Safety profile of biologic agents for Behçet's disease in a multicenter observational cohort study.
OBJECTIVE
The primary aim of this study was to explore the safety profile of biologic treatments in Behçet's disease (BD), based on their mechanism of action; the secondary aim was to study any potential variation in terms of retention rate according to each single drug.


METHODS
We studied a total of 85 treatment regimens with biologic agents from 64 patients. The total follow-up was calculated as 8640 patient-years (anti-tumor necrosis factor [TNF]-alpha 7.020, anti-interleukin [IL]-beta 1.368). Cumulative rates of drug retention were studied using the Kaplan-Meier plot and covariates in the regression model included the mechanism of action of the biologic agent, other concomitant therapies, disease duration, sex, age at start of drug therapy; for each confounding factor hazard ratios (HR) were calculated.


RESULTS
The most frequently prescribed biologic treatments were anti-TNF-alpha agents (79%), while anti-IL1-beta was used in the remaining regimens. Concomitant disease-modifying antirheumatic drugs were prescribed in 36% of patients, mainly cyclosporine and methotrexate, while in 35/85 regimens low-dose glucocorticoids were associated. During the follow-up, in all but one regimen the safety profile was free of any adverse events or serious adverse events; we observed only one case of endocarditis, reported during the 10th month of etanercept.


CONCLUSIONS
Data from a large multicenter cohort suggest that anti-TNF-alpha and anti-IL1-beta agents are characterized by an excellent safety profile in BD.
Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
Luca
L
Cantarini
Department of Clinical and Experimental Medicine, Rheumatology Unit, University of Pisa, Pisa, Italy.
Rosaria
R
Talarico
Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Milan, Italy.
Elena
E
Generali
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Giacomo
G
Emmi
Interdisciplinary Department of Medicine, Rheumatology Unit, Policlinic Hospital, University of Bari, Bari, Italy.
Giuseppe
G
Lopalco
Department of Clinical Medicine and Surgery, Rheumatology Unit, University Federico II, Naples, Italy.
Luisa
L
Costa
Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.
Elena
E
Silvestri
Department of Clinical Medicine, Rheumatology Unit, DIMED, University of Padua, Padua, Italy.
Francesco
F
Caso
Ophthalmology and Neurosurgery Department, University of Siena, Siena, Italy.
Rossella
R
Franceschini
Department of Pediatrics, Rheumatology Unit, Anna Meyer Children's Hospital and University of Florence, Florence, Italy.
Rolando
R
Cimaz
Interdisciplinary Department of Medicine, Rheumatology Unit, Policlinic Hospital, University of Bari, Bari, Italy.
Florenzo
http://orcid.org/0000-0003-0474-5344
F
Iannone
Department of Medical Sciences, Surgery and Neurosciences, Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, University of Siena, Siena, Italy.
Mauro
M
Galeazzi
Division of Rheumatology and Clinical Immunology, Humanitas Research Hospital, Rozzano, Milan, Italy.|BIOMETRA Department, University of Milan, Milan, Italy.
Carlo
C
Selmi
D000293:Adolescent; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001528:Behcet Syndrome / Q000175:diagnosis / Q000188:drug therapy* / Q000276:immunology; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D053583:Interleukin-1beta / Q000037:antagonists & inhibitors / Q000276:immunology; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000276:immunology; D055815:Young Adult
D018501:Antirheumatic Agents; D001688:Biological Products; C508585:IL1B protein, human; D053583:Interleukin-1beta; D014409:Tumor Necrosis Factor-alpha
anakinra; biotherapies; canakinumab; interleukin-1 (IL-1); tumor necrosis factor (TNF)-alpha