Hand Bone Loss in Early Rheumatoid Arthritis Is Independent of Adalimumab Treatment - Results from a Randomized Controlled Clinical Trial.

Lykke Midtbøll Ørnbjerg¹, Mikkel Østergaard², Trine David Jensen³, Kim Hørslev-Petersen⁴, Kristian Stengaard-Pedersen⁵, Peter Junker⁶, Torkell Ellingsen⁷, Palle Ahlquist⁸, Hanne Lindegaard⁹, Asta Linauskas¹⁰, Annette Schlemmer¹¹, Mette Yde Dam⁷, Ib Hansen¹², Tine Lottenburger⁸, Christian G. Ammitzbøll⁵, Anette Jørgensen⁵, Sophine B. Krintel¹, Johnny Lillelund Raun¹³ and Merete Lund Hetland², ¹Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark, ²Copenhagen Center for Arthritis Research, Center for Rheumatology and Spine Diseases, Rigshospitalet, Denmark, Copenhagen, Denmark, ³Department of Endocrinology, Hvidovre Hospital, Copenhagen, Denmark, ⁴King Christian X Hospital for Rheumatic Diseases, Graasten, Denmark, ⁵Department of Rheumatology, Institute of Clinical Medicine, Aarhus University Hospital, Aarhus, Denmark, ⁶Department of Rheumatology C, Odense University Hospital, Odense, Denmark, ⁷Diagnostic Centre, Silkeborg Regional Hospital, Silkeborg, Denmark, ⁸Department of Medicine, Vejle Regional Hospital, Vejle, Denmark, ⁹The DANBIO registry and the Danish Departments of Rheumatology, Odense, Denmark, ¹⁰Department of Rheumatology, Vendsyssel Hospital, Hjørring, Denmark, ¹¹9Department of Rheumatology, Aalborg University Hospital, Aalborg, Denmark, ¹²Department of Rheumatology, Viborg Regional Hospital, Viborg, Denmark, ¹³King Christian X Hospital for Rheumatic Diseases, South Jutland Hospital, Graasten, Denmark

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: adalimumab and rheumatoid arthritis (RA), Digital X-ray Radiogrammetry (DXR)

Session Information

Date: Monday, November 14, 2016

Title: Imaging of Rheumatic Diseases - Poster II: XR/CT/PET/MRI

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: Rheumatoid arthritis (RA) is characterised by progressive destruction of joint bone and loss of periarticularbone 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. We aimed to investigate the effect of adding adalimumab to a methotrexate and intra-articular triamcinolone treat-to-target strategy on one-year hand bone loss (HBL_one-year) in early rheumatoid arthritis (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 (DTotal Sharp/van der Heijde Score (TSS) as dependent variable) and logistic (+/-radiographic progression (DTSS>0) as dependent variable) regression analyses. Variables with p<0.10 were included in multivariable models.

Results: In 70 patients with available HBL_one-year data, HBL_one-year was median (InterQuartileRange(IQR)) -1.9 (-3.3;-0.26 mg/cm²) in the placebo-group and -1.8 (-3.6;0.06) mg/cm²in the adalimumab-group, p=0.98,Mann Whitney (Figure 1). 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 DTSS after two years (β=-0.086 (95% Confidence Interval=-0.15;-0.025) TSS unit/mg/cm² increase,p=0.006), and borderline associated with presence of radiographic progression (DTSS>0) (OR 0.96(0.92-1.0), p=0.10).

Conclusion: 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 DTSS after two years. References: 1) Hørslev-Petersen et al. Ann Rheum Dis. 2015 doi: 10.1136/annrheumdis-2015-208166. 2) Ørnbjerg LM et al. Arthritis Research & Therapy.2016, 18:53

Disclosure: L. M. Ørnbjerg, None; M. Østergaard, None; T. D. Jensen, None; K. Hørslev-Petersen, None; K. Stengaard-Pedersen, None; P. Junker, None; T. Ellingsen, None; P. Ahlquist, None; H. Lindegaard, None; A. Linauskas, None; A. Schlemmer, None; M. Yde Dam, None; I. Hansen, None; T. Lottenburger, None; C. G. Ammitzbøll, None; A. Jørgensen, None; S. B. Krintel, None; J. L. Raun, None; M. Lund Hetland, AbbVie, BMS, MSD, Roche, Pfizer, UCB, Crescendo, 2.

To cite this abstract in AMA style:

Ørnbjerg LM, Østergaard M, Jensen TD, Hørslev-Petersen K, Stengaard-Pedersen K, Junker P, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Yde Dam M, Hansen I, Lottenburger T, Ammitzbøll CG, Jørgensen A, Krintel SB, Raun JL, Lund Hetland M. Hand Bone Loss in Early Rheumatoid Arthritis Is Independent of Adalimumab Treatment – Results from a Randomized Controlled Clinical Trial. [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/hand-bone-loss-in-early-rheumatoid-arthritis-is-independent-of-adalimumab-treatment-results-from-a-randomized-controlled-clinical-trial/. Accessed .

« Back to 2016 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/hand-bone-loss-in-early-rheumatoid-arthritis-is-independent-of-adalimumab-treatment-results-from-a-randomized-controlled-clinical-trial/