Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.

The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.

This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.

Inclusion Criteria:

• Aged; 20 years
• Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.
• Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
• Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.

Exclusion Criteria:

• Pregnant or pregnancy planning
• Unable to follow the schedules
• Overlap with other autoimmune disease, except secondary SjS and APS
• Co-morbid with any other condition which required prednisolone treatment
• Documented adrenal insufficiency