Lupus & antiphospholipid syndrome
Lupus low disease activity state attainment in the phase 3 TULIP trials of anifrolumab in active systemic lupus erythematosus
An erratum to this article was published (Ann Rheum Dis, 11 Apr 2024 ↗)
Pooled result · LLDAS attainmentResult — go to the resultOdds ratio 1.8 95% CI 1.3–2.5Authors' conclusion
LLDAS attainment was highly associated with, but more stringent than, BICLA and SRI(4) responses. Compared with placebo, anifrolumab treatment was associated with earlier, more frequent, and more prolonged and sustained LLDAS.
Study context
- Population
- Patients with moderate to severe systemic lupus erythematosus (SLE) receiving standard therapy
- Participants
- 819 patients
- Comparison
- Anifrolumab vs placebo, with standard therapy
- Outcome
- LLDAS attainment (SLEDAI-2K ≤4 without major organ activity, no new disease activity, PGA ≤1, prednisone ≤7.5 mg/day, no non-standard immunosuppressant dosing)
- Follow-up
- Week 52
Methodological detailsphase 3, Cox regression, logistic regression
- Phase 3
- Cox regression
- Logistic regression
Pooled result
LLDAS attainment
Odds ratio
1.8
95% CI 1.3–2.5
P = 0.0011
By group
As reported in the abstract
Further pooled results
| Outcome | Anifrolumab | Placebo | Estimate | P value | |
|---|---|---|---|---|---|
| Time to first LLDAS attainmentCox regression; earlier LLDAS attainment with anifrolumab | HR for first LLDAS attainment 1.76 (95% CI 1.35–2.30) | P < 0.0001 | |||
| DORIS remission · week 52Higher remission rates with anifrolumab | 15.3% | 7.6% | OR for attaining DORIS remission 2.2 (95% CI 1.4–3.6) | P = 0.0013 | |
| 0.20.5125Ratio (log scale) |
- Cumulative time in lupus low disease activity state (LLDAS) · increased cumulative time in LLDAS with anifrolumab
- P < 0.0001
- Sustained LLDAS · higher likelihood of sustained LLDAS with anifrolumab
- P < 0.001
LLDAS attainment, all patients agnostic to treatment · week 52
- Attained LLDAS
- 205/819 (25.0%)
- LLDAS-attainers who were also BICLA responders
- 186/205 (90.7%)
- Post hoc analysis, pooled TULIP-1 and TULIP-2
LLDAS attainment among BICLA responders and SRI(4) responders · week 52
- BICLA responders attaining LLDAS
- 186/318 (58.5%)
- SRI(4) responders attaining LLDAS
- 203/380 (53.4%)
Improvement from baseline in patient global assessment, LLDAS-attainers vs non-attainers · week 52
- Improvements threefold greater in LLDAS-attainers
Original publication
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