- In patients with active systemic lupus erythematosus (SLE), the TULIP-2 phase 3 trial showed that anifrolumab yields a better response than placebo on a week 52 composite outcome.
- This primary outcome was a secondary outcome in a previous, unsuccessful TULIP-1 trial with a different primary outcome.
- Anifrolumab is a human monoclonal antibody to type 1 interferon receptor subunit 1.
Why this matters
- Findings may be used to gain regulatory approval.
- Randomized, double-blind, placebo-controlled, parallel-group phase 3 trial (n=362) of monthly intravenous anifrolumab.
- The primary outcome, response at week 52 to the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA), which covers 6 outcomes including:
- Reduction in any moderate to severe baseline disease activity and no worsening in any of 9 organ systems in the BILAG index.
- No worsening on the SLE Disease Activity Index.
- Funding: AstraZeneca.
- Anifrolumab had a better BICLA response rate than placebo (47.8% vs 31.5%, respectively; difference, 16.3 [95% CI, 6.3-26.3] percentage points).
- The subgroup with a high interferon gene signature also had a better anifrolumab response (48.0% vs 30.7% in the placebo group).
- Anifrolumab was also beneficial in several secondary outcomes.
- Herpes zoster (7.2%) and bronchitis (12.2%) were common anifrolumab-related adverse events.
- Trial was not designed to test durability of response past 52 weeks.