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
Authors: L.M. Ørnbjerg, M. Østergaard, T. Jensen, K. Hørslev-Petersen, K. Stengaard-Pedersen, P. Junker, T. Ellingsen, P. Ahlquist, H. Lindegaard, A. Linauskas, A. Schlemmer, M.Y. Dam, I. Hansen, T. Lottenburger, C.G. Ammitzbøll, A. Jørgensen, S. Krintel, J. Raun, M. Hetland
Journal: Annals of the Rheumatic Diseases (2016)

<h3>Background</h3> 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. <h3>Objectives</h3> To investigate the effect of adding adalimumab to a methotrexate and intra-articular triamcinolone treat-to-target strategy on one-year HBL (HBL<sub>one-year</sub>) in early RA and to determine if HBL<sub>6months</sub> is associated with radiographic progression after two years. <h3>Methods</h3> 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<sub>6months</sub> (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 (ΔTSS&gt;0) as dependent variable) regression analyses. Variables with p&lt;0.10 were included in multivariable models. <h3>Results</h3> In 70 patients with available HBL<sub>one-year</sub> data, HBL<sub>one-year</sub> was median (InterQuartileRange (IQR)) -1.9 (-3.3; -0.26 mg/cm<sup>2</sup>) in the placebo-group and -1.8 (-3.6; 0.06) mg/cm<sup>2</sup> 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<sub>6months</sub> data and two-year radiographic data, HBL<sub>6months</sub> was independently associated with ΔTSS after two years (β=-0.086 (95% Confidence Interval= -0.15; -0.025) TSS unit/mg/cm<sup>2</sup> increase,p=0.006), and borderline associated with presence of radiographic progression (ΔTSS&gt;0) (OR 0.96 (0.92–1.0), p=0.10). <h3>Conclusions</h3> In early RA, adding adalimumab to a methotrexate-based treat-to-target strategy had no impact on HBL<sub>one-year</sub>, which was increased in both treatment groups. HBL<sub>6months</sub> was independently associated with ΔTSS after two years. <h3>References</h3> Hørslev-Petersen et al. Ann Rheum Dis. 2015 doi: 10.1136/annrheumdis-2015-208166. Ørnbjerg LM et al. [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). <h3>Disclosure of Interest</h3> L. Ørnbjerg: None declared, M. Østergaard Grant/research support from: Abbvie, BMS, Boehringer-Ingelheim, Eli Lilly, Janssen, Merck, Pfizer, Roche, UCB, Celgene, Sanofi, Regeneron, Novartis, T. Jensen: None declared, K. Hørslev-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. Ammitzbøll: None declared, A. Jørgensen: None declared, S. Krintel: None declared, J. Raun: None declared, M. Hetland: None declared