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Randomized Controlled Trial
. 2009 Jul;68(7):1171-6.
doi: 10.1136/ard.2008.091264. Epub 2008 Sep 18.

Adalimumab therapy reduces hand bone loss in early rheumatoid arthritis: explorative analyses from the PREMIER study

Affiliations
Randomized Controlled Trial

Adalimumab therapy reduces hand bone loss in early rheumatoid arthritis: explorative analyses from the PREMIER study

M Hoff et al. Ann Rheum Dis. 2009 Jul.

Abstract

Objective: The effect of adalimumab on hand osteoporosis was examined and related to radiographic joint damage in the three treatment arms of the PREMIER study: adalimumab plus methotrexate, adalimumab and methotrexate monotherapy. Predictors of hand bone loss were also searched for.

Methods: 768 patients (537 fulfilled 2 years) with rheumatoid arthritis (RA) for less than 3 years, never treated with methotrexate, were included. Hand bone loss was assessed by digital x ray radiogrammetry (DXR) on the same hand radiographs scored with modified Sharp score at baseline, 26, 52 and 104 weeks. For DXR, metacarpal cortical index (MCI) was the primary bone measure.

Results: At all time points the rate of percentage DXR-MCI loss was lowest in the combination group (-1.15; -2.16; -3.03) and greatest in the methotrexate monotherapy group (-1.42; -2.87; -4.62), with figures in between for the adalimumab monotherapy group (-1.33; -2.45; -4.03). Significant differences between the combination group and the methotrexate group were seen at 52 (p = 0.009) and 104 weeks (p<0.001). The order of hand bone loss across the three treatment arms was similar to the order of radiographic progression. Older age, elevated C-reactive protein and non-use of adalimumab were predictors of hand bone loss.

Conclusion: This study supports a similar pathogenic mechanism for hand bone loss and erosions in RA. The combination of adalimumab and methotrexate seems to arrest hand bone loss less effectively than radiographic joint damage. Quantitative measures of osteoporosis may thus be a more sensitive tool for assessment of inflammatory bone involvement in RA.

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Conflict of interest statement

Competing interests: MH, TKK and GH have received consulting fees as speakers from Abbott Laboratories. TKK and GH have received funding for independent research from Abbott Laboratories. AE is employed by Abbott Laboratories. JK is employed by Sectra.

Figures

Figure 1
Figure 1
Flow chart of the examined patients with early rheumatoid arthritis in the present analysis. Numbers of missing x rays compared with the original PREMIER study are provided in parentheses. BMD, bone mineral density; DXR, digital x ray radiogrammetry; MCI, metacarpal cortical index; MTX, methotrexate.
Figure 3
Figure 3
Cumulative probability plot: changes in DXR–MCI and radiographic scores at 104 weeks in PREMIER. DXR, digital x ray radiogrammetry; MCI, metacarpal cortical index; mod Sharp score, modified total Sharp score; MTX, methotrexate.
Figure 2
Figure 2
Changes in DXR–MCI (percentage) and modified Sharp score (units) over time in the three treatment groups of PREMIER (A, median values; B, mean values). DXR, digital x ray radiogrammetry; MCI, metacarpal cortical index; Mod Sharp, modified total Sharp score; MTX, methotrexate.

References

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