Marco SEBASTIANI1, Andreina MANFREDI1, Florenzo IANNONE2, Elisa GREMESE3, Alessandra BORTOLUZZI4, Ennio FAVALLI5, Chiara BAZZANI6, Fausto SALAFFI7, Enrico FUSARO8, Rosario FOTI9, Chiara GIANNITTI10, Roberto CAPORALI11, Alberto CAULI12, Giulia CASSONE13, Giuseppe LOPALCO2, Luca PETRICCA3, Gianfranco FERRACCIOLI3, Giovanni LAPADULA2

1Azienda Ospedaliera Policlinico Di Modena, University of Modena and Reggio Emilia, Rheumatology Unit, Modena, Italy
2Department of Medicine, Rheumatology Unit, University of Bari, Interdisciplinary Bari, Italy
3Policlinico Gemelli Foundation, Catholic University of the Sacred Heart, Rheumatology Unit, Rome, Italy
4Department of Clinical and Experimental Medicine, Rheumatology Unit, Sant'anna Hospital, University of Ferrara, Ferrara, Italy
5Department of Rheumatology, Gaetano Pini Institute, Milan, Italy
6Spedali Civili Di Brescia, Rheumatology and Clinical Immunology Unit, Brescia, Italy
7Università Politecnica Delle Marche, Rheumatology Unit, Jesi, Italy
8Città Della Salute E Della Scienza Hospital, Rheumatology Unit, Turin, Italy
9A.o.u. Policlinico Vittorio Emanuele, Rheumatology Unit, Catania, Italy
10University of Siena, Rheumatology Unit, Siena, Italy
11Irccs Policlinico San Matteo Foundation, University of Pavia, Rheumatology Unit, Pavia, Italy
12Department of Medical Sciences, Rheumatology Unit, Policlinico of the University of Cagliari, Cagliari, Italy
13Department of Clinical and Experimental Medicine, University of Modena and Raggio Emilia, Modena, Italy

Keywords: Etanercept, predictive factors, rheumatoid arthritis, treatment failure


Objectives: This study aims to investigate the factors associated with early discontinuation (within one year) of etanercept (ETA) in rheumatoid arthritis (RA) patients who began ETA as first biologic disease-modifying antirheumatic drug (bDMARD) and who were entered into the Gruppo Italiano di Studio sulla Early Arthritis (Italian Group for the Study of Early Arthritis; GISEA) registry.

Patients and methods: This registry-based cohort study included 477 RA patients (95 males, 382 females; median age 53 years; range 18 to 83 years) who began ETA as first bDMARD. Patient demographics, disease features and drugs were re-evaluated after 12 months. Baseline predictors of ETA discontinuation were estimated by univariate and multivariate analyses using Cox regression model.

Results: Seventy patients (14.7%) discontinued ETA during the first year (for inefficacy in 55.8%, adverse events in 28.6%, and other reasons in 6.5%). Concurrent conventional synthetic DMARDs (csDMARDs) were reported in 54.3% of patients, mainly methotrexate (MTX), while 52.4% of subjects took low doses of glucocorticoids. Patients stopping ETA more frequently showed one or more comorbidities, mainly cardiovascular diseases (28.6% vs. 15.7% in patients stopping and continuing ETA, respectively, p=0.009). The presence of comorbidities and a combination therapy with csDMARDs other than MTX were independent factors associated with early discontinuation of ETA at multivariate Cox analysis.

Conclusion: Although ETA demonstrated a high persistence in biologic-naïve RA patients, about 15% of patients discontinued the treatment within 12 months. The presence of comorbidities and a combination therapy with csDMARDs other than MTX were the main factors for an early withdrawal of the drug.