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Effectiveness and safety of filgotinib in rheumatoid arthritis: a real-life multicentre experience

1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22

 

  1. Rheumatology Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Italy.
  2. Rheumatology Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Italy.
  3. Rheumatology Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Italy.
  4. Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Italy.
  5. Rheumatology Unit, Department of Experimental and Internal Medicine, University of Messina, Italy.
  6. Rheumatology Unit, Azienda Ospedaliera Papardo, Messina, Italy.
  7. Medical Oncology Unit, Azienda Ospedaliera Papardo, Messina, Italy.
  8. Internal Medicine Department iGR, National Relevance Hospital Trust, ARNAS Civico, Di Cristina e Benfratelli, Palermo, Italy.
  9. Internal Medicine Department iGR, National Relevance Hospital Trust, ARNAS Civico, Di Cristina e Benfratelli, Palermo, Italy.
  10. Rheumatology Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.
  11. Rheumatology Unit, Villa Sofia-Cervello Hospital, Palermo, Italy.
  12. Rheumatology Unit, Vittorio-Emanuele Hospital, Catania, Italy.
  13. Rheumatology Unit, Vittorio-Emanuele Hospital, Catania, Italy.
  14. Rheumatology Unit, Department of Medicine, Sant’Antonio Abate Hospital, Trapani, Italy.
  15. Rheumatology Unit, Department of Medicine, Sant’Antonio Abate Hospital, Trapani, Italy.
  16. Unit of Internal Medicine and Hypertension Centre, Department of Clinical and Experimental Medicine, University of Catania, Cannizzaro Hospital, Catania, Italy.
  17. Unit of Internal Medicine and Hypertension Centre, Department of Clinical and Experimental Medicine, University of Catania, Cannizzaro Hospital, Catania, Italy.
  18. Integrated Reference Centre of Rheumatology, ASP 7, Scicli Hospital, Ragusa, Italy.
  19. Integrated Reference Centre of Rheumatology, ASP 7, Scicli Hospital, Ragusa, Italy.
  20. Unit of Rheumatology, Department of Medicine, ARNAS Garibaldi Hospital, Catania, Italy.
  21. Unit of Rheumatology, Department of Medicine, ARNAS Garibaldi Hospital, Catania, Italy
  22. Rheumatology Unit, Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Italy. giuliana.guggino@unipa.it

CER17026
2024 Vol.42, N°5
PI 0991, PF 0998
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PMID: 38197190 [PubMed]

Received: 27/07/2023
Accepted : 25/10/2023
In Press: 08/01/2024
Published: 14/05/2024

Abstract

OBJECTIVES:
We investigated the effectiveness and safety of filgotinib in a real-life multicentre cohort of rheumatoid arthritis (RA) patients.
METHODS:
RA patients were evaluated at baseline and after 12 and 24 weeks and were stratified based on previous treatments as biologic disease-modifying anti-rheumatic drug (bDMARD)-naive and bDMARD-insufficient responders (IR). Concomitant usage of methotrexate (MTX) and oral glucocorticoids (GC) was recorded. At each timepoint we recorded disease activity, laboratory parameters and adverse events.
RESULTS:
126 patients were enrolled. 15.8% were bDMARD-naive (G0), while 84% were bDMARD-IR (G1). In G0, 45% of patients were in monotherapy (G2) and 55% were taken MTX (G3). In G1, 50% of patients were in monotherapy (G4) and 50% used MTX (G5).A significant reduction in all parameters at 12 weeks was observed; in the extension to 24 weeks the significant reduction was maintained for patient global assessment (PGA), examiner global assessment (EGA), visual analogue scale (VAS) pain, VAS fatigue, disease activity score (DAS)28- C-reactive protein (CRP) and CRP values. Filgotinib in monotherapy showed better outcomes in bDMARD-naive patients, with significant differences for patient reported outcomes (PROs) and DAS28-CRP. At 12 weeks, low disease activity (LDA) and remission were achieved in a percentage of 37.2 % and 10.7 % by simplified disease activity index (SDAI), 42.6 % and 5.7 % by clinical disease activity index (CDAI), 26.8 % and 25.2 % by DAS28-CRP, respectively. A significant decrease in steroid dose was evidenced in all patients. We observed a major adverse cardiovascular event in one patient and an increase in transaminase in another. No infections from Herpes Zoster were reported.
CONCLUSIONS:
Our real-world data confirm the effectiveness and safety of filgotinib in the management of RA, especially in bDMARD-naive patients.

DOI: https://doi.org/10.55563/clinexprheumatol/k78ug3

Rheumatology Article