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Abstract
Purpose Glucocorticoids (GCs) are recommended in patients with systemic lupus erythematosus (SLE), in combination with hydroxychloroquine (HCQ) or immunosuppressant, but should be tapered or discontinued in the medium to long-term to minimize detrimental effects. A sub-analysis of the multicenter Early Lupus inception cohort was performed to investigate the real-world trajectory of Glucocorticoids (GCs) Use in newly diagnosed SLE Patients (the GULP study) and the associated outcomes.
Methods The GULP study enrolled patients starting prednisone (PDN) ≥5mg/day and concomitant HCQ or immunosuppressant within 12 months of SLE classification. SLE core set variables were recorded at baseline and then every six months for 2 years, including changes in PDN dose, ECLAM and BILAG active domains. The SLICC/ACR Damage Index (SDI) and a 0–10 global health visual analog scale (GH-VAS) were also recorded. Regression models analyzed the damage accrual and GH-VAS in different GCs tapering and discontinuation trajectories.
Results Overall, 127 SLE patients with a mean age of 36.7 (± 13.4) years and a median disease duration of 6.1 (1.3 - 11.5) months were included. At baseline 98 (77.2%) patients received HCQ, 81 (63.8%) received conventional immunosuppressants, and 57 (44.9%) received a combination of them. The median daily dose of PDN at baseline was 12.5 (6.3–25.0) mg/day and significantly decreased to 5.4 (4.3–9.4) mg/day at 12-month and 4.9 (2.5–6.6) mg/day at 24-month (p<0.001). At the end of follow-up, 73 (57.5%) successfully tapered PDN doses below 5 mg/day, and 17 (13.4%) discontinued GCs within a 2-year follow-up (Figure 1). Overall, 99 (78%) patients tapered the PDN dose below 5 mg/day: 34 (26.8%) within 6 months, 35 (27.6%) within 12 months, 22 (17.3%) within 18 months and 8 (6.3%) within 24 months of follow-up; 42.4% of patients who tapered PDN and 46.4% of those who never tapered PDN below 5mg/day required to increase the PDN dose within the end of the 2-year follow-up. A higher daily dose of PDN resulted in a greater probability (OR 1.4 per mg/day; 95%CI 1.3–1.5; p<0.001) of GCs tapering regardless of disease activity, whereas ECLAM (OR 1.6; 95%CI 1.2–2.3; p=0.004) and BILAG (OR 1.9; 95%CI 1.3–3.0; p=0.004) were independently associated with the risk of increasing GCs dose. In patients taking PDN <5mg/day, daily doses remained stable in 49.3% and 52.8% of visits despite, respectively, ECLAM=0 and no BILAG activity. Every month spent on PDN<5mg/day was associated with lower damage accrual (IRR 0.96; 95%CI 0.93–0.99; p=0.007) and better GH-VAS (beta 0.60; 95%CI 0.13–1.33; p=0.108), although the latter was statistically nonsignificant.
Heatmap of the mean daily prednisone dose interval during the 24 months follow-up since diagnosis
Conclusion GCs are feasibly tapered to PDN <5mg/day maintenance dose with adequate control of disease activity and lowered damage in patients with newly diagnosed SLE, whereas physicians usually avoid GCs discontinuation in the early disease stage.
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