Background/Purpose: The Care in early Rheumatoid Arthritis (CareRA) trial compares different combinations of csDMARDs with remission induction glucocorticoid (GC) schemes starting at high or moderate dosages in a treat to target approach. Efficacy results after 52 weeks showed high rates of DAS28(CRP) remission reaching >60%. However, many physicians are still reluctant to use such regimens in practice for fear of side effects. This study explores the risk-benefit balance of GC-based intensive treatment strategies.

Methods: DMARD unexperienced Early Rheumatoid Arthritis (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 stepdown from 60mg), COBRA Slim (MTX + prednisone stepdown from 30mg) or COBRA Avant-Garde (MTX + Leflunomide + prednisone stepdown from 30mg). 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 stopped at week 34. DMARD monotherapy was aimed for in all strategies. Demographics and disease parameters were routinely registered. All patients attending the week 52 visit in CareRA were analyzed. Remission, low disease activity, obesity and arterial hypertension were defined as DAS28(CRP)<2.6, DAS28(CRP)≤3.2, BMI ≥30 kg/m² and systolic/diastolic blood pressure ≥140/90 mmHg. This analysis describes trial effectiveness, effects of treatment on BMI and blood pressure, and safety events of interest.

Results: Of the 379 patients included in our trial, 349 (91.3%) attended week 52. Remission and low disease activity were achieved in 227/349 (65.6%) and 278 (80.3%) patients respectively, with 236 (68.2%) patients on MTX monotherapy. The therapeutic strategy could be followed per protocol by 263 (75.4%) patients. Of patients not able to follow the protocol 26 (7.4%) were using biologicals and 18 (5.2%) GCs. Table 1 gives detailed information per treatment strategy. BMI changed 0.0 ±3.2 kg/m² after 52 treatment weeks. The proportion of obese patients did not rise between baseline and week 52 (20.1% vs 20.3%). Systolic and diastolic blood pressure changed -0.9 ±15.8 mmHg and -0.4 ±10.6 mmHg respectively, without a significant change in the proportion of hypertensive patients (10.7% vs 6.1%).  The only difference between treatments arms in either risk groups was a BMI decrease in Avant-Garde compared to Classic and Slim between baseline and week 52 (p=0.01). Diabetes and glucose intolerance were reported only once, in Cobra Slim and Classic respectively. Hyperglycaemia was reported once in Classic, Avant-Garde and MTX-TSU. Glycosuria was reported in 1 Avant-Garde patient. No differences between groups were observed in infection rate. Most common were respiratory infections.

Conclusion: Intensive treatment strategies using short-term glucocorticoids for remission induction show a favourable risk-benefit ratio after 1 year, with only a small proportion of patients requiring biologics and no need for prolonged GC use in ERA.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/glucocorticoids-in-early-rheumatoid-arthritis-management-friend-or-foe/