Anti-interleukin (IL)-23 monoclonal antibody risankizumab was not inferior to anti-IL-17A monoclonal antibody ixekizumab in the treatment of severe genital psoriasis in regard to efficacy and safety, according to findings from a real-world analysis published in the Journal of the European Academy of Dermatology and Venereology.
The real-world prospective cohort included patients with moderate to severe genital psoriasis who attended an outpatient dermatology clinic in Greece. There was a wash-out period of 4 to 16 weeks for systemic treatment, more than 3 years for acitretin, and 2 or more weeks for topical treatments Patients were naïve to biologic agents but were eligible for biologic disease-modifying antirheumatic drugs.
Through a stratified randomization process, patients were assigned to either risankizumab (n=20; mean age, 53.1±21.3 years) or ixekizumab (n=16; mean age, 56.2 ±20.8 years) at standard dosing schemes. Patients were followed for up to 6 months.
Investigators assessed disease severity, clinical symptoms, and quality of life (QoL) at baseline and 4, 16, and 24 weeks of treatment. Disease severity was assessed with the Static Physicians Global Assessment for Genitalia (sPGA-G), clinical symptoms were assessed with the Psoriasis Area and Severity Index (PASI) score and Itch Numerical- Rating-Score (Itch-NRS), and QoL was assessed with the Dermatology-Life-Quality-Index (DLQI).
The mean duration of psoriasis was numerically lower in the risankizumab group. Treatment with both biologic agents was associated with similar yet significant improvements in sPGA as well as all severity scores through the follow-up period. That is, criteria for almost clear or clear genital skin (sPGA-G 0/1) were achieved by a similar percentage of patients assigned to ixekizumab vs risankizumab at week 16 (68.8% vs 70.0%, respectively) and week 24 (93.8% vs 95.0%) (P >.05).
From baseline to week 24, the mean percentage reductions in the ixekizumab and risankizumab groups were 89.8% and 93.1% for sPGA-G, 93.5% and 95.2% for PASI, 96.7% and 92.9% for Itch-NRS, and 92.1% and 91.8% for DLQI, respectively (P >.05). In the risankizumab arm, the mean decrease in sPGA-G fell from 3.8 (±0.7) at baseline to 0.8 (±0.6) at week 16 (P <.05) and up to 0.3 (±0.9) at week 24 (P <.05). In the ixekizumab-treated patients, the mean sPGA-G decreased from 4.1 (±0.9) to 1.1 (±1.0) at baseline to week 16 (P <.05) and up to 0.4 (±0.8) at week 24 (P <.05).
In all, 2 patients in the risankizumab arm had a minor headache (10.0%) and 1 patient in the ixekizumab group reported an upper respiratory tract infection (6.3%). Despite these adverse events, all patients continued with their assigned therapy.
The small sample size, lack of a blinded design, and the short follow-up period represent potential limitations of the study. Given these limitations, the researchers wrote that longer-term “studies and real-life registries are essential to update the safe and effective use of ixekizumab and risankizumab” in severe genital psoriasis.
Sotiriou E, Bakirtzi K, Papadimitriou I, et al. A head-to-head comparison of risankizumab and ixekizumab for genital psoriasis: a real-life, 24-week, prospective study. J Eur Acad Dermatol Venereol. Published online December 19, 2021. doi:10.1111/jdv.17880