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Guselkumab, an interleukin-23 inhibitor, demonstrated sustained improvements in both TNF-naïve and TNF-experienced patients with psoriatic arthritis.
At the 1-year mark, guselkumab 100 mg, delivered either every 4 weeks or every 8 weeks, provided long-term improvements across multiple domains, including in both tumor necrosis factor inhibitor (TNF)-naïve and TNF-experienced patients with psoriatic arthritis (PsA), according to a study published in ACR Open Rheumatology.1
“Guselkumab (Janssen Biotech), a high-affinity, fully human monoclonal antibody targeting the IL-23p19 subunit, demonstrated efficacy with a favorable safety profile in reducing the signs and symptoms of active PsA in 2 phase 3, randomized, placebo-controlled studies, DISCOVER-1 and DISCOVER-2,” Christopher Ritchlin, MD, MPH, University of Rochester Medical Center, and a team of investigators, wrote. “We have now comprehensively assessed the demographic and disease characteristics, disposition, guselkumab efficacy across disease domains, and guselkumab safety in the TNFi-naive and TNFi-experienced cohorts from DISCOVER-1.”
The phase 3, randomized, double-blind, placebo-controlled trial evaluated the safety and efficacy of guselkumab in patients with psoriatic arthritis. Eligible patients had active PsA, as defined by a tender joint count ≥3, swollen joint count ≥3, and C-reactive protein (CRP) level ≥ 0.3 mg/dl, despite standard therapies. Previous research presented at the American College of Rheumatology 2021 Convergence indicated long-term symptom improvement and inhibited radiographic progression in patients with active PsA receiving the drug.2
Patients were randomized to subcutaneous injections of 100 mg of guselkumab at week 0, week 4, and every 8 weeks (Q8W), every 4 weeks (Q4W), or placebo with guselkumab initiation at week 24. End points were ≥20% (ACR20) and ≥50% (ACR50) improvements in American College of Rheumatology (ACR) criteria and minimal disease activity (MDA) components were categorized by prior TNF history.
Of the 381 patients included in the study, 118 patients (31%) had a history of receiving 1 (n=102) or 2 (n=16) TNF. The composite ACR20 response at week 24 and week 52 were comparable in TNF-naïve and TNF-experience patients in the Q4W cohort (76% and 68%, respectively) and Q8W cohort (61% and 58%, respectively). Similar trends in response rates of individual ACR20 and ACR50 criteria improvements and individual MDA components were observed at week 24.
Improvements in the Health Assessment Questionnaire disability index (HAQ DI) were seen in over 50% of patients treated with guselkumab compared with 29% of those receiving placebo. Patients who were TNF-naïve were more likely to achieve physical function and pain endpoints when compared with the TNF-experienced group. However, response rates were maintained or increased through 1 year regardless of TNF history.
At week 60, 62% of TNF-naïve patients and 64% of TNF-experienced patients reported at least 1 adverse event (AE), with 4% and 6% reporting serious AEs, respectively. These results were consistent with the known safety profile of guselkumab for the treatment of PsA and psoriasis.
The TNF-experienced population was limited to 31%, therefore investigators were unable to reliably compare the efficacy and safety of guselkumab with and without concomitant methotrexate in this group. However, the results support previous research performed in patients with inadequate response to 1 or more TNF (TNF-IR).3