OBJECTIVES: Rheumatoid arthritis (RA) patients with moderate disease activity 
show progression of joint damage and have impaired quality of life, physical 
function, work and daily activities. Little is known about management of 
patients with moderate RA. The aim of the study was to assess the 1-year 
response to anti-TNF in biologic-naïve RA patients with moderate (3.2 <DAS28 
≤5.1) disease activity despite DMARD treatment, in the Italian clinical 
practice.
METHODS: The MODERATE study is a multicentre prospective, cohort 
non-interventional study, conducted in 19 Italian rheumatology sites. Patients 
with moderate RA, diagnosed according to the 2010 American College of 
Rheumatology (ACR)/EULAR criteria, were enrolled if they also were aged ≥18 
years, had disease onset after 16 years old, moderate disease at baseline (DAS28 
score >3.2 and ≤5.1), and were naïve to anti-TNF treatment.
RESULTS: Among 157 RA patients, 93 (59%) underwent etanercept, 43 (22%) 
adalimumab, 26 (17%) certolizumab, 10 golimumab and 2 infliximab; 80% of 
patients were still in treatment after 12-month observation. One-year clinical 
remission was achieved by 27 RA patients (21%), reduction of DAS28 score greater 
than 1.2 was observed in 75 (58%) patients. Moderate and good response according 
to EULAR criteria was observed in 59 (46%) and 45 (35%) patients, respectively.
CONCLUSIONS: Results confirm the efficacy of anti-TNF alpha also in moderate RA 
patients, who may achieve a substantial decrease of disease activity, and 
improve their quality of life. The low rate of patients achieving remission may 
suggest that therapeutic strategies should be more timely and aggressive.