title: Long-term efficacy and safety of golimumab in the treatment of multirefractory Behçet's disease.
abstract: Our aim was to retrospectively assess the role of golimumab as a treatment choice in patients with Behçet's disease (BD). Seventeen patients diagnosed with BD according to the international criteria were consecutively enrolled; the BD Current Activity Form (BDCAF) was used to evaluate disease activity. After having collected clinical data from patients, statistical analysis was performed to identify differences between the start of therapy and last visit; significance was defined as p < 0.05. The mean duration of golimumab treatment was 18.47 ± 20.8 months. At the time of data enrollment, 12/17 (70.6%) patients were still on golimumab therapy. The mean time required to obtained clinical response was 4.9 ± 5.7 weeks. At 3 months evaluation, golimumab was able to control BD-related manifestations in 16/17 (94.1%) cases; the BDCAF values were significantly decreased at the last follow-up compared to those assessed at the start of golimumab (p = 0.002). The BDCAF improvement was significantly higher among patients co-administered with DMARDs than those undergoing golimumab as monotherapy (p = 0.048). At the last follow-up visit, corticosteroids had been discontinued in 10 (58.8%) patients, while the corticosteroid dosage was significantly lower at the last follow-up visit compared to the start of therapy in those patients already on corticosteroids at the end of the study (p = 0.001). Golimumab is a promising and safe treatment opportunity in BD patients with different systemic involvement, inducing a prompt resolution of clinical manifestations, a meaningful improvement of BDCAF score, and a significant corticosteroid-sparing effect. However, golimumab co-administered with DMARDs has provided better results than in patients undergoing monotherapy.
authors.affiliation: Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Vitale
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Emmi
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Lopalco
authors.affiliation: Department of Ophthalmology, Humanitas Clinical and Research Center, via Manzoni 56, 20089, Rozzano, Milan, Italy. claudia.fabiani@gmail.com.
authors.forename: Claudia
authors.initials: C
authors.lastname: Fabiani
authors.affiliation: Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Gentileschi
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Silvestri
authors.affiliation: Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
authors.forename: Di Scala
authors.initials: DS
authors.lastname: Gerardo
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
authors.forename: Florenzo
authors.initials: F
authors.lastname: Iannone
authors.affiliation: Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Frediani
authors.affiliation: Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Galeazzi
authors.affiliation: Interdisciplinary Department of Medicine, Rheumatology Unit, University of Bari, Bari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Lapadula
authors.affiliation: Institute of Pediatrics, Fondazione Policlinico Universitario "A. Gemelli", Università Cattolica Sacro Cuore, Rome, Italy.
authors.forename: Donato
authors.initials: D
authors.lastname: Rigante
authors.affiliation: Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy. cantariniluca@hotmail.com.|Rheumatology Unit, Policlinico "Le Scotte", University of Siena, viale Bracci 1, 53100, Siena, Italy. cantariniluca@hotmail.com.
authors.forename: Luca
authors.identifier: http://orcid.org/0000-0002-7352-1275
authors.initials: L
authors.lastname: Cantarini
mesh_terms: D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001528:Behcet Syndrome / Q000188:drug therapy*; D018450:Disease Progression; D005260:Female; D006801:Humans; D007558:Italy; D007826:Laryngismus / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012720:Severity of Illness Index
chemical_list: D000305:Adrenal Cortex Hormones; D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; C529000:golimumab
keywords: Autoinflammatory disease; Behçet’s disease; Biologics; Disease activity; Golimumab; TNF-α