Lupus & antiphospholipid syndrome
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
Authors' conclusion
GC withdrawal may be feasible in sustained clinically inactive SLE patients. HCQ maintenance can exert a protective role in preventing disease relapse after GC withdrawal.
Study context
- Population
- Systemic lupus erythematosus (SLE) patients with sustained clinically inactive disease maintained on low-dose glucocorticoid (GC) plus hydroxychloroquine (HCQ), Chinaper-protocol analysed
- Participants
- 333 patients
- Comparison
- GC withdrawal with or without HCQ maintenance vs continued GC plus HCQ
- Primary endpoint
- Proportion of patients with relapse (SELENA-SLEDAI flare index)
- Follow-up
- 33 weeks
Methodological detailsopen-label, multicentre, three-arm, non-inferiority, 3 November 2016 to 13 August 2021
- Open-label
- Multicentre
- Three-arm
- Non-inferiority
- 3 November 2016 to 13 August 2021
Primary result
As reported in the abstract
Relapse
Each group vs dual maintenanceRelapse rate difference (95% CI)P value
Drug-freefailed to achieve non-inferiority
21.4%(12.3%–30.5%)
P = 0.238for non-inferiorityHCQachieved non-inferiority
6.5%(−0.5% to 13.5%)
P = 0.034for non-inferiorityFurther findings
| Outcome | P value |
|---|---|
| Relapse, HCQ vs drug-freeFewer relapses with HCQ | P = 0.006 |
Safety
Adverse events
- Similar among all three groups
Original publication
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. Published 2 January 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →