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Publications

Journal Article Epublish

PubMed: 42719485 DOI: 10.1177/1759720X261460108

IMPACT study: large real-world evaluation of guselkumab in psoriatic arthritis integrating clinical response and treatment persistence.

Ther Adv Musculoskelet Dis 18:1759720X261460108

Authors: Valentino Paci, Roberta Foti, Ilenia Pantano, Antonio Carletto, Eleonora Celletti, Giovanni Francesco Miceli, Ignazio Cangemi, Giuseppe Lopalco, Simona Montalbano, Maria Sole Chimenti, Andrea Picchianti Diamanti, Umberto Massafra, Emilio Filippucci, Anna Parisi, Pietro Leccese, Anna Panaccione, Ilaria Puca, Giorgio Amato, Sabrina Marrone, Myriam Di Penta, Salvatore Corrao, Eneida Cela, Alessandra Rai, Enrico Tirri, Florenzo Iannone, Fabiola Atzeni, Maurizio Rossini, Francesco Ciccia, Rosario Foti, Gianluca Moroncini, Michele Maria Luchetti Gentiloni

Affiliations

  • Clinica Medica, Department of Internal Medicine, Marche University Hospital and Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona, Italy.
  • Rheumatology Unit, Policlinico San Marco Hospital, Catania, Italy.
  • Rheumatology Section, Department of Precision Medicine, University of Campania Luigi Vanvitelli, Naples, Italy.
  • Rheumatology Unit, University of Verona, Verona, Italy.
  • Department of Medicine and Science of Aging, Medical Clinic, SS. Annunziata Hospital of Chieti, 'G. D'Annunzio' University of Chieti-Pescara, Chieti, Italy.
  • Rheumatology Unit, AOU G. Martino, University of Messina, Messina, Italy.
  • Department of Clinical Medicine, Internal Medicine Unit with Rheumatology, Dermatology, Diabetology and Tertiary Diabetic Foot Health Care, National Relevance and High Specialization Hospital Trust ARNAS Civico Di Cristina Benfratelli, Palermo, Italy.
  • Department of Precision and Regenerative Medicine and Ionian Area (DiMePRe-J), University of Bari 'Aldo Moro', Bari, Italy.
  • Rheumatology Unit, Department of Medicine, Ospedale del Mare, Naples, Italy.
  • Rheumatology, Allergology and Clinical Immunology, Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
  • Department of Clinical and Molecular Medicine, S. Andrea University Hospital, 'Sapienza' University of Rome, Rome, Italy.
  • Rheumatology Service, S. Pietro Fatebenefratelli Hospital, Rome, Italy.
  • Rheumatology Unit, Department of Clinical and Molecular Sciences, 'Carlo Urbani' Hospital, Polytechnic University of Marche, Ancona, Italy.
  • Rheumatology Unit, AORN Cardarelli, Naples, Italy.
  • Rheumatology Department of Basilicata, San Carlo Hospital, Potenza, Italy.
  • Rheumatology, Santa Maria General Hospital, Terni, Italy.
  • Rheumatology Unit, S.G. Moscati Hospital, Avellino, Italy.
  • Clinica Medica, Department of Internal Medicine, Marche University Hospital and Department of Clinical and Molecular Sciences, Marche Polytechnic University, via Tronto 10/A, Ancona 60020, Italy.

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.

MeSH

Arthritis, Psoriatic, Safety, Arthritis, Therapeutics