Please cite this article in press as: Atzeni F, et al. Predictors of response to anti-TNF therapy in RA patients with moderate or high DAS28 scores. Joint Bone Spine (2013), doi:10.1016/j.jbspin.2013.04.005 ARTICLE IN PRESS G Model BONSOI-3859; No. of Pages 4 Joint Bone Spine xxx (2013) xxx–xxx Available online at www.sciencedirect.com Original article Predictors of response to anti-TNF therapy in RA patients with moderate or high DAS28 scores Fabiola Atzeni a,∗ , Sara Bongiovanni a , Antonio Marchesoni b , Matteo Filippini c , Roberto Caporali d , Roberto Gorla c , Lorenzo Cavagna d , Ennio Giulio Favalli b , Francesco Saccardo e , Piercarlo Sarzi-Puttini a a Rheumatology Unit, L.Sacco University Hospital of Milan, Milan, Italy b Day Hospital of Rheumatology, G. Pini Orthopedic Institute, Chair of Rheumatology in Milan, Milan, Italy c Rheumatology and Immunology Unit, Spedali Civili di Brescia, Brescia, Italy d Chair of Rheumatology, IRCCS Policlinico S. Matteo, Pavia, Italy e Internal Medicine, Ospedale di Saronno, A.O. Busto Arsizio, Saronno, Italy a r t i c l e i n f o Article history: Accepted 6 April 2013 Available online xxx Keywords: High and moderate disease activity DAS28 scores Predictive factors Anti-TNF a b s t r a c t Objectives: To identify the clinical factors predicting a good clinical response to anti-TNF therapy in rheumatoid arthritis (RA) patients entered in the LORHEN registry after 5 years of treatment with anti- TNF agents and divided into two groups on the basis of their baseline DAS28 scores (moderate > 3.2–5.1 [MDA] and high > 5.1 [HDA]). Methods: Disease activity at baseline and after 12 months was assessed using the DAS28, and response was evaluated using the EULAR improvement criteria. Results: The study involved 1300 patients with established RA: 975 with HDA and 325 with MDA. After a mean 36-month, 29.6% of the patients had a DAS28 score of less or equal to 2.6 (HDA 25.8% vs. MDA 43.0%; P < 0.001) and were considered to be in remission. A higher probability of a good EULAR response in patients with HDA was associated with male gender (F vs. M – OR 0.45, 95% CI 0.26–0.78; P: 0.004), lower age at the start of treatment (OR 0.98, 95% CI 0.96–0.99; P: 0.002), the absence of comorbidities (OR 0.18, 95% CI 0.06–0.52; P: 0.002) or no previous use of corticosteroids (OR 1.92, 95% CI 1.14–3.22; P: 0.015) and the use of adalimumab vs. infliximab (OR 2.21, 95% CI 1.37–3.57; P 0.001); in patients with MDA, the probability of a good EULAR response was associated with male gender (F vs. M – OR 0.39, 95% CI 0.17–0.90; P: 0.027). Conclusions: With the exception of male gender, the factors predicting a good EULAR response are different in patients with MDA and those with HDA. © 2013 Société franc ¸ aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved. 1. Introduction A number of studies [1–4] have found that patients who start anti-tumour necrosis factor (TNF) therapy with lower 28-joint disease activity scores (DAS28 scores) are more likely to achieve disease remission (defined as a DAS28 score of less than 2.6), but less likely to achieve a 50% or 70% improvement in disease activ- ity as defined by the American College of Rheumatology (ACR) response criteria [5]. The British Society for Rheumatology Biologics Register (BSRBR) has shown that treatment with anti-TNF therapy is effective in patients with high (HDA) or moderate disease activity (MDA) [6], and that anti-TNF therapy may be similarly cost effective in both groups as assessed using health economic models based on changes in Health Assessment Questionnaire (HAQ) scores. ∗ Corresponding author. E-mail address: atzenifabiola@hotmail.com (F. Atzeni). Various studies have investigated the clinical predictors of response to traditional disease-modifying anti-rheumatic drugs (DMARDs) and anti-TNF agents [6,7], and a recent systematic review has identified a number of independent predictors of remis- sion: i.e. baseline clinical and laboratory characteristics and genetic markers, including male gender, young age, late-onset RA, a short disease duration, being a non-smoker, low baseline disease activ- ity, the absence of rheumatoid factor (RF) and anti-citrullinated peptide, and the concurrent use of DMARDs in anti-TNF-treated patients. However, the predictive value of these prognostic factors needs to be confirmed [7]. No previous study has compared predictors of response in RA patients with MDA (DAS28 scores of 3.2-5.1) or HDA (DAS28 scores of more than 5.1). The aim of this study was to identify the clinical factors predicting a good clinical response to anti-TNF in the RA patients with MDA or HDA entered in the Lombardy Rheumatology Network (LORHEN) registry after 5 years of treatment with anti- TNF agents [8]. 1297-319X/$ – see front matter © 2013 Société franc ¸ aise de rhumatologie. Published by Elsevier Masson SAS. All rights reserved. doi:10.1016/j.jbspin.2013.04.005