Ustekinumab and Guselkumab Effective for Plaque Psoriasis at 2 Years

Ustekinumab and guselkumab were effective and improved quality of life (QOL) for up to 2 years in patients with moderate to severe plaque psoriasis, according to study results published in the Journal of the European Academy of Dermatology and Venereology.

Researchers reported long-term results (week 104) from the prospective, noninterventional PERSIST study, which was conducted at 55 sites in Germany. Participants 18 years of age and older who had been diagnosed with moderate to severe plaque psoriasis were enrolled and treated with ustekinumab or guselkumab for 2 years.

In the current analysis, efficacy and QOL outcomes at week 104 were evaluated to determine the proportion of patients who had achieved an absolute Psoriasis Area and Severity Index (PASI) score of 5 or lower, 3 or lower, and 1 or 0; and the proportion who had achieved a 75% PASI score (PASI 75), a 90% PASI score (PASI 90), or 100% (PASI 100) improvement in their PASI score vs baseline, among other measures. The primary study endpoint, which was previously reported, was the proportion of patients with a Dermatology Life Quality Index (DLQI) score of 0 or 1 after 28 weeks of treatment. A propensity score-based method was used in an ad hoc exploratory analysis of outcomes.

There were 313 patients (mean age [SD], 49.0 [13.8] years; 63.3% men) in the ustekinumab group. Patients’ mean (SD) PASI score decreased over time from 15.8 (9.4) at baseline to 2.0 (3.3) at week 104. The proportions of patients with an absolute PASI score of 5 and lower, 3 and lower and, 1 or 0 increased over time. At week 104, 54.6% of patients treated with ustekinumab achieved PASI 90, and 64.4% of patients had a DLQI score of 0 or 1. Treatment-related adverse events (TRAEs) occurred in 20.8% of patients.

In the guselkumab group, data were available for 302 patients (mean age, 49.7 [13.8] years; 63.9% men). Patients’ mean PASI score decreased over time from 15.7 (9.8) at baseline to 2.4 (4.7) at week 104. The proportion of patients with an absolute PASI score of 5 and lower, 3 and lower, and 1 or 0 increased over time. At week 104, 64.7% of patients treated with guselkumab achieved PASI 90, and 63.6% had an overall DLQI score of 0 or 1. In addition, 17.9% of patients had 1 or more TRAEs (which were mostly mild or moderate in severity).

The propensity score matching analysis included a total of 294 patients from the ustekinumab and guselkumab groups. A PASI score of 1 or 0 at week 104 was more common in patients who received guselkumab vs ustekinumab (58.7% vs 49.7%, respectively). PASI 90 response rates at week 104 were 65.6% with guselkumab and 56.0% with ustekinumab. Also at week 104, the proportion of patients with a DLQI score of 0 or 1 had increased in both cohorts (ustekinumab, 64.4%; guselkumab, 64.6%).

In comparing biologic-naïve vs biologic-experienced patients, the researchers found that PASI 90 was achieved in a greater proportion of biologic-naïve patients (77.1% vs 53.4%, respectively). Additionally, among biologic-naïve patients, a greater proportion who received guselkumab had a DLQI score of 0 or 1 at week 104 compared with patients treated with ustekinumab (76.6% vs 65.9%, respectively). TRAEs occurred in 20.7% of ustekinumab-treated and 18.0% of guselkumab-treated patients.

A potential limitation of the propensity-matching analysis is that patients received their respective treatments at different time periods, and differences in patient or disease characteristics may remain despite use of propensity score matching to control for confounding variables.

“In conclusion, data from the real-world PERSIST study demonstrate improvements in physician-assessed and patient-reported outcomes with ustekinumab and guselkumab in patients with psoriasis that are sustained for up to 2 years, with no new safety signals identified,” the researchers wrote. They added that because the greatest improvements occurred in biologic-naïve patients treated with guselkumab, early intervention with the drug offers great value.

Disclosure: This study was funded by Janssen-Cilag GmbH (Germany). Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

This article originally appeared on Dermatology Advisor