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Comorbidities in the Spondyloarthritis GISEA Cohort: an average treatment effect analysis on patients treated with bDMARDs

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32
Collaborator/s: C. Bazzani1, S. Bellando Randone2, F.P. Cantatore3, M. Congia4, E.G. Favalli5, E. Fusaro6, G. Galoppini7, C. Garoffoni8, C. Garufi9, C. Lomater10, C.M. Montecucco11, C. Salvarani12, C. Siragusano13, G. Striani14, V. Venerito15, E. Visalli16

 

  1. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy.
  2. Cancer Genomics Core-Lab, Istituto Oncologico Veneto IRCCS, Padova, Italy.
  3. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy.
  4. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy.
  5. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy.
  6. Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Italy.
  7. Department of Internal Medicine and Therapeutics, University of Pavia; and Division of Rheumatology, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.
  8. Rheumatology Clinic, Department of Rheumatology and Medical Sciences, ASST G.Pini-CTO, Milan, Italy.
  9. UOC di Reumatologia, AOU e Università di Cagliari, Monserrato, Cagliari, Italy.
  10. Rheumatology Unit, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  11. Department of Medical and Surgical Sciences, University of Foggia, Italy.
  12. Rheumatology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma, Verona, Italy.
  13. Rheumatology, Allergology and Clinical Immunology, University of Rome Tor Vergata, Rome, Italy.
  14. Rheumatology Unit, Policlinico San Marco University Hospital of Catania, Italy.
  15. Rheumatology Unit, Department of Medical, Surgical and Neurosciences, University of Siena, Italy.
  16. Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Italy.
  17. Reumatologia e Immunologia Clinica, ASST- Spedali Riuniti Civili Brescia, Italy.
  18. Reumatologia, Dipartimento di Scienze Mediche, Azienda Ospedaliera Sant’Anna, Ferrara, Italy.
  19. Policlinico Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
  20. Rheumatology Unit, Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Florence, Italy.
  21. Rheumatology Unit, Department of Clinical and Biological Sciences, Università degli Studi di Torino, Azienda Ospedaliera Ordine Mauriziano di Torino, Italy.
  22. Rheumatology Unit, DiMePreJo, University of Bari, Italy.
  23. Rheumatology Unit, University Hospital Città della Salute e della Scienza di Torino, Italy.
  24. Rheumatology Unit, Azienda Ospedaliera Universitaria Integrata di Verona, Policlinico Borgo Roma, Verona, Italy.
  25. Rheumatology Clinic, Università Politecnica delle Marche, Jesi, Ancona, Italy.
  26. Rheumatology, ASL BT Andria, Barletta, Italy.
  27. Rheumatology Unit, University Statale di Milano, IRCCS Galeazzi-Sant’ Ambrogio, Milan, Italy.
  28. Rheumatology Unit, University of Modena and Reggio Emilia, Modena, Italy.
  29. Rheumatology, ASL Taranto P.O. "Valle d'Itria" Martina Franca, Taranto, Italy.
  30. Policlinico Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy.
  31. Rheumatology Unit, DiMePreJo, University of Bari, Italy.
  32. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy. roberta.ramonda@unipd.it

  1. Reumatologia e Immunologia Clinica, ASST- Spedali Riuniti Civili Brescia, Italy.
  2. Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Florence, Italy.
  3. Department of Medical and Surgical Sciences, University of Foggia, Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Foggia”, Foggia, Italy.
  4. UOC di Reumatologia, AOU e Università di Cagliari, Monserrato, Cagliari, Italy.
  5. Rheumatology Clinic, Department of Rheumatology and Medical Sciences, ASST G.Pini-CTO, Milan, Italy.
  6. Rheumatology Unit, University Hospital Città della Salute e della Scienza di Torino, Italy.
  7. Reumatologia, Dipartimento di Scienze Mediche, Azienda Ospedaliera Sant’Anna, Ferrara, Italy.
  8. Reumatologia, Dipartimento di Scienze Mediche, Azienda Ospedaliera Sant’Anna, Ferrara, Italy.
  9. Rheumatology Unit, Department of Clinical Internal, Anaesthesiological and Cardiovascular Sciences, Sapienza University of Rome, Italy.
  10. Rheumatology Unit, Department of Clinical and Biological Sciences, Università degli Studi di Torino, Azienda Ospedaliera Ordine Mauriziano di Torino, Italy.
  11. Department of Internal Medicine and Therapeutics, University of Pavia; and Division of Rheumatology, IRCCS Policlinico S. Matteo Foundation, Pavia, Italy.
  12. Rheumatology Unit, University of Modena, Modena, Italy.
  13. Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Italy.
  14. Rheumatology Unit, Department of Medicine DIMED, University Hospital of Padova, Italy.
  15. Rheumatology Unit, DiMePreJo, University of Bari, Italy.
  16. Policlinico San Marco University Hospital of Catania, Rheumatology Unit, Catania, Italy.

on behalf of the GISEA Study Group

CER16571
2024 Vol.42, N°1
PI 0104, PF 0114
Full Papers

purchase article

PMID: 37650298 [PubMed]

Received: 08/02/2023
Accepted : 05/07/2023
In Press: 30/08/2023
Published: 24/01/2024

Abstract

OBJECTIVES:
We aimed to investigate the effectiveness of tumour necrosis factor inhibitors (TNFi), anti-interleukin-17 or interleukin-12/23 monoclonal antibodies (anti-IL) on comorbidities in a cohort of patients with spondyloarthritis (SpA), using an average treatment effect (ATE) analysis.
METHODS:
SpA patients from the multicentre Italian GISEA Registry were divided into groups according to pharmacological exposure: no treatment (G0), TNFi (G1) and non-responders to TNFi switched to anti-IL (G2). In each group, we recorded the prevalence and incidence of infectious, cardiopulmonary, endocrinological, gastrointestinal, oncologic, renal and neurologic comorbidities. Each comorbidity was then fitted for ATE and baseline features were evaluated for importance.
RESULTS:
The main findings of this study comprising 4458 SpA patients relate to cancer, other gastrointestinal diseases (OGID) and fibromyalgia. ATE showed no increased risk of solid cancer in G1 (0.42 95% CI 0.20–0.85) and G2 (0.26 95% CI 0.08–0.71) vs. G0, with significantly higher incidence in G0 (14.07/1000 patient-years, p=0.0001). Conversely, a significantly higher risk of OGID and fibromyalgia was found in G1 (1.56 95% CI 1.06–2.33; 1.69 95% CI 1.05–2.68, respectively) and G2 (1.91 95% CI 1.05–3.24; 2.13 95% CI 1.14–3.41, respectively) vs. G0. No treatment risk reduction was observed in haematological malignancies, cardiovascular events and endocrinological comorbidities.
CONCLUSIONS:
Overall, our study confirms the safety of TNFi and anti-IL in SpA patients, albeit with some caveats pertaining to solid cancers, OGID and fibromyalgia. Furthermore, taking into consideration causality with observational data may yield more reliable and relevant clinical information.

DOI: https://doi.org/10.55563/clinexprheumatol/q38lu0

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