Lupus & antiphospholipid syndrome
Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial
Authors' conclusion
Over 4 years of treatment, patients reported improvements in health status and health-related quality of life, including differences favouring anifrolumab compared with placebo.
Study context
- Population
- Patients with moderate-to-severe systemic lupus erythematosus (SLE) receiving standard therapy who completed TULIP-1 or TULIP-2 and entered the 3-year extensionmodified ITT
- Participants
- 369 patients
- Comparison
- Anifrolumab 300 mg every 4 weeks vs placebo, with standard therapy, for up to 4 years
- Anifrolumabn = 257
- Placebon = 112reference
- Primary endpoint
- Exploratory: changes from baseline in patient-reported outcomes (SF-36v2 (acute), PGA, EQ-5D-5L, WPAI-Lupus) and health utility indices (SF-6D, EQ-5D-5L)
- Follow-up
- Up to week 208
Methodological detailslong-term extension, double-blind, placebo-controlled, phase 3, long-term extension of TULIP-1 and TULIP-2, exploratory analysis
- Long-term extension
- Double-blind
- Placebo-controlled
- Phase 3
- Long-term extension of TULIP-1 and TULIP-2
- Exploratory analysis
Primary result
As reported in the abstract
SF-36v2 (acute) improvement from baseline · week 208
Each group vs placeboEstimate (95% CI)
Anifrolumab
least-squares mean difference (bodily pain domain) 5.9(−0.7 to 12.5)
Anifrolumab
least-squares mean difference (mental health domain) 3.7(−1.2 to 8.6)
Further findings
| Outcome | Least-squares mean difference (95% CI) | |
|---|---|---|
| SF-6D improvement from baseline · week 24 | 0.013 (−0.007 to 0.032) | |
| SF-6D improvement from baseline · week 208 | 0.016 (−0.010 to 0.042) | |
| −0.0200.020.040.06Difference (linear scale) |
Original publication
Long-term effect of anifrolumab on patient-reported outcomes in systemic lupus erythematosus (TULIP-LTE): a randomised, placebo-controlled, phase 3 long-term extension trial. Lancet Rheumatol. Published 2 May 2025. doi:10.
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