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Persistence, effectiveness and safety of ustekinumab compared to TNF inhibitors in psoriatic arthritis within the Italian PsABio cohort

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20
Collaborator/s: P. Sarzi-Puttini1, G. Ferraccioli2, C. Galeone3


  1. Fondazione Policlinico A Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.
  2. Università della Campania L Vanvitelli, Naples, Italy.
  3. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, and IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
  4. Università della Campania L Vanvitelli, Naples, Italy.
  5. Presidio Ospedaliero San Marco, AOU Policlinico Vittorio Emanuele, Catania, Italy.
  6. Dipartimento di Medicina Sperimentale e Clinica, Università degli Studi di Firenze, Florence, and Unit of Immunology, Rheumatology, Allergy and Rare diseases (UnIRAR), IRCCS San Raffaele Hospital, Milan, Italy.
  7. Dipartimento di Scienze Cliniche Internistiche, Anestesiologiche e Cardiovascolari, Sapienza Università di Roma, Italy.
  8. AOU Città della Salute e della Scienza di Torino, Italy.
  9. Dipartimento PROMISE, Università degli Studi di Palermo, Italy.
  10. Università degli Studi di Bari Aldo Moro, Bari, Italy.
  11. Università di Pisa, Italy.
  12. Università degli Studi di Roma Tor Vergata e Policlinico Tor Vergata, Rome, Italy.
  13. Unità di Reumatologia, Dipartimento di Medicina, Università degli Studi di Verona, Italy.
  14. AOU San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy.
  15. Janssen-Cilag AB, Solna, Sweden.
  16. Janssen Pharmaceutica NV, Beerse, The Netherlands.
  17. Janssen-Cilag BV, Breda, The Netherlands.
  18. Janssen-Cilag SpA, Cologno Monzese, Italy.
  19. Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, and Rheumatology Department, Pitié-Salpêtrière Hospital, AP-HP Sorbonne Université, Paris, France.
  20. Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Austria.

  1. ASST Fatebenefratelli-Sacco, Università degli Studi di Milano, Italy
  2. Fondazione Policlinico A. Gemelli-IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy
  3. Statinfo srl, Briosco (MB), Italy

Italian PsABio study

2023 Vol.41, N°3
PI 0735, PF 0743
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PMID: 36226614 [PubMed]

Received: 09/03/2022
Accepted : 27/06/2022
In Press: 12/10/2022
Published: 23/03/2023


To compare real-world persistence, effectiveness and tolerability of ustekinumab versus TNF inhibitors (TNFi) in psoriatic arthritis (PsA).
One-year data from Italian subjects enrolled in the PsABio study (PsA patients receiving 1st- to 3rd-line treatment with ustekinumab or TNFi) were evaluated. Treatment persistence was analysed using Kaplan-Meier curves; hazard ratios (HR) of stopping treatment, and the corresponding 95% confidence intervals (CI), were computed through Cox regression models. Proportions of patients reaching clinical effectiveness endpoints were analysed using logistic regression, including propensity score (PS) adjustment for imbalanced baseline covariates, and non-response imputation if treatment was stopped/switched.
Among 222 participants with follow-up data (effectiveness set), 101 received ustekinumab and 121 TNFi. In the ustekinumab group, 74.3% continued treatment up to 12±3 months compared to 63.6% in the TNFi group. Ustekinumab showed better persistence than TNFi, overall and in specific subgroups (females, monotherapy without methotrexate, BMI <25 or >30 kg/m2, patients receiving ustekinumab as 2nd-line treatment instead of a second TNFi). Overall, the PS-adjusted HR of treatment discontinuation was 0.46 (95% CI: 0.26–0.82) for ustekinumab vs. TNFi. cDAPSA LDA/remission was achieved in 43.5% of ustekinumab and 43.6% of TNFi-treated patients, while MDA was achieved in 24.2% and 28.0% of patients, respectively. After PS adjustment, odds ratios of clinical effectiveness did not differ significantly. Both treatments showed an acceptable safety profile.
This prospective, real-life study found a better persistence of ustekinumab than TNFi in PsA patients. At 1 year, both treatments showed similar effectiveness.


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