group achieved a PASI 90 response (P<0.001) (see Figure). In addition, all secondary outcomes demonstrated the superiority of risankizumab (P<0.001).

Figure: IMMerge primary efficacy results over a year: PASI 90 (NRI) [1]



PASI, Psoriasis Area and Severity Index; NRI, non-responder imputation.
* P<0.001 nominal
**P<0.01 multiplicity controlled

Side effects were reported by 71% in both groups, but no new safety signals were detected. Two patients in the risankizumab group and 8 secukinumab patients discontinued the study drug because of an adverse event. Serious adverse events were reported by 9 patients in the risankizumab and 6 patients in the secukinumab arm.

Prof. Warren concluded that the IL-23 blocker risankizumab demonstrated non-inferiority to secukinumab after 16 weeks and superiority after 52 weeks.

1. Warren RB, et al. Late-breaking abstract, AAD Virtual Meeting Experience, 12-14 June 2020.
2. Warren RB, et al. Br. J. Dermatol. 28 June 2020. DOI:10.1111/bjd.19341.

 



Posted on 6 August 20205 August 2021