Background: Guselkumab, a fully human, dual-acting[1] interleukin-23p19-subunit inhibitor, has demonstrated multidomain efficacy in patients with active psoriatic arthritis (PsA).[2]

Objectives: Assess effectiveness and on-label treatment persistence with guselkumab at 12 months (12M) in patients with active PsA.

Methods: This analysis included PPD™ CorEvitas™ PsA/Spondyloarthritis Registry participants who initiated guselkumab post-FDA approval (7/13/2020) and maintained persistence with the FDA-approved dosing regimen (100mg; Week 0, 4, and Q8W) ² through 12M (by 7/31/2025; ‘On-Label Persisters’). Multiplicity-controlled outcomes tested in hierarchical order were mean (95%CI) changes from therapy initiation (baseline) to 12M in: clinical Disease Activity Index for PsA (cDAPSA; primary endpoint); Physician Global Assessment of arthritis+psoriasis (PsO) (PGA, 0-100), patient-reported pain (Pt Pain; 0-100), and percent body surface area with PsO (%BSA) (major secondary endpoints).

Results: Of 160 on-label guselkumab initiators with eligible baseline and 12M visits, 90 (56%) were On-Label Persisters and included in effectiveness analyses. At baseline, mean (SD) duration since PsA diagnosis=7.0 (7.6) years, cDAPSA=21.5 (18.2), PGA=38.4 (23.8), and Pt Pain=55.7 (23.8); 97% had current or history of PsO (mean %BSA=7.1) and 60% had ≥2 prior biologic/targeted synthetic DMARDs (Table 1). Statistically significant mean improvements from baseline to 12M were observed in the primary and all major secondary endpoints: cDAPSA (-8.8), PGA (-20.3), Pt Pain (-12.2), and %BSA (-5.9) (all p<0.001; Figure 1).

Conclusions: In this real-world population of patients with longstanding, active, and largely treatment-refractory PsA, significant improvements in clinical measures of joint and skin disease activity and patient reported outcomes were observed at 12M with persistent on-label guselkumab therapy. More than half of on-label guselkumab initiators remained persistent through 12M.

REFERENCES: [1] Sachen KL. Front Immunol . 2025;16:1532852.

[2] Tremyfa: Package insert. Horsham, PA: Janssen Biotech, Inc.; 2025.

Acknowledgments: NIL.

Disclosure of Interests: Philip J. Mease Speakers bureau: AbbVie, Amgen, Eli Lilly, Johnson & Johnson, Novartis, and UCB, Consultant: AbbVie, Amgen, Bristol Myers Squibb, Century, Cullinan, Eli Lilly, Inmagene, Johnson & Johnson, Merck, Moonlake, Novartis, Pfizer, Spyre, SUN Pharma, Takeda, and UCB, Grant/research support: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Moonlake, Novartis, Sana, Takeda, and UCB, Alexis Ogdie Consultant: AbbVie, Amgen, Bristol Myers Squibb, CorEvitas, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Oruka, Pfizer, Spyre, Takeda, and UCB; Advisory board fees: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer, and UCB, Grant/research support: AbbVie, Pfizer, and Novartis (all to University of Pennsylvania) and Amgen (to Forward/NDB); other funding from NIAMS, Rheumatology Research Foundation, National Psoriasis Foundation, University of Pennsylvania, John Tesser Speakers bureau: AbbVie, Aqtual, Argenix, AstraZeneca, Bendcare, Biogen, GSK, Johnson & Johnson, Pfizer, and Sanofi/Genzyme, Consultant: AbbVie, AstraZeneca, GSK, Immpact Bio, Johnson & Johnson, Novartis, Sanofi-Genzyme, Setpoint, and UCB, Timothy Fitzgerald Shareholder: Owns stock or stock options in Johnson & Johnson, Employee: Johnson & Johnson, Elizabeth Adamson Shareholder: Owns stock or stock options in Johnson & Johnson, Employee: Johnson & Johnson, Soumya D. Chakravarty Shareholder: Owns stock or stock options in Johnson & Johnson, Employee: Johnson & Johnson, Robert R. McLean Shareholder: Thermo Fisher Scientific, Employee: PPD™ CorEvitas™ Clinical Registries, Thermo Fisher Scientific, Taylor Blachley Shareholder: Thermo Fisher Scientific, Employee: PPD™ CorEvitas™ Clinical Registries, Thermo Fisher Scientific, Melissa Eliot Employee: PPD™ CorEvitas™ Clinical Registries, Thermo Fisher Scientific, Skyler S. Peterson Employee: PPD™ CorEvitas™ Clinical Registries, Thermo Fisher Scientific, Aaron Broadwell Speakers bureau: AbbVie, Amgen, Eli Lilly, Horizon, Johnson & Johnson, Mallinckrodt, Novartis, Pfizer, Radius, Sanofi/Regeneron, and UCB, Consultant: AbbVie, Amgen, Aurinia, Celgene, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, and Sandoz, Kurt Oelke Speakers bureau: AbbVie, AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, and UCB, Arthur Kavanaugh Consultant: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Johnson & Johnson, Moonlake, Novartis, Pfizer, and UCB, Joseph F. Merola Consultant: AbbVie, Amgen, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Galderma, Johnson & Johnson, Moonlake, Novartis, Oruka, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB.