RESUMO
OBJECTIVES: To assess long-term drug survival and effectiveness in biological drug-naïve patients with rheumatoid arthritis (RA), starting infliximab as first treatment, in the period 2000-2009, comparing different calendar years. METHODS: Patients with RA recorded in the GISEA registry beginning infliximab as first ever biological drug were enrolled, subdivided into periods 2000-2002, 2003-2005, and 2006-2009. We evaluated 5-year drug survival by Kaplan-Meier life analysis and 1-year EULAR responses based on the 28 joint count Disease Activity Score (DAS28), and baseline predictors, by multiple logistic regression analysis. RESULTS: Of 565 RA patients included in the analysis, 290 (51.3%) began infliximab in years 2000-2002, 167 (29.5%) in 2003-2005, and 108 (19.1%) in 2006-2009. At entry, DAS28-ESR was significantly lower in 2006-2009 (5.1 ± 1.3) than in 2000-2002 (6.0 ± 1.2) or 2003-2006 (6.0 ± 1.0) (p=0.001). Significantly more RA patients attained a EULAR "good" response at 1 year in 2006-2009 (39.8%) than in 2000-2002 (23.1%, p=0.001). Nevertheless, the rate of drug survival at 5 years, roughly 40%, was not significantly different over the calendar periods. Co-administration of DMARDs was significantly correlated with drug survival (Odds Ratio (OR) 1.42, 95% Confidence Intervals (CI) 1.005-2.09, p=0.04), but not the period when starting treatment. Instead, a EULAR "good" response was significantly correlated with the period 2006-2009 (OR 2.24, 95% CI 1.37-3.65, p=0.02). CONCLUSIONS: Our study shows that RA patients have similar drug survival on infliximab regardless of the period when they started. However, patients treated in more recent years tend to have less active RA and to more readily attain favourable clinical outcomes.