Lupus & antiphospholipid syndrome
Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study
Primary result · BICLA responseResult — go to the resultBICLA response difference 15.5% 95% CI 2.3–28.6Authors' conclusion
Consistent with the well-established profile of intravenous anifrolumab, subcutaneous anifrolumab demonstrated significant, clinically meaningful treatment benefits when added to standard therapy, and an acceptable safety profile in patients with moderate to severe SLE.
Study context
- Population
- Adults with moderate to severe systemic lupus erythematosus (SLE) activity despite standard therapyfull analysis
- Participants
- 367 adults
- Comparison
- SC anifrolumab 120 mg once weekly vs placebo for 52 weeks, added to standard therapy
- Anifrolumabn = 184
- Placebon = 183reference
- Primary endpoint
- Treatment difference in BICLA response
- Follow-up
- 52 weeks
Methodological detailsmultinational, phase 3, double-blind, placebo-controlled, 1:1 randomization, preplanned interim analysis
- Multinational
- Phase 3
- Double-blind
- Placebo-controlled
- 1:1 randomization
- Preplanned interim analysis
Primary result
BICLA response
BICLA response difference
15.5%
95% CI 2.3–28.6
P = 0.0211
By group
Anifrolumabvs Placebo
BICLA response difference 15.5% (95% CI 2.3–28.6); P = 0.0211
As reported in the abstract
Further findings
| Outcome | Anifrolumab | Placebo | Estimate | P value | |
|---|---|---|---|---|---|
| BICLA response while maintaining low/reduced oral GC doses · week 52Full analysis | 56.2% | 34.0% | difference 22.3% (95% CI 12.3–32.2) | P < 0.0001 | |
| DORIS remission · week 52 | treatment difference 14.2% (95% CI 5.6–22.8) | P = 0.0012 | |||
| LLDAS attainment · week 52 | treatment difference 14.1% (95% CI 4.6–23.6) | P = 0.0038 | |||
| −2002040Difference (linear scale) |
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Time to first sustained BICLA response | 2.2 (1.5–3.2) | P < 0.0001 | |
| 0.20.5125Hazard ratio (log scale) |
Safety
Serious adverse events
Herpes zoster
Original publication
Efficacy and Safety of Subcutaneous Anifrolumab in Systemic Lupus Erythematosus: A Randomized, Phase 3 Study. Arthritis Rheumatol. Published 17 February 2026. doi:10.
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