Arthritis & rheumatology (Hoboken, N.J.)
October 20, 2026 · via Europe PMC
Sustained Inhibition of Structural Damage Progression and Improvements in Disease Activity With Guselkumab in Biologic-Naïve Participants with Active and Erosive Psoriatic Arthritis: Results Through Week 48 of the Phase 3b Randomized, Double-Blind, Placebo-Controlled APEX Study.
Ritchlin CT, Mease PJ, Coates LC, +9 more, van der Heijde D.
AI summary — for doctors, generated from the abstract only
Guselkumab kept slowing joint damage and sustained clinical responses through week 48 in biologic-naive patients with active, erosive psoriatic arthritis.
What was studied
Phase 3b randomized, double-blind, placebo-controlled APEX trial of 1020 biologic-naive adults, comparing guselkumab every 4 weeks, every 8 weeks, or placebo switching to guselkumab at week 24.
Key findings
- ACR20/50/70 responses were 71-74%, 51-56% and 31-35% with low structural progression (vdH-S change 0.60-0.78).
- PASI90 was reached by 74-80%, minimal disease activity by 36-41%, and 60-64% had meaningful HAQ-DI improvement.
- Placebo patients' progression slowed after switching (0.96 at weeks 0-24 to 0.41 at weeks 24-48), and adverse events remained stable.
Clinical relevance
It supports guselkumab as a durable option that addresses joint damage as well as skin and function in PsA.
Who should care
Limitations
After week 24 the placebo comparison is lost, so week 48 findings are uncontrolled; the abstract does not report long-term safety beyond 48 weeks.
Consider guselkumab for biologic-naive patients with active erosive PsA, particularly those with skin involvement.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
Objective
In APEX, guselkumab, which binds to the IL-23p19 subunit and CD64 on IL-23-producing cells, demonstrated significant joint efficacy and inhibition of structural damage progression in participants with active and erosive PsA through Week (W)24; W48 findings are reported herein.
Methods
The APEX modified full analysis set included 1020 biologic-naïve adults with active PsA (≥3 tender joints; ≥3 swollen joints; CRP ≥0.3mg/dL; ≥2 erosive joints) randomized to guselkumab every (Q)4W (N=273), guselkumab at W0,4 then Q8W (N=371), or placebo followed by guselkumab Q4W beginning at W24 (N=376). Outcomes through W48 included ACR20/50/70 response rates (using multiple/nonresponder imputation); least squares mean (LSM) change in PsA-modified van der Heijde-Sharp score (vdH-S); achievement of clinically meaningful improvement (CMI; ≥0.35-point) in HAQ-DI, ≥90% improvement in Psoriasis Area and Severity Index (PASI90), and minimal disease activity (MDA).
Results
Through W48, 93% (950/1020) of participants completed study intervention. Guselkumab Q4W and Q8W through W48 demonstrated durable ACR20/50/70 response rates (71-74%/51-56%/31-35%), and low rates of structural damage progression (vdH-S LSM change: 0.60-0.78); 60-64% of participants reported HAQ-DI CMI, 74-80% achieved PASI90, 36-41% achieved MDA. Following transition to guselkumab, structural damage progression among placebo-randomized participants diminished (vdH-S LSM change W0-24: 0.96; W24-48: 0.41) and clinical response rates increased through W48. Adverse event rates were consistent with placebo and guselkumab through W24 and stable through W48 of guselkumab.
Conclusion
APEX W48 findings further support guselkumab use for durable and comprehensive treatment of diverse PsA manifestations. Inhibition of cumulative joint damage with guselkumab may optimize outcomes.
DOI
10.1002/art.70380
PMID
42901870
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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