Lupus & antiphospholipid syndrome
Immunosuppressant withdrawal versus glucocorticoid withdrawal in SLE: 2-year outcomes of a noninferiority randomized controlled trial
Primary result · Flare (SFI)Result — go to the resultRisk difference −10.6% 95% CI −26.5 to 5.1Authors' conclusion
IS withdrawal is noninferior to GC withdrawal in SLE patients in long-term clinical remission.
Study context
- Population
- Patients aged >18 with SLE on stable glucocorticoid (GC) (prednisolone ≤7.5 mg/day) and maintenance non-biological immunosuppressant (IS) for ≥3 years, in clinical remission for ≥1 year117 in primary analysis
- Participants
- 121 patients
- Comparison
- IS withdrawal vs GC withdrawal
- IS withdrawaln = 59
- GC withdrawaln = 58reference
- Primary endpoint
- Proportion of patients experiencing a flare (SELENA-SLEDAI Flare Index)
- Follow-up
- 52 weeks
Methodological detailsopen-label, single-centre, 1:1 randomisation, non-inferiority
- Open-label
- Single-centre
- 1:1 randomisation
- Non-inferiority
Primary result
Flare (SFI)
Risk difference
−10.6%
95% CI −26.5 to 5.1
P = 0.18
By group
IS withdrawalvs GC withdrawal
risk difference −10.6% (95% CI −26.5 to 5.1); P = 0.18
As reported in the abstract
Further findings
| Outcome | IS withdrawal | GC withdrawal | Risk difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Flare at maximum follow-up · maximum follow-up (2 years)Noninferiority of IS withdrawal at 2 years confirmed | 32.2% | 44.8% | −12.6% (−30.1 to 4.9) | P = 0.11 | |
| −40−20020Difference (linear scale) |
Damage accrual · 52 weeks and maximum follow-up
- Similar between the two groups at both endpoints
Original publication
Immunosuppressant withdrawal versus glucocorticoid withdrawal in SLE: 2-year outcomes of a noninferiority randomized controlled trial. Rheumatology (Oxford). Published 24 March 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →