Safety profile of biologic agents for Behçet's disease in a multicenter observational cohort study

Int J Rheum Dis. 2017 Jan;20(1):103-108. doi: 10.1111/1756-185X.12732. Epub 2015 Aug 18.


Aim: 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.

Method: 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.

Conclusion: 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.

Keywords: anakinra; biotherapies; canakinumab; interleukin-1 (IL-1); tumor necrosis factor (TNF)-alpha.

Publication types

  • Comparative Study
  • Multicenter Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Antirheumatic Agents / adverse effects
  • Antirheumatic Agents / therapeutic use*
  • Behcet Syndrome / diagnosis
  • Behcet Syndrome / drug therapy*
  • Behcet Syndrome / immunology
  • Biological Products / adverse effects
  • Biological Products / therapeutic use*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Interleukin-1beta / antagonists & inhibitors
  • Interleukin-1beta / immunology
  • Italy
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Patient Safety
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors
  • Tumor Necrosis Factor-alpha / immunology
  • Young Adult


  • Antirheumatic Agents
  • Biological Products
  • IL1B protein, human
  • Interleukin-1beta
  • Tumor Necrosis Factor-alpha