Lupus & antiphospholipid syndrome
Time to onset of clinical response to anifrolumab in patients with SLE: pooled data from the phase III TULIP-1 and TULIP-2 trials
Authors' conclusion
Anifrolumab treatment was associated with sustained improvements in overall SLE disease activity and skin responses versus placebo from Week 8, which likely led to greater glucocorticoid reductions in the anifrolumab versus placebo groups from Week 20.
Study context
- Population
- Patients with moderate-to-severe SLE receiving standard therapypooled TULIP-1 and TULIP-2
- Participants
- 726 patients
- Comparison
- Anifrolumab 300 mg IV every 4 weeks for 48 weeks vs placebo, with standard therapy
- Anifrolumab 300 mgn = 360
- Placebon = 366reference
- Outcome
- BICLA response over time
Methodological detailsphase III, 52-week, placebo-controlled, nominal p values
- Phase III
- 52-week
- Placebo-controlled
- Nominal p values
Pooled result
As reported in the abstract
from Week 8
- Anifrolumab 300 mg vs Placebo: P < 0.001
- All p values nominal
Further pooled results
| Outcome | HR (95% CI) | |
|---|---|---|
| BICLA response sustained to Week 52 | 1.73 (1.37–2.20) | |
| CLASI-A skin response sustained to Week 52 · as early as Week 8 | 1.72 (1.17–2.55) | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | P value |
|---|---|
| SRI(4) response over time · from Week 12More patients with SRI(4) response from Week 12 | P = 0.005 |
| GC dosage reduction from baseline · from Week 20 through Week 52Greater reductions with anifrolumab from Week 20 | P = 0.010 |
Original publication
Time to onset of clinical response to anifrolumab in patients with SLE: pooled data from the phase III TULIP-1 and TULIP-2 trials. Lupus Sci Med. Published 13 January 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →