
What's This?
Adding twice-yearly injections of denosumab to methotrexate therapy appears to inhibit structural damage in patients with rheumatoid arthritis, with no increase in the rates of adverse events relative to placebo, study data indicate.
Researchers conducted a double-blind, Phase II study in which patients with RA who were receiving methotrexate were randomized to receive add-on therapy with denosumab in doses of 60 mg (n=71) or 180 mg (n=72) or placebo injections (n=75) every 6...
Adding twice-yearly injections of denosumab to methotrexate therapy appears to inhibit structural damage in patients with rheumatoid arthritis, with no increase in the rates of adverse events relative to placebo, study data indicate.
Researchers conducted a double-blind, Phase II study in which patients with RA who were receiving methotrexate were randomized to receive add-on therapy with denosumab in doses of 60 mg (n=71) or 180 mg (n=72) or placebo injections (n=75) every 6 months for 12 months. The primary outcome measure was the change from baseline in magnetic resonance imaging erosion scores at 6 months.
The increase in mean MRI erosion scores from baseline was lower among the denosumab-treated patients at 6 months than among those who received placebo, although the difference only reached statistical significance among the patients who received the 180 mg dose of denosumab (P=.007).
Further, compared with placebo, the mean increases in modified Sharp scores were significantly lower among the patients in the denosumab 180 mg group at 6 months (P=.019) and 12 months (P=.007), and among the denosumab 60 mg group at 12 months (P=.012).
In addition, the denosumab-treated patients experienced sustained suppression of bone turnover markers and an increase in bone mineral density (BMD) relative to baseline values. However, there was no evidence of an effect on joint space narrowing or on measures of RA disease activity, the authors noted.
Rates of adverse events were comparable among all 3 treatment groups, according to the researchers.
"[T]he results of this study demonstrated that the addition of twice-yearly injections of denosumab to ongoing treatment with methotrexate inhibited structural damage, improved BMD, and suppressed bone turnover in [patients with RA], without increasing the rate of adverse events as compared with placebo treatment," the authors concluded. (Cohen SB, et al. Arthritis Rheum 2008;58:1299-1309.)
The study was supported by Amgen Inc.
This information concerns a use that has not been approved by the Food and Drug Administration.
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