Factors Predicting Early Failure of Etanercept in Rheumatoid Arthritis: An Analysis From the Gruppo Italiano di Studio sulla Early Arthritis (Italian Group for the Study of Early Arthritis) Registry.

Abstract

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.

• Authors: Marco Sebastiani, Andreina Manfredi, Florenzo Iannone, Elisa Gremese, Alessandra Bortoluzzi, Ennio Favalli, Chiara Bazzani, Fausto Salaffi, Enrico Fusaro, Rosario Foti, Chiara Giannitti, Roberto Caporali, Alberto Cauli, Giulia Cassone, Giuseppe Lopalco, Luca Petricca, Gianfranco Ferraccioli, Giovanni Lapadula
• Journal: Archives of rheumatology (Arch Rheumatol) Vol. 35 Issue 2 Pg. 163-169 (Jun 2020) ISSN: 2618-6500 [Electronic] Turkey
• PMID: 32851364 (Publication Type: Journal Article)
• Copyright: Copyright © 2020, Turkish League Against Rheumatism.