IMPACT study: large real-world evaluation of guselkumab in psoriatic arthritis integrating clinical response and treatment persistence
In brief
Guselkumab achieves low disease activity in 59% of PsA patients after 12 months
In a multicentre real-world cohort of 389 psoriatic arthritis patients, median DAPSA fell from 24.2 to 10.5, with 58.6% reaching low disease activity and 14.1% in remission at one year. Skin clearance was complete in 68% and enthesitis/dactylitis resolved in 63% and 95% respectively, while 79% remained on therapy with no new safety signals.
- Journal
- Therapeutic advances in musculoskeletal disease (Q1)
- Published
- 8 September 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Valentino Paci, Roberta Foti, Ilenia Pantano, Antonio Carletto, Eleonora Celletti, Giovanni Francesco Miceli, et al.
- PMID
- 42719485
- DOI
- 10.1177/1759720X261460108
Why clinicians should know about it
- Picked for Dermatology (top studies of the week, 13 September 2026): Large real-world guselkumab PsA outcomes
- Picked for Rheumatology (top studies of the week, 13 September 2026): Real‑world guselkumab PsA effectiveness
Abstract
BACKGROUND: In psoriatic arthritis (PsA), real-world evidence complements randomised controlled trials by evaluating treatment effectiveness in routine care. Guselkumab (GUS), a selective interleukin-23p19 inhibitor, has demonstrated efficacy in phase-III trials, but real-world data remain limited. OBJECTIVES: To assess the real-world effectiveness, treatment persistence and safety of GUS in a large, multicentre PsA cohort. DESIGN: IMPACT (Italian Multicentric PAtient-Centred assessment of Guselkumab Treatment) is a multicentre, observational, longitudinal study including consecutive adult patients with PsA treated with GUS. METHODS: Clinical assessments were conducted at baseline and at 3, 6, 9 and 12 months. Effectiveness outcomes included the change from baseline in Disease Activity in Psoriatic Arthritis (DAPSA), Axial Spondyloarthritis Disease Activity Score (ASDAS) and Psoriasis Area Severity Index (PASI) scores, as well as the resolution of enthesitis and dactylitis, and treatment persistence. Predictors of DAPSA remission and treatment discontinuation were analysed using multivariable Cox regression models. RESULTS: A total of 389 patients were included (245 (63.0%) female; median age 56.0 years), with moderate-to-high baseline disease burden and prevalent prior biologic (b-)/targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) exposure (86.4%). Median DAPSA decreased from 24.2 at baseline to 10.5 at 12 months, with significant improvements from 3 months onward. The proportion of patients achieving DAPSA-low disease activity, or -remission increased progressively, reaching up to 58.6% (187/319) and 14.1% (45/319), respectively, at 12 months. Improvements were observed across multiple disease domains, including skin involvement (PASI-100 in 123/182 (67.6%) at 12 months), enthesitis and dactylitis (12-month resolution in 118/186 (63.4%) and 57/60 (95.0%), respectively) and axial disease (ΔASDAS -1.7 at 12 months). Treatment persistence was 78.7% at 12 months, with discontinuations mainly due to ineffectiveness; age, sex, fibromyalgia, baseline disease activity, prior b/tsDMARD exposure and corticosteroid use were associated with remission and/or discontinuation. Few adverse events were recorded, with no unexpected safety signals. CONCLUSION: In this large real-world cohort, GUS demonstrated sustained effectiveness in several disease domains, favourable treatment persistence and no unexpected safety signals, supporting its use in routine care of complex and b/tsDMARD-experienced PsA patients.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.