Cohen SB et al. – Addition of twice-yearly injections of denosumab to ongoing methotrexate treatment inhibited structural damage in patients with RA for up to 12 months, with no increase in the rates of adverse events as compared with placebo. Methods
A phase II study to evaluate the effects of denosumab on structural damage in RA pts receiving methotrexate treatment
RA pts received sc placebo (n=75), denosumab 60 mg (n=71), or denosumab 180 mg (n =72) injections/6mos x12mos
The primary end point was the change from baseline in the MRI erosion score at 6 mos
Results
At 6 mos, the increase in the MRI erosion score from baseline was lower in the 60-mg and 180-mg denosumab groups vs placebo
A difference in the modified Sharp erosion score was observed as early as 6 mos in the 180-mg denosumab group, and at 12 mos both the 60-mg and the 180-mg denosumab groups vs placebos
Denosumab caused sustained suppression of markers of bone turnover
There was no evidence of an effect of denosumab on joint space narrowing or on measures of RA disease activity
Rates of AEs were comparable between the denosumab and placebo groups
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