Real-world data confirms safety, efficacy of guselkumab in plaque psoriasis

Guselkumab performed comparably in a real-world study of patients with moderate to severe plaque psoriasis as it had in previous clinical trials, according to study findings.

Dario A. Marletta, MD, of the unit of dermatology at Ca’Granda Foundation and Institute for Research and Care at Maggiore Polyclinic Hospital in Milan, Italy, suggested that while the efficacy of guselkumab (Tremfya, Janssen) has been shown in a clinical trial setting, real-world data are sparse.

“The aim of the real-life experience was to provide information and updates about this therapy, considering a great number of patients in our department are treated with this drug,” Marletta told Healio.

The single-center study included 79 patients (mean age, 51 ± 15 years) with moderate to severe plaque psoriasis. All patients completed at least 28 weeks of treatment, and mean treatment duration was 16.5 ± 7.5 months.

The proportion of participants who reached PASI 90 response at week 28 served as the primary outcome measure. The group also assessed for PASI 50, PASI 75 and PASI 100.

At week 28, 92% of patients reached PASI 50 or higher, 82% reached PASI 75 or higher and 68% reached PASI 90 or higher. Moreover, nearly half of the cohort (44%) reached PASI 100.

Further analysis showed that similar outcomes were reported through week 44. By this time point, 82% of patients reached PASI 50, 74% reached PASI 75, 65% reached PASI 90 and 46% reached PASI 100.

By the end of the study period, the rates ranged from 84% for PASI 50 through 44% for PASI 100, which Marletta called unsurprising given the clinical response from previous trials.

The researchers observed no significant adverse events.

“The clinical implications of this study are that, above all, the safety and tolerance of guselkumab has been demonstrated as a first-line option when starting biologics, especially in biologic-naïve patients,” Marletta concluded.