Lupus & antiphospholipid syndrome
Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial
Authors' conclusion
The safety and tolerability profile through Year 2 of TULIP-LN was generally consistent with Year 1, with promising efficacy results for the anifrolumab IR regimen.
Study context
- Population
- Patients with active lupus nephritis (LN) who achieved at least partial renal response and a GC tapering target in Year 175 continued into Year 2
- Participants
- 147 patients
- Comparison
- Anifrolumab intensified regimen vs basic regimen vs placebo, IV every 4 weeks
- Intensified regimen (IR)n = 29
- Basic regimen (BR)n = 23
- Placebon = 23reference
Methodological detailsphase II, double-blind, placebo-controlled, second-year extension
- Phase II
- Double-blind
- Placebo-controlled
- Second-year extension
Primary result
As reported in the abstract
Complete renal response · Week 104
Further findings
- Complete renal response with sustained GC tapering · Week 104 — IR
- 25.0%
eGFR improvement
- Numerically larger improvements in both anifrolumab groups vs placebo
Safety
Serious AEs · Year 2
Events
| Outcome | IR | BR | Placebo |
|---|---|---|---|
| Discontinuation due to AE · Year 2 | 2 | — not stated in the abstract | 1 |
| Herpes zoster · Year 2 | 1 | 1 | — not stated in the abstract |
— not stated in the abstract
≥1 adverse event (AE) during Year 2 (all patients)
- Patients with ≥1 AE
- 72%
COVID-19 cases
- No COVID-19 cases reported
Original publication
Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial. Lupus Sci Med. Published 22 August 2023. doi:10.
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