Glucocorticoids have been used in rheumatoid arthritis (RA) for decades and in recent years have been used as disease-modifying therapy. And although the risk/benefit ratio of glucocorticoids has been questioned, data have shown that low-dose glucocorticoids in conjunction with disease-modifying antirheumatic drugs (DMARDs) have been beneficial for RA patients. A study compared the effect of low-dose glucocorticoids plus methotrexate and hydroxychloroquine versus placebo plus methotrexate and hydroxychloroquine on symptoms, signs, and inflammation in early RA.
The study randomized 80 untreated early RA patients to either the trial group (glucocorticoids plus DMARDs) or control group (placebo plus DMARDs) for one year of treatment. Outcomes included the American College of Rheumatology 20 (ACR20) criteria, disease activity score (DAS) 28- erythrocyte sedimentation rate (ESR), visual analog scale scores, joint function, health assessment questionnaire-disability index score, morning stiffness duration, C-reaction protein, and ESR. Clinical outcomes were assessed at baseline and months one, three, six and 12. A revised OMERACT RAMRIS Scoring System was used to collect MRI data of each patient’s most swollen joint pre- and posttreatment. Patients were also monitored for side effects including gastrointestinal reactions, liver dysfunction, upper respiratory tract infection, and leukocyte reduction.
After one month of treatment, ACR20 response was achieved by 55% of the glucocorticoids group and 20% of the placebo group. At month three, 85.0% of the glucocorticoids group and 47.5% of the placebo group achieved ACR20 response; at months six and 12, the rates were 87.5% versus 60.0%, respectively, and 90.0% versus 72.5%, respectively (P<0.05 for all). During the first half of the treatment period, the trial group had significantly lower DAS28-ESR scores than the control group. Inflammation, quality of life, and radiological symptoms improved significantly in the glucocorticoids group. Bone erosion did not change in the trial group and worsened in the control group. The correlation coefficient between disease duration and DAS28-ESR score was 0.496 for month one, 0.464 for month three, 0.509 for month six, and 0.550 for month 12. Rates of adverse events (AEs) did not largely differ between the groups.
Reporting in Medicine, the researchers concluded that low-dose glucocorticoids plus DMARDs methotrexate and hydroxychloroquine provided “excellent results” in patients with early RA, leading to significant improvements in symptoms, signs, and inflammation compared to placebo plus DMARDs without increasing the risk for AEs.