FRI0535 Hand Bone Loss in Early Rheumatoid Arthritis Is Independent of Adalimumab Treatment. A Substudy of The Optimized Treatment Algorithm in Early RA (Opera) Trial

Background Rheumatoid arthritis (RA) is characterised by progressive destruction of joint bone and loss of periarticular bone mineral. Hand bone loss (HBL) measured by Digital X-ray Radiogrammetry (DXR) has been proposed as a sensitive outcome measure for treatment effect and as a potential predictor of subsequent radiographic progression in RA patients. Objectives To investigate the effect of adding adalimumab to a methotrexate and intra-articular triamcinolone treat-to-target strategy on one-year HBL (HBL one-year ) in early RA and to determine if HBL 6months is associated with radiographic progression after two years. Methods In a clinical trial (OPERA) of 180 treatment-naive early RA patients (1), bone mineral density (BMD) was estimated from hand radiographs with Digital X-ray radiogrammetry (DXR) at baseline, after 6 months (n=90) and 12 months (n=70) of follow-up. Baseline and two-year radiographs were scored according to the Sharp/van der Heijde method. Baseline characteristics and HBL 6months (0–6 months changes in DXR-BMD) were investigated as predictors of structural damage by univariate linear (ΔTotal Sharp/van der Heijde Score (TSS) as dependent variable) and logistic (+/− radiographic progression (ΔTSSu003e0) as dependent variable) regression analyses. Variables with p Results In 70 patients with available HBL one-year data, HBL one-year was median (InterQuartileRange (IQR)) -1.9 (-3.3; -0.26 mg/cm 2 ) in the placebo-group and -1.8 (-3.6; 0.06) mg/cm 2 in the adalimumab-group, p=0.98,Mann Whitney. Increased HBL (compared to general population reference values (2)) was found in 26/37 and 23/33 patients in the placebo- and adalimumab-groups, Chi-sq=0.99. In 90 patients with HBL 6months data and two-year radiographic data, HBL 6months was independently associated with ΔTSS after two years (β=-0.086 (95% Confidence Interval= -0.15; -0.025) TSS unit/mg/cm 2 increase,p=0.006), and borderline associated with presence of radiographic progression (ΔTSSu003e0) (OR 0.96 (0.92–1.0), p=0.10). Conclusions In early RA, adding adalimumab to a methotrexate-based treat-to-target strategy had no impact on HBL one-year , which was increased in both treatment groups. HBL 6months was independently associated with ΔTSS after two years. References Horslev-Petersen et al. Ann Rheum Dis. 2015 doi: 10.1136/annrheumdis-2015-208166. Ornbjerg LM et al. [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). Disclosure of Interest L. Ornbjerg: None declared, M. Ostergaard Grant/research support from: Abbvie, BMS, Boehringer-Ingelheim, Eli Lilly, Janssen, Merck, Pfizer, Roche, UCB, Celgene, Sanofi, Regeneron, Novartis, T. Jensen: None declared, K. Horslev-Petersen Grant/research support from: Abbvie, Meda, Roche, K. Stengaard-Pedersen Grant/research support from: Meda, Abbvie, Roche, Speakers bureau: UCB, Pfizer, P. Junker: None declared, T. Ellingsen: None declared, P. Ahlquist: None declared, H. Lindegaard Grant/research support from: Boehringer Ingelheim, A. Linauskas: None declared, A. Schlemmer Grant/research support from: Abbvie, Roche, MSD, M. Dam: None declared, I. Hansen: None declared, T. Lottenburger: None declared, C. Ammitzboll: None declared, A. Jorgensen: None declared, S. Krintel: None declared, J. Raun: None declared, M. Hetland: None declared