A RECENT multicentre trial in China has highlighted the protective role of hydroxychloroquine (HCQ) in reducing relapse risk for patients with systemic lupus erythematosus (SLE) after glucocorticoid (GC) withdrawal. The PRESS study, a 33-week randomised controlled trial, evaluated the safety of discontinuing low-dose GC therapy in patients with sustained inactive SLE and explored the role of HCQ in maintaining disease stability.
The trial enrolled 333 patients with clinically inactive SLE who were receiving low-dose GC and HCQ therapy. Participants were randomly assigned to one of three groups: a drug-free group (both GC and HCQ withdrawn), an HCQ group (GC discontinued but HCQ maintained), and a dual maintenance group (both GC and HCQ continued). The primary outcome was the relapse rate within 33 weeks, assessed by the SLE Disease Activity Index flare index.
The results revealed relapse rates of 26.1% in the drug-free group, 11.2% in the HCQ group, and 4.7% in the dual maintenance group. The HCQ group demonstrated non-inferiority to the dual maintenance group, with a relapse rate difference of 6.5% (95% CI −0.5% to 13.5%; P = 0.034). In contrast, the drug-free group did not achieve non-inferiority, with a significantly higher relapse rate difference of 21.4% (95% CI 12.3% to 30.5%). Furthermore, the HCQ group had significantly fewer relapses than the drug-free group (P = 0.006). Adverse event rates were comparable across all groups.
The findings suggest that GC withdrawal is feasible for patients with sustained inactive SLE, particularly when HCQ therapy is maintained. HCQ appears to offer substantial protection against disease relapses, making it a valuable tool in reducing long-term steroid dependency.
Reference
Fei Y et al. Evaluation and prediction of relapse risk in stable systemic lupus erythematosus patients after glucocorticoid withdrawal (PRESS): an open-label, multicentre, non-inferiority, randomised controlled study in China. Ann Rheum Dis. 2024;DOI: 10.1136/ard-2024-225826.
