Background Glucocorticoids (GCs) can rapidly reduce disease activity in many chronic inflammatory diseases. Numerous adverse events have been attributed to GCs. One of the most commonly mentioned and feared side effects is an increase in weight and BMI, especially with chronic GC use. However, data remains scarce about the impact of short term glucocorticoid remission induction schemes on BMI in patients with Early RA (ERA).
Objectives To explore the BMI evolution of patients with ERA treated with short term glucocorticoid remission induction schemes in the (Care in Early RA) CareRA trial.
Methods The CareRA trial is a RCT comparing remission induction regimens in a treat-to-target approach. DMARD naïve ERA patients were stratified into a high- or low-risk arm based on classical prognostic markers. High-risk patients were randomized to COBRA Classic (Methotrexate (MTX) + Sulphasalazine + prednisone step-down from 60mg), COBRA Slim (MTX + prednisone step-down from 30mg) or COBRA Avant-Garde (MTX + Leflunomide + prednisone step-down from 30mg) scheme. Low-risk patients were randomized to MTX tight step-up (MTX-TSU) without oral GCs or COBRA Slim. Prednisone was tapered down over 6 weeks to 7.5mg in Classic and 5mg in the other COBRA arms. Oral GCs were discontinued from Week 28 and stopped at week 34. Demographics including BMI and disease parameters were routinely registered. For this analysis, only patients with all BMI parameters on all study visits during the first 52 treatment weeks were included. BMI change per group was tested with a paired t-test. Differences in BMI change between groups were tested with a student's t-test, Spearman's rho was used for correlation between variables of interest and BMI change. Finally, an adjusted linear regression model further explored the effect of treatment choice on BMI change.
Results 281 Of 379 patients were included. Figure 1 describes the evolution of BMI over 52 weeks for the different treatment strategies. Only patients on Cobra Classic had an increase in BMI after 52 weeks (p=0.003). In the High-Risk arm, change in BMI over 52 treatment weeks was larger in Classic versus Slim (High-Risk) (p<0.039) and in Classic versus Avant-Garde (p<0.001). In the Low-Risk arm, no difference between groups was found. No correlations were detected between change in BMI and cumulative GC dose, DAS28(CRP) change nor HAQ change. In the High-Risk arm, linear regression revealed a statistically significant effect of treatment strategy on BMI change, even when corrected for age, gender, GC cumulative dose, DAS28(CRP) change and HAQ change (p=0.014). No effect of treatment strategy on BMI change was seen in the Low-risk group in a similar linear regression model.
Conclusions In general, BMI changes were small with any treatment strategy. A statistically significant increase in BMI over 52 weeks was only seen with a remission induction scheme starting at a high GC dose in patients with poor prognosis ERA. No difference in BMI change over 52 weeks was seen between a remission induction scheme starting at a moderate GC dose and a treatment strategy without oral GCs in patients with good prognosis ERA.
Disclosure of Interest None declared