Treatment of guselkumab was found to be safe and effective in improving health-related quality-of-life (HRQOL) and skin manifestations of patients with moderate to severe psoriasis in a real-world setting.
Biologic therapy with guselkumab may effectively and safely improve health-related quality of life (HRQOL) and skin manifestations in patients with psoriasis, according to real-world study findings published recently in The Journal of Dermatology.
In addressing the HRQOL implications of psoriasis, the study authors noted that patients are at increased risk of developing comorbidities, such as anxiety and depression, which could further impact their symptom burden. As a result, evaluation of treatments warrants reliable instruments that account for the severity of not only the disease itself, noted the researchers, but also of the psychological distress, disability, and other HRQOL effects associated with the chronic inflammatory skin condition.
Guselkumab, a fully human monoclonal antibody that binds to the p19 subunit of interleukin-23 (IL-23), is approved by the FDA for the treatment of psoriasis, with long-term efficacy and safety having been demonstrated in prior randomized controlled trials (RCTs).
However, because patients treated in RCTs often receive fewer previous therapies and have fewer comorbidities than patients in the real-world setting, the study authors sought to further evaluate the efficacy and safety of guselkumab via real-world data derived from the prospective, multicenter PERSIST study.
“PERSIST is a noninterventional study investigating the effect of guselkumab and ustekinumab treatment on HRQOL, and their long-term efficacy and safety in patients with moderate to severe psoriasis, in routine clinical practice,” explained the study authors.
Focusing on enrolled patients with moderate to severe plaque psoriasis treated with guselkumab (N = 303; mean [SD] age, 49.7 [13.8]; mean disease duration, 21.0 [14.0] years), the primary end point evaluated the proportion of participants with a Dermatology Life Quality Index (DLQI) score <1 at week 28.
Secondary end points included Psoriasis Symptoms and Signs Diary (PSSD), Psoriasis Area Severity Index (PASI), and body area–specific Physician's Global Assessment outcomes at week 28.
At baseline, the mean DLQI score was 13.7; mean symptom and sign scores in the PSSD were reported as 51.9 and 60.8, respectively; and PASI and body surface area scores were 16.4 and 27.5, respectively.
After 28 weeks, a mean DLQI score decrease of 2.8 was observed in patients treated with guselkumab, in which 56.8% (n = 150) achieved the primary end point (DLQI ≤1). Furthermore, significant improvements were observed across secondary outcomes at the 28-week mark:
“Guselkumab is efficacious and well tolerated, even for patients who have received several previous biologic therapies or have psoriasis in difficult-to-treat areas,” concluded the study authors. “While the data presented here provide important insights, longer-term data from PERSIST and other sources will expand understanding of the real-world performance profile of guselkumab for treatment of psoriasis.”
Gerdes S, Bräu B, Hoffman M, et al. Real-world effectiveness of guselkumab in patients with psoriasis: Health-related quality of life and efficacy data from the noninterventional, prospective, German multicenter PERSIST trial. J Dermatol. Published online September 12, 2021. doi:10.1111/1346-8138.16128