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 (NCT 00908089).