Lupus & antiphospholipid syndrome
Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials
Authors' conclusion
This post hoc analysis of pooled TULIP-1/TULIP-2 data supports the efficacy and tolerability of anifrolumab in patients with moderate-to-severe SLE regardless of IS treatment history.
Study context
- Population
- Patients with moderate-to-severe systemic lupus erythematosus (SLE) in the phase 3 TULIP-1 and TULIP-2 trials257 immunosuppressants (IS)-inexperienced, 469 IS-experienced
- Participants
- 127 / 130 / 233 / 236
- Comparison
- IV anifrolumab 300 mg vs placebo alongside standard therapy, by reported IS use
- Anifrolumab 300 mg, IS-inexperiencedn = 127
- Placebo, IS-inexperiencedn = 130reference
- Anifrolumab 300 mg, IS-experiencedn = 233
- Placebo, IS-experiencedn = 236reference
- Primary endpoint
- Definition of Remission in SLE (DORIS) remission and Lupus Low Disease Activity State (LLDAS) attainment by IS use
- Follow-up
- Week 52
Methodological detailspooled data, phase 3, subgroup analysis by IS use, stratified Cochran-Mantel-Haenszel approach, all p values nominal
- Pooled data
- Phase 3
- Subgroup analysis by IS use
- Stratified Cochran-Mantel-Haenszel approach
- All p values nominal
Primary result
As reported in the abstract
DORIS remission
Anifrolumab 300 mg, IS-inexperienced vs Placebo, IS-inexperienced: P = 0.0242 · Anifrolumab 300 mg, IS-experienced vs Placebo, IS-experienced: P = 0.0304
Further findings
LLDAS attainment · Week 52 — Anifrolumab 300 mg, IS-inexperienced vs Placebo, IS-inexperienced · all p values are nominal
P = 0.1718
| Outcome | P value |
|---|---|
| LLDAS attainment · Week 52Anifrolumab 300 mg, IS-experienced vs Placebo, IS-experienced · all p values are nominal | P = 0.0038 |
Safety
Safety (summarised descriptively)
- Anifrolumab well tolerated regardless of reported IS history; safety more favourable among IS-inexperienced vs IS-experienced patients
Original publication
Efficacy and safety of anifrolumab in patients with systemic lupus erythematosus without prior immunosuppressant use: post hoc analysis of phase 3 TULIP-1 and TULIP-2 trials. Lupus Sci Med. Published 8 April 2026. doi:10.
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