TY - JOUR T1 - Effects of B-cell directed therapy on the preclinical stage of rheumatoid arthritis: the PRAIRI study JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 179 LP - 185 DO - 10.1136/annrheumdis-2017-212763 VL - 78 IS - 2 AU - Danielle M Gerlag AU - Mary Safy AU - Karen I Maijer AU - Man Wai Tang AU - Sander W Tas AU - Mirian J F Starmans-Kool AU - Astrid van Tubergen AU - Matthijs Janssen AU - Maria de Hair AU - Monika Hansson AU - Niek de Vries AU - Aeilko H Zwinderman AU - Paul P Tak Y1 - 2019/02/01 UR - http://ard.bmj.com/content/78/2/179.abstract N2 - Objectives We explored the effects of B-cell directed therapy in subjects at risk of developing autoantibodypositive rheumatoid arthritis (RA), who never experienced inflammatory arthritis before, and explored biomarkers predictive of arthritis development.Methods Individuals positive for both anti-citrullinated peptide antibodies and rheumatoid factor but without arthritis were included in a randomised, double-blind, placebo-controlled study to receive a single infusion of 1000 mg rituximab or placebo.Results Eighty-one individuals received treatment and were followed up for a mean of 29.0 (0–54) months, during which 30/81 (37%) individuals developed arthritis. The observed risk of developing arthritis in the placebo-treated group was 40%, which was decreased by 55% (HR 0.45, 95% CI 0.154 to 1.322) in the rituximab-treated group at 12 months. Rituximab treatment caused a delay in arthritis development of 12 months compared with placebo treatment at the point when 25% of the subjects had developed arthritis (p<0.0001). Erythrocyte sedimentation rate and the presence of anti-citrullinated α-enolase peptide 1 at baseline were significant predictors of arthritis development.Conclusions A single infusion of 1000 mg rituximab significantly delays the development of arthritis in subjects at risk of developing RA, providing evidence for the pathogenetic role of B cells in the earliest, prearthritis stage of autoantibody positive RA. ER -