Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study

Ogdie, A; Merola, JF; Mease, PJ; Ritchlin, CT; Scher, JU; Lafferty, KP; Chan, D; Chakravarty, SD; Langholff, W; Wang, Y; Shao, J; Krol, Y; Gottlieb, AB

doi:10.1002/art.70092

Spondyloarthritis & psoriatic arthritis

Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study

Arthritis RheumatolPublished 16 Apr 2026Randomised controlled trial

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Authors' conclusion

Comparable efficacy was observed with both guselkumab regimens in participants with active PsA and inadequate response to one prior TNF inhibitor; safety findings were consistent with the known profile of guselkumab in patients with psoriatic disease.

Study context

Population: Adults with active psoriatic arthritis (PsA) (≥3 swollen joints; ≥3 tender joints; CRP ≥ 0.3 mg/dL) and inadequate response to one prior TNFirandomized, analysed
Participants: 451 adults

Comparison: Guselkumab 100 mg Q4W or Q8W vs placebo
Q4Wn = 150
Q8Wn = 151
Placebon = 150reference
Primary endpoint: ACR20
Follow-up: Week 24

Methodological detailsphase 3b, multicentre, double-blind, placebo-controlled, intention-to-treat

Phase 3b
Multicentre
Double-blind
Placebo-controlled
Intention-to-treat

Primary result

As reported in the abstract

Q4W58.6%

Q8W62.2%

Placebo34.8%

Q4W vs Placebo: P < 0.001 · Q8W vs Placebo: P < 0.001

Secondary outcomes

ACR50 · week 24

Q4W31.4%

Q8W32.1%

Placebo12.2%

ACR70 · week 24

Q4W17.5%

Q8W17.3%

Placebo2.0%

IGA 0/1 response · week 24

Q4W50.0%

Q8W57.3%

Placebo17.4%

PASI90 · week 24

Q4W49.4%

Q8W45.5%

Placebo12.0%

MDA · week 24

Q4W18.8%

Q8W23.9%

Placebo5.4%

ACR50 — Both regimens vs placebo: P < 0.001
ACR70 — Both regimens vs placebo: P < 0.001
IGA 0/1 response — Both regimens vs placebo: P < 0.001
Psoriasis Area and Severity Index (PASI90) — Both regimens vs placebo: P < 0.001
Minimal disease activity (MDA) — Both regimens vs placebo: P < 0.001

Death

One death (MI): 1

Safety

≥1 adverse event · through week 24

Q4W46.7%

Q8W53.6%

Placebo48.3%

Original publication

Efficacy and Safety of Guselkumab in Participants With Active Psoriatic Arthritis After Inadequate Response to One Prior Tumor Necrosis Factor Inhibitor: Week‐24 Results of a Phase 3, Randomized, Placebo‐Controlled Study. Arthritis Rheumatol. Published 16 April 2026. doi:10.1002/art.70092

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