Bone loss in patients with active early rheumatoid arthritis: infliximab and methotrexate compared with methotrexate treatment alone. Explorative analysis from a 12-month randomised, double-blind, placebo-controlled study

Objective: To examine the effect of infliximab plus methotrexate (MTX) compared with placebo plus MTX on bone loss in patients with early rheumatoid arthritis (RA) in a double-blind randomised study design. Further, to explore the associations between bone loss and markers of RA disease. Methods: All 20 patients with RA (10 patients in each treatment group) had active, early RA. Bone mineral density (BMD) was assessed at the hand, lumbar spine (L2-4) and hip by dual energy x-ray absorptiometry at baseline and 12 months' follow-up. Clinical data were collected at regular visits. Results: BMD loss was significantly reduced in the infliximab group compared with the placebo group at the femoral neck (-0.35% vs -3.43%, p = 0.01) and total hip (-0.23% vs -2.62%, p = 0.03) but not at the hand (-2.09% vs -2.82%, p = 0.82) and spine (-0.75% vs -1.77%, p = 0.71). Measures of disease process and joint damage were found to be independently associated with bone loss. Conclusions: This study provides strong evidence of a causal link between inflammation and bone loss in RA. The anti-inflammatory effect of infliximab was potent enough to arrest inflammatory bone loss at the hip but not at the spine and hand.