Golimumab effectiveness in biologic inadequate responding patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis in real-life from the Italian registry GISEA

F. Iannone*, E. G. Favalli, R. Caporali, S. D'Angelo, F. P. Cantatore, P. Sarzi-Puttini, R. Foti, F. Conti, A. Carletto, E. Gremese, A. Cauli, R. Ramonda, A. Palermo, O. Epis, M. Priora, F. Bergossi, B. Frediani, F. Salaffi, G. Lopalco, F. CacciapagliaA. Marchesoni, M. Biggioggiero, S. Bugatti, S. Balduzzi, A. Carriero, A. Corrado, S. Bongiovanni, A. Benenati, F. Miranda, E. Fracassi, D. Perra, G. Ferraccioli, G. Lapadula

*Autore corrispondente per questo lavoro

Risultato della ricerca: Contributo in rivistaArticolo

Abstract

Objective: To evaluate the clinical effectiveness of golimumab in biologic inadequate responder (IR) patients with Rheumatoid arthritis (RA), Spondyloarthritis (SpA), and Psoriatic arthritis (PsA). Methods: We analyzed 1424 patients on golimumab from the GISEA registry. Drug survival was estimated by Kaplan-Meier analysis in biologic-naïve, 1-biologic IR, ≥ 2-biologics IR patients. Hazard ratios (HRs) of discontinuing golimumab at 2 years were assessed by multivariate Cox regression. Patients achieving CDAI based low disease activity (LDA) or BASDAI < 4 were calculated at 6 and 12 months. Results: In RA (n.370), the 2-years survival on golimumab was 61.4% in 1-biologic IR, 51.9% in ≥ 2-biologics IR, and 73.1% in biologic-naive patients (P = 0.002 vs ≥ 2-biologics IR). In SpA (n.502), the survival was similar among 1-biologic IR (80%), ≥ 2-biologics IR (76.5%), and biologic-naive (74.6%) patients (P > 0.05). In PsA (n.552) the survival was 72% in 1-biologic IR, 72.5% in ≥ 2-biologics IR, and 71.8% in naïve-biologic (P > 0.05). Predictors of golimumab discontinuation were monotherapy (HR 1.65) for RA, female gender for SpA (HR 2.48) and PsA (HR 1.57). In RA, patients on CDAI-LDA were lower in 1-biologic IR (40%) or ≥ 2 biologics IR (40%) than in biologic-naïve (60%) group at 6 months (P = 0.02), but no difference was observed at 12 months. In PsA and SpA, the percentage of patients on CDAI-LDA or BASDAI < 4 at 6 months was almost identical across the subgroups. Conclusions: Golimumab had similar effectiveness in biologic-failure and biologic-naïve SpA and PsA, but seems to be less effective in multi-failure RA patients, especially as monotherapy. The best outcomes were seen in male patients.
Lingua originaleInglese
pagine (da-a)105062-N/A
RivistaJoint Bone Spine
Volume88
Numero di pubblicazione1
DOI
Stato di pubblicazionePubblicato - 2021
Pubblicato esternamente

All Science Journal Classification (ASJC) codes

  • Reumatologia

Keywords

  • Anti-TNF
  • Antibodies
  • Antirheumatic Agents
  • Arthritis
  • Biological Products
  • Biologics
  • Female
  • Golimumab
  • Humans
  • Italy
  • Male
  • Monoclonal
  • Psoriatic
  • Registries
  • Rheumatoid
  • Spondylarthritis

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