The Effect of Gradual Withdrawal Versus Maintenance of Low-Dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Double-Blind Randomised Controlled Trial.

Abstract

Introduction: Abrupt discontinuation of low dose glucocorticoids (GCs) in systemic lupus erythematosus (SLE) patients with clinical quiescent disease increased the risk of flares. This study aimed to evaluate the effect of a gradual GC withdrawal scheme on the flare rate among SLE patients with sustained clinical remission.

Methods: SLE patients who received prednisolone 5 mg/day for at least 4 weeks and had clinical SLE Disease Activity Index-2000 (cSLEDAI-2K) = 0 for a minimum of 6 months were recruited. The participants were randomly assigned in a 1:1 ratio to either the 16-week gradual discontinuation of prednisolone (withdrawal group) or continuation of prednisolone for 24 weeks (maintenance group) with a planned enrolment of 36. The primary outcome was the proportion of patients experiencing a flare, defined with either change of cSLEDAI-2K ≥ 4, SLE-Disease Activity Score ≥ 1.72 or any treatment escalation over 24 weeks.

Results: Twenty patients were assigned to the maintenance group (10 patients), and the withdrawal group (10 patients). The flare rate was higher in the withdrawal group compared with the maintenance group (3 vs. 1 patient; HR 3.57; 95% CI 0.37 to 34.51, p = 0.24). All patients who experienced a flare were serologically active clinically quiescent at screening. Adverse events (AEs) occurred more in the withdrawal group (7 vs. Two patients). The trial was terminated early due to the occurrence of flares and AEs.

Conclusion: Gradual tapering of 5 mg/day of prednisolone showed non-significant higher rate of relapse and AEs in SLE patients with clinical remission.

Clinical trial number: The trial was registered with ClinicalTrials.gov, NCT06234852.