Guselkumab Well Tolerated in PsA Regardless of Prior TNF Inhibitor Use

Treatment with guselkumab was found to be well tolerated in patients with moderate to severe psoriatic arthritis (PsA), regardless of tumor necrosis factor inhibitor (TNFi) use, according to the results of a pooled analysis published in The Journal of Rheumatology. 

The researchers evaluated pooled safety results through the end of phase 2/3 studies of guselkumab for up to 2 years in TNFi-nave and TNFi-experienced patients with PsA.

Data were pooled from 4 studies including phase 2 (ClinicalTrials.gov Identifier: NCT02319759); DISCOVER-1 (ClinicalTrials.gov Identifier: NCT03162796); DISCOVER-2 (ClinicalTrials.gov Identifier: NCT03158285); and COSMOS (ClinicalTrials.gov Identifier: NCT03796858).

Patients with active PsA were randomly assigned to receive guselkumab 100 mg every 4 or 8 weeks (combined guselkumab group) or placebo with crossover to guselkumab every 4 or 8 weeks at week 24.

Time-adjusted adverse event (AE) rates (ie, events per 100 patient-years [PY]) and clinical laboratory findings were evaluated during the placebo-controlled period and through the end of the analyses.

A total of 1554 patients were included in the study, 373 of whom received guselkumab every 4 weeks, 664 received guselkumab every 8 weeks, and 517 received placebo. Overall, 1508 individuals received at least 1 administration of guselkumab and were followed up with for a median of 1.2 years (2125 PY).

Treatment was completed by 89.06% (n=1384/1554) of patients.

Rates of AEs through week 24 were 220.8 per 100 PY among the TNFi-naive participants and 251.6 per 100 PY among the TNFi-experienced participants in the combined guselkumab group, and 196.1 per 100 PY and 303.0 per 100 PY, respectively, in the placebo group.

Among patients who received treatment with guselkumab, low AE rates were maintained during long-term assessment in both TNFi-naive (139.69 per 100 PY) and TNFi-experienced patients (174.0 per 100 PY).

Rates per 100 PY that led to treatment discontinuation, serious AEs, and other AEs of interest, as well as occurrence of elevated hepatic transaminase levels and decreased neutrophil counts, were consistent between those who received treatment with guselkumab and those who received placebo through week 24, regardless of prior TNFi use.

Study limitations included the lack of a comparator after the first 24 weeks; the difference in the follow-up periods between the DISCOVER and COSMOS studies; and the small number of patients who tested positive for antibodies to guselkumab during the immunogenicity analyses.

The study authors concluded, “Together with the robust efficacy data, these results further support the long-term use of guselkumab as an initial biologic therapy or in those who have failed or were intolerant to TNFi treatment.”

Disclosure: Data presented in this research was supported by Janssen Research and Development, LLC. Some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.