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The following is a summary of “Efficacy and safety of guselkumab in patients with active lupus nephritis: results from a Phase 2, randomized, placebo-controlled study,” published in the December 2024 issue of Rheumatology by Anders et al. 

Researchers conducted a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of guselkumab in patients with active lupus nephritis (LN). 

They randomized 60 adults (18–75 years) with active LN (Class III-IV proliferative nephritis and urine protein-to-creatinine ratio [UPCR] ≥1 mg/mg despite standard-of-care therapy) to receive intravenous guselkumab 400 mg or placebo at Weeks 0, 4, and 8, followed by subcutaneous injections of guselkumab 200 mg or placebo every 4 weeks through Week 48. The primary endpoint was a ≥50% decrease in proteinuria from baseline at Week 24, with major secondary endpoints including complete renal response (CRR), sustained reduction in steroid dose (≤10 mg/day prednisone/equivalent) from Weeks 16–24, UPCR <0.5 mg/mg, UPCR <0.75 mg/mg, time to achieving CRR, and time to treatment failure. Safety was assessed through the end of the study. 

The results showed that 33 participants were randomized (placebo, n=16; guselkumab, n=17) after early study termination due to enrollment challenges. At Week 24, 56.3% (9/16) of patients receiving placebo and guselkumab 35.3% (6/17) achieved the primary endpoint. No differences were observed in secondary endpoints. Through end-of-study, 75% of patients receiving placebo and guselkumab 71% reported ≥1 adverse event (AE), most being mild-to-moderate in severity. 

They found that guselkumab did not outperform placebo in reducing proteinuria in active LN. Safety was consistent with its known profile. 

Source: academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/keae647/7914939