Background:bDMARDs are among the most effective therapies in the management of inflammatory arthritides, but they are associated with potentially severe adverse events (AEs), particularly infection. Tapering strategies of bDMARDs for patients in remission/low disease activity (R/LDA) have demonstrated comparable efficacy to standard-dose treatments, but their safety profile has not been studied yet.Objectives:To compare the number and the causes of hospital admissions in RA patients in R/LDA continuing or tapering bDMARDs.Methods:Consecutive patients with rheumatoid arthritis (RA) evaluated between 2011 and 2017, were assigned, based on treating physician’s discretion, to continue the standard dose (STD) of bDMARDs or to undergo a predetermined tapering strategy (TAP), after being in R/LDA for two consecutive visits at least 3 months apart. Down-titration of bDMARDs was obtained by a stepwise increase of the dosing interval to achieve a reduction of about 30% (e.g. administration of etanercept every 10 days instead of weekly). Demographic, clinical data and concomitant treatments were retrospectively retrieved from the electronic charts of the outpatient clinics. Information about hospital admissions, including main diagnosis, period and duration of hospitalization, and death were retrieved from the Regional Healthcare System Database.For the STD group, the observation period started with the occurrence of remission and finished with one of these events: loss of remission, switch to another bDMARD, withdrawal of the bDMARD, severe AE, death, end of the study period in (December 2017). For the TAP group, the observation period started with tapering onset and finished with one of these events: reduction of the dosing interval due to either a relapse (according to a DAS28 increase) or to a subjective, symptomatic relapse (according to the patient’s definition), switch to another bDMARD, withdrawal of the bDMARD, severe AE, death, end of the study period in (December 2017).Results:81 patients were included, of whom 40 underwent TAP. Demographic, clinical and treatment data are shown in table 1. Baseline characteristics were comparable between the two groups, except for the number of previous bDMARDs before observational period entry that was slightly higher in the STD group (STD 1.0±0.9 versus TAP 0.5±0.8, P=0.11).Table 1.Baseline demographic and clinical characteristics of the patients in remission or low disease activity.NO TAPERING(n=41)TAPERING(n=40)p valueMean age (yrs)57±1158±130.563Mean disease duration (yrs)12±912±70.897Starting bDMARD to tapering/monitoring (months)52±4567±410.128Mean monitoring period (months)22±2419±230.632Taking sDMARD at any time ((n (%))40 (98%)37 (92%)0.359Taking glucocorticoids29 (71%)28 (70%)0.999Mean prednisone dose (mg/day)2.5±2.92.1±2.70.527DAS28 at the time of tapering or first LDA/REM2.3±0.82.3±0.90.863Previous bDMARDs >1 (n (%))10 (24.4%)4 (10%)0.140In the STD group, 14 hospital admissions occurred, while in the TAP group there were 7 admissions (p=0.128). The corresponding figures for hospital admission due to infectious diseases were 6 in the STD group and 0 in the TAP group (p=0.026).Conclusion:Tapering bDMARDs in RA patients in R/LDA is associated with fewer hospital admissions, with a possible protective effect especially toward infections.Acknowledgments:The authors are indebted with Mrs Rosella Gramuglia and Mrs Cristina Olivieri for the management and analysis of the data on the flow of the drugs, and with Mrs Anna Consigliere, Mrs Anna Cosso, Mrs Romina Petralito and Mrs Laura Ravaschio for helping in retrieving clinical data.Disclosure of Interests:Dario Camellino Consultant of: I have received consultancy fees from Celgene, Sanofi, Novartis, Janssen-Cilag, Accord, Paid instructor for: I have served as a paid instructor for Mylan, Andrea Giusti Consultant of: UCB, Amgen, Janssen, Eli Lilly, Abiogen, EffRx, Speakers bureau: UCB, Amgen, Janssen, Eli Lilly, Abiogen, EffRx, Alfa-Sigma, Chiesi, Giuseppe Girasole: None declared, Chiara Craviotto: None declared, Paola Diana: None declared, Antonia Locaputo: None declared, Tiziana Caviglia: None declared, Lacramioara Luca: None declared, Gerolamo Bianchi Consultant of: Amgen, Janssen, Merck Sharp & Dohme, Novartis, UCB, Speakers bureau: Abbvie, Abiogen, Alfa-Sigma, Amgen, BMS, Celgene, Chiesi, Eli Lilly, GSK, Janssen, Medac, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Sanofi Genzyme, Servier, UCB
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