The efficacy and safety of ixekizumab for the treatment of genital psoriasis was supported by results from a study published in Dermatologic Therapy. In a study cohort of patients with moderate to severe genital psoriasis, subcutaneous ixekizumab was found to significantly improve disease severity, clinical symptoms, and quality of life during a 24-week period.
Clinical trials have demonstrated that ixekizumab may improve psoriatic lesions of the genitals, although its real-world effectiveness is unclear. To inform this gap, investigators conducted a real-life trial of patients 18 years of age or older with moderate to severe genital plaque psoriasis that did not improve with conventional systemic treatment agents.
The trial enrolled consecutive patients from a dermatology clinic in Italy from 2018 to 2019. Patients received genital site injections with ixekizumab at the recommended dosing for psoriasis. Efficacy was assessed at baseline and after 4, 16, and 24 weeks of treatment using the Static Physician’s Global Assessment of Genitalia (sPGA-G), the Psoriasis Area and Severity Index (PASI) score, the Itch Numerical-Rating-Score (Itch-NRS), and the Dermatology-Life-Quality-Index (DLQI). Safety events were recorded throughout the trial duration. The Wilcoxon matched-pair rank test was used to evaluate differences between baseline and follow-up visits.
The study cohort comprised 14 patients: (10 men, mean age 48 ± 12 years; BMI, 28.4 ± 4.4). Mean baseline sPGA-G score was 3.5 ± 0.9 out of a possible 5.0, demonstrating severe genital involvement. Mean baseline PASI, Itch-NRS, and DLQI scores were 14.6 ± 8.2, 6.8 ± 3.2, and 15.9 ± 4.1, respectively, each suggesting moderate to severe disease severity. These figures each declined substantially over the treatment course, with the greatest reduction seen at 24 weeks, the researchers noted. At week 24, mean sPGA-G, PASI, Itch-NRS, and DLQI scores had declined to 0.3 ± 0.5, 0.7 ± 1.4, 1.0 ± 1.4, and 0.3 ± 0.5, respectively. Mean percentage reduction of scores from baseline to study conclusion was 91.4% for sPGA-G, 95.2% for PASI, 95.6% for Itch-NRS and 93.7% for DLQI.
Ixekizumab was well-tolerated by patients. Only 1 adverse event was reported: a community-acquired pneumonia infection that resolved with treatment and only required brief treatment interruption. No patients discontinued treatment.
The primary study limitation is its small cohort and short follow-up period; further studies are necessary to illustrate the long-term efficacy of ixekizumab in the broader population affected by genital psoriasis, the researchers wrote.
“Ixekizumab significantly improved disease severity, itch and quality of life with an acceptable safety profile in a real-life setting in adult patients affected by [genital psoriasis],” investigators concluded.
Disclosure: Several study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Calianno G, Esposito M, Fidanza R, Palmieri M, Fargnoli MC. Ixekizumab improves disease severity, clinical symptoms and quality of life in patients with genital psoriasis: a 24-week real-life experience. Dermatol Ther. Published online May 24, 2021. doi: 10.1111/dth.14993