Abstract
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.
| Original language | English |
|---|---|
| Journal | International Journal of Rheumatic Diseases |
| DOIs | |
| Publication status | Accepted/In press - 2015 |
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Keywords
- Anakinra
- Biotherapies
- Canakinumab
- Interleukin-1 (IL-1)
- Tumor necrosis factor (TNF)-alpha
ASJC Scopus subject areas
- Rheumatology
Cite this
Safety profile of biologic agents for Behçet's disease in a multicenter observational cohort study. / Cantarini, Luca; Talarico, Rosaria; Generali, Elena; Emmi, Giacomo; Lopalco, Giuseppe; Costa, Luisa; Silvestri, Elena; Caso, Francesco; Franceschini, Rossella; Cimaz, Rolando; Iannone, Florenzo; Galeazzi, Mauro; Selmi, Carlo.
In: International Journal of Rheumatic Diseases, 2015.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety profile of biologic agents for Behçet's disease in a multicenter observational cohort study
AU - Cantarini, Luca
AU - Talarico, Rosaria
AU - Generali, Elena
AU - Emmi, Giacomo
AU - Lopalco, Giuseppe
AU - Costa, Luisa
AU - Silvestri, Elena
AU - Caso, Francesco
AU - Franceschini, Rossella
AU - Cimaz, Rolando
AU - Iannone, Florenzo
AU - Galeazzi, Mauro
AU - Selmi, Carlo
PY - 2015
Y1 - 2015
N2 - 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.
AB - 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.
KW - Anakinra
KW - Biotherapies
KW - Canakinumab
KW - Interleukin-1 (IL-1)
KW - Tumor necrosis factor (TNF)-alpha
UR - http://www.scopus.com/inward/record.url?scp=84940055654&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84940055654&partnerID=8YFLogxK
U2 - 10.1111/1756-185X.12732
DO - 10.1111/1756-185X.12732
M3 - Article
AN - SCOPUS:84940055654
JO - International Journal of Rheumatic Diseases
JF - International Journal of Rheumatic Diseases
SN - 1756-1841
ER -