title: Golimumab in real-life settings: 2 Years drug survival and predictors of clinical outcomes in rheumatoid arthritis, spondyloarthritis, and psoriatic arthritis.
abstract: To assess the drug survival of golimumab, and predictors thereof, in patients affected with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) in a prospective observational cohort.
  
  
  
  This is a non-interventional, longitudinal study on RA, SpA, and PsA patients starting treatment with golimumab. Endpoints were the 2 years persistence rate of golimumab and predictors of therapy discontinuation. Drug retention was analyzed using Kaplan-Meier and Cox models. Hazard ratios (HR) of golimumab discontinuation were estimated by Cox-regression hazard models.
  
  
  
  Of 416 patients starting golimumab, 171 biologic-naïve and 245 inadequate responders to prior biologic drugs, 88 had RA, 147 SpA, and 181 PsA. Global 2 years drug retention was 70.2%, with no different hazard of discontinuation among diseases or line of biologic treatment. The strongest predictor of golimumab discontinuation was female gender (HR = 1.95). Golimumab monotherapy was associated with higher risk drug interruption (HR = 1.67). Within SpA, predictors of golimumab discontinuation were female sex (HR = 4.19), and absence of extra-articular manifestations (HR = 4.60). In PsA, duration of disease was negatively associated to drug interruption (HR = 0.93), whereas golimumab monotherapy was positively (HR = 2.21) associated. Interestingly, failing to achieve a good EULAR response at 3 months was the only predictor of golimumab discontinuation for RA patients (HR = 3.03).
  
  
  
  This study provided evidence that golimumab has high retention rate in real-life settings. SpA male patients with extra-articular manifestations, PsA patients on co-therapy with DMARDs, and RA patients attaining an early clinical response had the highest probability to continue golimumab over 2 years.
authors.affiliation: Rheumatology Unit, Department of Emergence Medicine and Transplantation (DETO), University of Bari, Piazza G Cesare, 11, 70124 Bari, Italy. Electronic address: florenzo.iannone@uniba.it.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Unità Operativa di Reumatologia, ASL BT, Andria, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Santo
authors.affiliation: Rheumatology Unit, Department of Emergence Medicine and Transplantation (DETO), University of Bari, Piazza G Cesare, 11, 70124 Bari, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Anelli
authors.affiliation: Rheumatology Hospital Unit, A.O.U. Foggia, Foggia, Italy.
authors.forename: Romano
authors.initials: R
authors.lastname: Bucci
authors.affiliation: Unità Operativa di Reumatologia, ASL Taranto, Taranto, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Semeraro
authors.affiliation: U.O. of Rheumatology, "V. Fazzi" Hospital, Lecce, Italy.
authors.forename: Laura
authors.initials: L
authors.lastname: Quarta
authors.affiliation: UOC Reumatologia Universitaria-University of Foggia, Foggia, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: D'Onofrio
authors.affiliation: Unità Operativa di Reumatologia, ASL Taranto, Taranto, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Marsico
authors.affiliation: Rheumatology Service, ASL LE-DSS, Casarano and Gallipoli, Gallipoli, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Carlino
authors.affiliation: U.O. of Rheumatology, "V. Fazzi" Hospital, Lecce, Italy.
authors.forename: Oriana
authors.initials: O
authors.lastname: Casilli
authors.affiliation: Rheumatology Unit, Department of Emergence Medicine and Transplantation (DETO), University of Bari, Piazza G Cesare, 11, 70124 Bari, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Cacciapaglia
authors.affiliation: Ambulatorio di Reumatologia Ospedale di Brindisi, Brindisi, Italy.
authors.forename: Carmelo
authors.initials: C
authors.lastname: Zuccaro
authors.affiliation: Internal Medicine Unit, S. Camillo de' Lellis Hospital, Mesagne, Italy.
authors.forename: Paola Chiara
authors.initials: PC
authors.lastname: Falappone
authors.affiliation: UOC Reumatologia Universitaria-University of Foggia, Foggia, Italy.
authors.forename: Francesco Paolo
authors.initials: FP
authors.lastname: Cantatore
authors.affiliation: U.O. of Rheumatology, "V. Fazzi" Hospital, Lecce, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Muratore
authors.affiliation: Rheumatology Unit, Department of Emergence Medicine and Transplantation (DETO), University of Bari, Piazza G Cesare, 11, 70124 Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D015535:Arthritis, Psoriatic / Q000188:drug therapy*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008137:Longitudinal Studies; D008875:Middle Aged; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012307:Risk Factors; D012737:Sex Factors; D025241:Spondylarthritis / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab
keywords: Drug survival; Golimumab; Predictors; Rheumatoid arthritis; Safety; Spondyloarthritis