title: Anti-TNF treatment response in rheumatoid arthritis patients with moderate disease activity: a prospective observational multicentre study (MODERATE).
abstract: OBJECTIVE
  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.
authors.affiliation: Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy.
authors.forename: Fulvia
authors.initials: F
authors.lastname: Ceccarelli
authors.affiliation: U.O.S. Reumatologia, Medicina Interna, Ospedale S.Pietro Fatebenefratelli, Rome, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Massafra
authors.affiliation: Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Perricone
authors.affiliation: S.S.O. Reumatologia, Ospedale Civile Maggiore Borgo Trento, Verona, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Idolazzi
authors.affiliation: 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.
authors.forename: Roberto
authors.initials: R
authors.lastname: Giacomelli
authors.affiliation: Reumatologia, Medicina Clinica e Sperimentale, A.O.U. Seconda Università di Napoli, Italy.
authors.forename: Rosella
authors.initials: R
authors.lastname: Tirri
authors.affiliation: Medicina III, S.S. Reumatologia A.O.R.N. A. Cardarelli, Napoli, Italy.
authors.forename: Romualdo
authors.initials: R
authors.lastname: Russo
authors.affiliation: II Divisione Medicina Interna, ARNAS Civico Di Cristina Benfratelli, Palermo,Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pistone
authors.affiliation: 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.
authors.forename: Piero
authors.initials: P
authors.lastname: Ruscitti
authors.affiliation: Struttura Complessa Reumatologia, Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino, Italy.
authors.forename: Simone
authors.initials: S
authors.lastname: Parisi
authors.affiliation: Ambulatorio Immuno-Reumatologico, Ospedale Maggiore della Carità, Novara, Italy.
authors.forename: Pier Paolo
authors.initials: PP
authors.lastname: Sainaghi
authors.affiliation: U.O. di Medicina Interna, Ambulatorio di Reumatologia Ospedale Ninetto Melli, San Pietro V.co, Brindisi, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Cacciapaglia
authors.affiliation: MediData srl, Modena, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Zullo
authors.affiliation: Pfizer srl, Rome, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Marino
authors.affiliation: U.O.S. Reumatologia, Medicina Interna, Ospedale S.Pietro Fatebenefratelli, Rome, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Migliore
authors.affiliation: Dipartimento di Medicina Interna e Specialità Mediche, La Sapienza Università di Roma, Italy. guido.valesini@uniroma1.it.
authors.forename: Guido
authors.initials: G
authors.lastname: Valesini
mesh_terms: D000068879:Adalimumab / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D001688:Biological Products / Q000627:therapeutic use*; D000068582:Certolizumab Pegol / Q000627:therapeutic use; D018450:Disease Progression; D000068800:Etanercept / Q000627:therapeutic use; D005260:Female; D006801:Humans; D000069285:Infliximab / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors*
chemical_list: D000911:Antibodies, Monoclonal; D018501:Antirheumatic Agents; D001688:Biological Products; D014409:Tumor Necrosis Factor-alpha; C529000:golimumab; D000069285:Infliximab; D000068879:Adalimumab; D000068800:Etanercept; D000068582:Certolizumab Pegol