In patients with moderate to severe genital psoriasis, subcutaneous ixekizumab administered every 2 weeks is associated with rapid and sustained improvements in lesional signs, reductions in genital pain, and improvements in sexual health, according to study results published in the Journal of the European Academy of Dermatology and Venereology.
The study was a post-hoc analysis of the IXORA-Q study (NCT02718898) and included 149 adult patients with moderate to severe genital psoriasis, static Physician’s Global Assessment of Genitalia (sPGA-G) score of ≥3, and body surface area (BSA) involvement of ≥1%. In this subgroup analysis of the IXORA-Q study, researchers focused on patients who presented with or without erosions, fissures, and/or ulcers in genital lesions. Patients were randomly assigned to receive either 80 mg subcutaneous ixekizumab every 2 weeks (n=75) or placebo (n=74). Both treatments were administered during a blinded 12-week treatment period. Disease severity, patient-reported genital pain and itch, and sexual health outcomes were assessed.
Genital erosions, fissures, and/or ulcers independent of overall BSA involvement (<10% or ≥10%) were associated with higher scores for disease severity (sPGA-G) and pain but not sexual health (GenPs-SFQ) in the 38% of patients (n=57) who presented with these symptoms at baseline.
At weeks 1 and 12, the percentage of patients with complete resolution of these symptoms after treatment with ixekizumab was 62% and 83%, respectively. With placebo, 25% of patients at week 1 and 21% of patients by week 12 had resolution of symptoms. Patients treated with Ixekizumab also reported greater improvements in pain, itch, disease severity, and sexual health during the course of the 12-week treatment period.
Changes in disease severity in patients with genital erosions, fissures, and/or ulcers were significantly greater at 12 weeks with ixekizumab vs placebo (least square [LS] mean difference, −1.4; 95% CI, −1.9 to −1.0; P <.001). At 12 weeks, patients with these symptoms who were treated with ixekizumab had a significantly greater change in the modified Genital Psoriasis Area and Severity Index (LS mean difference, −15.4; 95% CI, −21.6 to −9.3; P <.001).
Study limitations include the small sample sizes for each group, as well as the short follow-up duration.
The researchers wrote that genital pain was the leading symptom in patients with genital erosions, fissures, and/or ulcers, “highlighting the importance of assessing disease severity and treatment outcomes from both physician and patient perspectives.”
Disclosure: This clinical trial was supported by Eli Lilly and Company. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Merola JF, Ghislain PD, Dauendorffer JN, et al. Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis [published online January 9, 2020]. J Eur Acad Dermatol Venereol. doi:10.1111/jdv.16181