Limited reduction of bone mineral density in patients with early rheumatoid arthritis receiving aggressive treatment: 10 year results of the NEO-RACo study.

Abstract

Objective: To evaluate whether rapid and sustained suppression of inflammation, using the NEO-RACo treatment, including prednisolone 7.5 mg/day for 2 years, in patients with early active rheumatoid arthritis (RA) can prevent the reduction of bone mineral density (BMD) in a 10 year follow-up.

Method: In the NEO-RACo study, 99 patients, aged 18-60 years, with early RA and without earlier use of disease-modifying anti-rheumatic drugs (DMARDs), were treated with a triple combination of conventional synthetic DMARDs and 7.5 mg prednisolone daily for 2 years and double blindly randomized to receive either placebo or infliximab infusions for the first 6 months. After 2 years, the therapies could be modified, always aiming for strict remission. All patients also received 1000 mg calcium and 800 IU vitamin D₃ daily. BMD was measured by dual-energy X-ray absorptiometry at baseline, 2 years, 5 years, and 10 years. BMD Z-score ≤ -2.0 was considered to be below the expected value.

Results: At baseline, two patients (2%) had a Z-score ≤ -2.0, including one patient with osteoporosis. At the time of the last BMD measurement, five patients (5%) had a Z-score ≤ -2.0, and no new-onset osteoporosis cases occurred. No significant differences emerged between the randomization groups.

Conclusions: Both randomization groups were treated early and aggressively, and the decrease in BMD was low throughout the 10 year follow-up. The use of infliximab during the first 6 months provided no extra benefit regarding bone loss.Trial Registration: http://www.clintrials.gov (NCT00908089).