The Effect of Low-Dose Glucocorticoids Over Two Years on Weight and Blood Pressure in Rheumatoid Arthritis: Individual Patient Data From Five Randomized Trials.

BACKGROUND

Weight gain and hypertension are well known adverse effects of treatment with high-dose glucocorticoids.

OBJECTIVE

To evaluate the effects of 2 years of low-dose glucocorticoid treatment in rheumatoid arthritis (RA).

DESIGN

Pooled analysis of 5 randomized controlled trials with 2-year interventions allowing concomitant treatment with disease-modifying antirheumatic drugs.

SETTING

12 countries in Europe.

PATIENTS

Early and established RA.

INTERVENTION

Glucocorticoids at 7.5 mg or less prednisone equivalent per day.

MEASUREMENTS

Coprimary end points were differences in change from baseline in body weight and mean arterial pressure after 2 years in intention-to-treat analyses. Difference in the change of number of antihypertensive drugs after 2 years was a secondary end point. Subgroup and sensitivity analyses were done to assess the robustness of primary findings.

RESULTS

A total of 1112 participants were included (mean age, 61.4 years [SD, 14.5]; 68% women). Both groups gained weight in 2 years, but glucocorticoids led, on average, to 1.1 kg (95% CI, 0.4 to 1.8 kg;  < 0.001) more weight gain than the control treatment. Mean arterial pressure increased by about 2 mm Hg in both groups, with a between-group difference of -0.4 mm Hg (CI, -3.0 to 2.2 mm Hg;  = 0.187). These results were consistent in sensitivity and subgroup analyses. Most patients did not change the number of antihypertensive drugs, and there was no evidence of differences between groups.

LIMITATION

Body composition was not assessed, and generalizability to non-European regions may be limited.

CONCLUSION

This study provides robust evidence that low-dose glucocorticoids, received over 2 years for the treatment of RA, increase weight by about 1 kg but do not increase blood pressure.

PRIMARY FUNDING SOURCE

None.