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Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study
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Inhibition of structural damage progression with the selective interleukin-23 inhibitor guselkumab in participants with active PsA: results through week 24 of the phase 3b, randomised, double-blind, placebo-controlled APEX study

Philip J. Mease, Christopher T. Ritchlin, Laura C. Coates, Alexa P. Kollmeier, Bei Zhou, Yusang Jiang, Karen Bensley, Koeun Im, Rattandeep Batra, Soumya D. Chakravarty, …
Annals of the rheumatic diseases, v 84(12), pp 1983-1994
01 Dec 2025
DOI: https://doi.org/10.1016/j.ard.2025.08.006
PMID: 40962616
Featured in Collection :   UN Sustainable Development Goals @ Drexel
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https://doi.org/10.1016/j.ard.2025.08.006View
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Abstract

Life Sciences & Biomedicine Science & Technology Rheumatology
Objectives: The APEX study evaluated the effects of guselkumab, a fully human, dual-acting monoclonal antibody able to bind CD64 and selectively inhibit the interleukin (IL)-23p19 subunit, on clinical and radiographic outcomes in active psoriatic arthritis (PsA). Methods: APEX (ongoing, phase 3b, double-blind, placebo-controlled) randomised (5:7:7) biologic-na & iuml;ve adults with active PsA (>= 3 tender, >= 3 swollen joints; C-reactive protein >= 0.3 mg/dL; >= 2 erosive joints) to subcutaneous guselkumab 100 mg every 4 weeks (Q4W); guselkumab 100 mg at week 0, week 4, then every 8 weeks (Q8W); or placebo every 4 weeks. Primary (proportion of participants achieving >= 20% improvement in American College of Rheumatology response criteria [ACR20]) and major secondary (total PsA-modified van der Heijde-Sharp [vdH-S] score least squares mean [LSM] change from baseline) endpoints at week 24 were multiplicity-controlled for comparing each guselkumab group versus placebo. Results: Among 1020 participants (Q4W: 273; Q8W: 371; placebo: 376), significantly greater proportions of participants receiving guselkumab Q4W (66.6%) and Q8W (68.3%) versus placebo (47.0%) achieved ACR20 at week 24 (both P < 0.001). Baseline mean total vdH-S scores were 26.7 to 27.7 across groups; guselkumab Q4W- and Q8W-treated participants exhibited significantly lower rates of radiographic progression versus placebo at week 24 (total vdH-S score LSM change: 0.55 and 0.54 vs 1.35; P = 0.002 and P < 0.001, respectively). Through week 24, 38.2%, 42.5%, and 37.3% of participants receiving guselkumab Q4W, Q8W, and placebo, respectively, had >= 1 adverse event, with no new safety signals. Conclusions: Guselkumab, a fully human monoclonal antibody able to bind CD64 and simultaneously inhibit the IL-23p19 subunit, provided significantly higher rates of clinical improvement and significant inhibition of structural damage progression versus placebo, with no new safety signals, at week 24 in biologic-na & iuml;ve participants with active and erosive PsA.

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Rheumatology
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