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Clin Exp Rheumatol. 2017 Jan-Feb;35(1):24-32. Epub 2016 Dec 9.

Anti-TNF treatment response in rheumatoid arthritis patients with moderate disease activity: a prospective observational multicentre study (MODERATE).

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Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy.
U.O.S. Reumatologia, Medicina Interna, Ospedale S.Pietro Fatebenefratelli, Rome, Italy.
S.S.O. Reumatologia, Ospedale Civile Maggiore Borgo Trento, Verona, Italy.
Chair and Clinical Unit of Rheumatology, Department of Biotechnological and Applied Clinical Science, School of Medicine, 'San Salvatore' University Hospital, University of L'Aquila, Italy.
Reumatologia, Medicina Clinica e Sperimentale, A.O.U. Seconda Università di Napoli, Italy.
Medicina III, S.S. Reumatologia A.O.R.N. A. Cardarelli, Napoli, Italy.
II Divisione Medicina Interna, ARNAS Civico Di Cristina Benfratelli, Palermo,Italy.
Struttura Complessa Reumatologia, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Italy.
Ambulatorio Immuno-Reumatologico, Ospedale Maggiore della Carità, Novara, Italy.
U.O. di Medicina Interna, Ambulatorio di Reumatologia Ospedale Ninetto Melli, San Pietro, Brindisi, Italy.
MediData srl, Modena, Italy.
Pfizer srl, Rome, Italy.
Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy.



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.


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.


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.


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.

[Indexed for MEDLINE]

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