SLE: anifrolumab tops placebo in redesigned phase 3 TULIP-2

  • Morand EF & al.
  • N Engl J Med
  • 18/12/2019

  • Miriam Davis, PhD
  • Clinical Essentials
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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.

Limitation

  • Trial was not designed to test durability of response past 52 weeks.