TY - JOUR
T1 - Golimumab effectiveness in biologic inadequate responding patients with rheumatoid arthritis, psoriatic arthritis and spondyloarthritis in real-life from the Italian registry GISEA
AU - Iannone, Florenzo
AU - Favalli, Ennio G.
AU - Caporali, Roberto
AU - D'Angelo, Salvatore
AU - Cantatore, Francesco Paolo
AU - Sarzi-Puttini, Piercarlo
AU - Foti, Rosario
AU - Foti, Roberta
AU - Conti, Fabrizio
AU - Conti, Francesco
AU - Carletto, Antonio
AU - Gremese, Elisa
AU - Cauli, Alberto
AU - Ramonda, Roberta
AU - Palermo, Adalgisa
AU - Epis, Oscar
AU - Priora, Marta
AU - Bergossi, Francesca
AU - Frediani, Bruno
AU - Salaffi, Fausto
AU - Lopalco, Giuseppe
AU - Cacciapaglia, Fabio
AU - Marchesoni, Antonio
AU - Biggioggiero, Martina
AU - Bugatti, Serena
AU - Balduzzi, Silvia
AU - Carriero, Antonio
AU - Carriero, Alessandro
AU - Corrado, Addolorata
AU - Bongiovanni, Sara
AU - Benenati, Alessia
AU - Miranda, Francesca
AU - Fracassi, Elena
AU - Perra, Daniela
AU - Ferraccioli, Gianfranco
AU - Lapadula, Giovanni
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Anti-TNF
KW - Antibodies, Monoclonal
KW - Antirheumatic Agents
KW - Arthritis, Psoriatic
KW - Arthritis, Rheumatoid
KW - Biological Products
KW - Biologics
KW - Female
KW - Golimumab
KW - Humans
KW - Italy
KW - Male
KW - Registries
KW - Spondylarthritis
KW - Anti-TNF
KW - Antibodies, Monoclonal
KW - Antirheumatic Agents
KW - Arthritis, Psoriatic
KW - Arthritis, Rheumatoid
KW - Biological Products
KW - Biologics
KW - Female
KW - Golimumab
KW - Humans
KW - Italy
KW - Male
KW - Registries
KW - Spondylarthritis
UR - http://hdl.handle.net/10807/205444
U2 - 10.1016/j.jbspin.2020.07.011
DO - 10.1016/j.jbspin.2020.07.011
M3 - Article
SN - 1169-8446
VL - 88
SP - 105062-N/A
JO - Revue du Rhumatisme (English Edition)
JF - Revue du Rhumatisme (English Edition)
ER -