Lupus & antiphospholipid syndrome
Long-Term Safety and Effectiveness of Tacrolimus in Patients With Lupus Nephritis in Japan: 10-Year Analysis of the Real-World TRUST Study
Authors' conclusion
Tacrolimus was effective and generally well tolerated as maintenance therapy for LN in a large cohort of patients in Japan followed for 10 years, almost half of whom remained on therapy for the entire duration of follow-up.
Study context
- Population
- Patients with lupus nephritis (LN) receiving maintenance tacrolimus in real-world clinical settings, 278 institutions across Japan, followed 10 years1,355 with safety data
- Participants
- 1,395 patients
- Outcome
- Tacrolimus continuation and cumulative outcome rates (Kaplan-Meier)
- Follow-up
- Year 10
Methodological detailsopen-label, noncomparative, observational, multicentre (278 medical institutions), Kaplan-Meier analysis
- Open-label
- Noncomparative
- Observational
- Multicentre (278 medical institutions)
- Kaplan-Meier analysis
Main finding
As reported in the abstract
Remained on tacrolimus for the full 10 years
49.3%
Cumulative relapse rate
44.5%
Cumulative renal failure rate
12.2%
Cumulative dialysis rate
4.5%
Observational data: associations, not effects.
Further findings
Mean daily oral GC dose · 4 weeks after tacrolimus initiation to year 10
- Significant reduction
- P < 0.001
- Mean (SD) at 4 weeks: 16.0 (9.7) mg/day
- Mean (SD) at year 10: 7.2 (4.4) mg/day
Renal function · 10 years
- Generally well maintained over the 10 years of follow-up
Safety
Serious adverse drug reactions (ADRs): infections (most frequently reported serious ADRs)
- Infections, n (%) of patients
- 131 [9.7%]
- Safety population n = 1355
Other ADRs over time (incl. renal impairment, malignant tumors, cardiac dysfunction) · 10 years
- Except for infections, no marked increase in the incidence of any other ADRs over time
Original publication
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