Lupus & antiphospholipid syndrome
Effectiveness and safety of tacrolimus in systemic lupus erythematosus with various clinical manifestations: a retrospective real-world study
Authors' conclusion
Tacrolimus demonstrated effectiveness in reducing disease activity, enabling significant glucocorticoid tapering, and inducing multi-organ remission in extrarenal manifestations.
Study context
- Population
- Systemic lupus erythematosus (SLE) patients in the CSTAR cohort, mostly mild, non-new-onset disease84.39% mild disease
- Participants
- 679 patients
- Outcome
- SLEDAI-2K
- Follow-up
- Week 48
Methodological detailsreal-world, single-arm
- Real-world
- Single-arm
Main finding
As reported in the abstract
Baseline
3.3
± 4.1
Week 48
1.7
± 2.2
P < 0.001
Observational data: associations, not effects.
Secondary outcomes
Daily GC dose · week 48 · significant decrease
P < 0.001
SRI-4 response · weeks 4, 24 and 48
- Week 4
- 59.06% (75/127)
- Week 24
- 49.15% (58/118)
- Week 48
- 48.75% (39/80)
Physician Global Assessment (PGA) scores
- Statistically significant reduction in PGA scores
- P < 0.001
Organ remission rates ≥ 50%
- Mucocutaneous
- 78.95% [45/57]
- Serositis
- 88.89% [8/9]
- Arthritis
- 82.61% [19/23]
- Leukopenia
- 71.87% [23/32]
Safety
Adverse events
- Any AE
- 7.36% (50/679)
- Treatment-related AE
- 0.74% (5/679)
Serious AEs
- Serious AEs (rare)
- 3
- Treatment-related serious AEs
- 0
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Effectiveness and safety of tacrolimus in systemic lupus erythematosus with various clinical manifestations: a retrospective real-world study. Arthritis Res Ther. Published 27 October 2025. doi:10.
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