ArticleArthritis research & therapy2025
Effectiveness and safety of tacrolimus in systemic lupus erythematosus with various clinical manifestations: a retrospective real-world study.
Article in Arthritis research & therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Calcineurin Inhibitors: Current Role, Toxicity Management, and Future Frontiers in Immunosuppression.Molecular neurobiology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study evaluated the real-world effectiveness and safety of tacrolimus as a steroid-sparing maintenance therapy alone without additional biologics or immunosuppressive medications in systemic lupus erythematosus (SLE), particularly in mild, non–new-onset cases, with a focus on glucocorticoid-sparing effects and multi-organ remission.
methodsA retrospective analysis was conducted using data from 679 SLE patients in the Chinese SLE Treatment and Research Group (CSTAR) cohort. Patients received tacrolimus for ≥ 4 weeks alongside glucocorticoids and/or hydroxychloroquine were included. Patients on other immunosuppressants or biologics at baseline were excluded. The primary endpoint was the changes in SLE Disease Activity Index 2000 (SLEDAI-2 K). Secondary endpoints included SLE Responder Index-4 (SRI-4) response at weeks 4, 24, and 48 (≥ 4-point SLEDAI-2 K reduction with no new major flare), Physician Global Assessment (PGA) scores, remission of organ-specific disease manifestations, reduction in daily glucocorticoid dose, and safety.
resultsAt baseline, 84.39% (573/679) of patients had mild disease (SLEDAI-2 K ≤ 6), 11.49% (78/679) moderate, and 4.12% (28/679) severe. Statistically significant reductions in SLEDAI-2 K (baseline: 3.3 ± 4.1; week 48: 1.7 ± 2.2, p < 0.001) and PGA scores (p < 0.001) were observed. Glucocorticoid doses significantly decreased from 20.0 ± 18.3 mg/day (baseline, n = 590) to 10.0 ± 9.9 mg/day (week 48, n = 233; p < 0.001). SRI-4 response rates were 59.06% (75/127), 49.15% (58/118), and 48.75% (39/80) at weeks 4, 24, and 48, respectively. Organ remission rates ≥ 50% were achieved for mucocutaneous (78.95% [45/57]), serositis (88.89% [8/9]), arthritis (82.61% [19/23]), and leukopenia (71.87% [23/32]). Adverse events occurred in 7.36% (50/679) of patients, with only 0.74% (5/679) deemed treatment-related; serious AEs were rare (n = 3, none treatment-related).
conclusionTacrolimus demonstrated effectiveness in reducing disease activity, enabling significant glucocorticoid tapering, and inducing multi-organ remission in extrarenal manifestations. Its favorable safety profile supports its use as a promising sparing maintenance therapy alone, potentially obviating the need for additional biologic or immunosuppressive agents in SLE.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.