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Prednisone/methotrexate more effective than methotrexate for early RA patients
Low-dose oral prednisone combined with methotrexate led to a higher proportion of clinical remission and power Doppler negativity compared with methotrexate monotherapy for patients with early rheumatoid arthritis in a recent study.
Two hundred twenty patients with early rheumatoid arthritis (RA), defined as less than 1 year from clinical onset, were included in the open-label randomized 12-month clinical study. Researchers assigned 110 patients to the methotrexate and oral prednisone (MTX+PDN) group and 110 patients to the MTX monotherapy group. After follow-up, 186 patients were evaluable: 96 in the MTX+PDN group and 90 in the MTX group.
Ultrasonography examination, including a 12-joint assessment, of patients’ hands was performed at baseline, 6 months and 12 months. Researchers used a four-variable Disease Activity Score 28 (DAS28) to analyze data at baseline and at 2, 4, 6, 9 and 12 months.
Grey-scale and power Doppler (PD) also were used to score at each joint (0-3, with 3 being severe).
At the end of follow-up, there was no statistical significance in low disease activity, according to the DAS28 between the two groups: 68 patients (75.5%) in the MTX group and 77 patients (80.2%) in the MTX+PDN group (P=.44). The MTX+PDN group, however, had greater clinical remission (RR=1.61; 95% CI, 1.08-2.04) and PD negativity rates (RR=1.31; 95% CI, 1.04-1.64) than the MTX group.
“Our results suggest that in patients with early-onset RA, the addition of low-dose oral PDN to a MTX background in the contest of a treat-to-target strategy may ensure a faster and better control of disease activity, with higher rates of both clinical remission and PD signal negativity at 1 year,” the researchers said.
“To our knowledge, this study shows for the first time that a greater clinical and subclinical effect of low-dose [glucocorticoid] co-medication over [disease-modifying antirheumatic drug] monotherapy was demonstrated in early RA patients in a controlled manner.”
The researchers added that further data on subsequent structural damage might clarify the role of such deeper control of inflammation on glucocorticoid therapy.