Lupus & antiphospholipid syndrome
A Randomized, Placebo‐Controlled Phase III Extension Trial of the Long‐Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus
Authors' conclusion
No new safety findings were identified in the LTE study
Study context
- Population
- Patients with active systemic lupus erythematosus (SLE) who completed a TULIP trial and enrolled in the long-term extension (LTE) study
- Comparison
- Anifrolumab 300 mg vs placebo every 4 weeks, throughout TULIP and LTE
- Primary endpoint
- Long-term safety and tolerability (serious adverse events (SAEs), exposure-adjusted incidence rates (EAIRs) per 100 patient-years)
- Follow-up
- 3 years
Methodological detailsphase III, long-term extension, blinded, placebo-controlled, 3-year
- Phase III
- Long-term extension
- Blinded
- Placebo-controlled
- 3-year
Primary result
As reported in the abstract
SAEs, EAIR per 100 patient-years
Further findings
- Anifrolumab associated with lower cumulative GC use and greater mean improvement in SLEDAI-2K vs placebo
Safety
AEs leading to treatment discontinuation, EAIR
Non-opportunistic serious infections, EAIR
Exposure-adjusted event rate
| Outcome | Anifrolumab | Placebo |
|---|---|---|
| COVID-related AEs incl. asymptomatic infections, exposure-adjusted event rate | 15.5 | 9.8 |
Non-opportunistic serious infections, EAIR
- Comparable between groups
COVID-related AEs incl. asymptomatic infections, exposure-adjusted event rate
- No COVID-related AEs in fully vaccinated individuals
Malignancy and major acute CV events, EAIR
- Low and comparable between groups
Original publication
A Randomized, Placebo‐Controlled Phase III Extension Trial of the Long‐Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus. Arthritis Rheumatol. Published 11 November 2022. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →