A recent analysis has shown that the long-term use of guselkumab (TREMFYA) for treating psoriasis and psoriatic arthritis (PsA) is associated with a consistent safety profile comparable to placebo outcomes observed in previous clinical trials. The analysis assessed previously published clinical trial safety data for the biologic therapy and found that there were minimal to no instances of gastric disease development or treatment-related infections among the 2000-plus treated patients. The findings, presented at the Congress of Clinical Rheumatology (CCR) East 2023 Annual Meeting in Destin, FL, are believed to be the most comprehensive analysis of guselkumab’s safety outcomes to date. The investigators, led by Bruce Strober, MD, Ph.D., clinical professor of dermatology at Yale University School of Medicine and dermatologist with Central Connecticut Dermatology Research, aimed to provide an extensive safety profile of guselkumab’s use in treating psoriatic disease by pooling available phase 2 and 3 study data. Guselkumab, an interleukin-23 (IL-23) inhibitor, has been shown in late-stage data to be beneficial and safe for patients with moderate to severe psoriasis and active PsA, according to Strober and colleagues.
The analysis conducted by investigators combined safety data from 11 clinical trials, including 4 trials for PsA (phase 2; DISCOVER-1; DISCOVER-2; COSMOS) and 7 for psoriasis (X-PLORE; VOYAGE 1 and 2; NAGIVATE; ORION; ECLIPSE; and Japanese registration study).
For the psoriasis studies, patients received guselkumab as a 100 mg subcutaneous injection at baseline, week 4, and every 8 weeks thereafter. Patients who initially received placebo were switched to guselkumab every 8 weeks after week 16, except for two studies. In the PsA studies, placebo patients were switched to guselkumab every 4 or 8 weeks at week 24.
Investigators analyzed safety data from the placebo-controlled portion of the trials and also evaluated the data for up to 5 years in psoriasis patients and up to 2 years in PsA patients. The analysis focused on the incidence rates of key safety events, with adjustments made for the duration of follow-up and events per 100 patient years.
Strober and his team monitored 4,399 patients, treating them with guselkumab for psoriasis or psoriatic arthritis (PSA). They recorded a total of 10,787 patient-years of follow-up, of which 8,662 was from psoriasis patients and 2,125 were from PsA patients. The researchers found 281 adverse events per 100 patient-years among guselkumab-treated patients, while patients on placebo had 272 per 100 patient-years during the placebo-controlled period. Fewer serious adverse events occurred among guselkumab-treated patients (5.6) compared to those treated with placebo (7.8). Rates of serious infections, malignancy, and major adverse cardiovascular events were similar to, if not lower than, placebo-treated patients. The analysis also showed that guselkumab was consistently safe throughout the long-term follow-up period.