The European Commission approves self-administered subcutaneous anifrolumab for adult patients with SLE

The European Commission (EC) has approved subcutaneous (SC) self-administration of anifrolumab as a pre-filled pen for adult patients with systemic lupus erythematosus (SLE), on top of standard therapy.¹

The approval is based on positive results from the phase III, randomized, double-blind TULIP-SC trial (NCT04877691), which assessed the efficacy and safety of SC administration of anifrolumab vs placebo in participants aged 18–70 years with moderate-to-severe, active, autoantibody-positive SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants).¹ In this patient population, SC administration of anifrolumab led to a clinically meaningful reduction in disease activity compared with placebo.¹

Key data from an interim analysis of the TULIP-SC trial²

• The primary endpoint was met; 59.4% of patients achieved a British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) response at Week 52 with anifrolumab (n = 109) vs 43.9% patients with placebo (n = 111; p = 0.0211).
• The incidence of any adverse events (AEs) was 74.4% with anifrolumab vs 71.2% with placebo; any AE of severe intensity was 7.4% with anifrolumab vs 4.7% with placebo.
• Injection site reactions occurred in 15.3% and 17.1% of patients receiving anifrolumab and placebo, respectively.

Anifrolumab, as an intravenous infusion administered by a healthcare provider, has already been approved by the U.S. Food and Drug Administration (FDA) in 2021 and by the EC in 2022 for the treatment of moderate-to-severe SLE.^3,4 The approval of a self-administered formulation has the potential to make treatment more convenient for patients.¹