Interferon Inhibition With Anifrolumab Reduces Disease Activity in Systemic Lupus Erythematosus

Anifrolumab, a type 1 interferon receptor inhibitor, was associated with significant reduction in disease activity in patients with systemic lupus erythematosus (SLE), according to study results presented at the European League Against Rheumatism (EULAR) 2020 E-Congress, held online from June 3 to 6, 2020.

Investigators pooled data from separate phase 3 clinical trials, TULIP-2 and TULIP-1. Both trials evaluated the efficacy of intravenous anifrolumab vs placebo for the treatment of moderate to severe SLE. Eligible patients did not respond to standard of care treatment. Anifrolumab and placebo were administered every 4 weeks for 52 weeks. The primary outcome was treatment response, according to the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) tool.

Treatment response was defined by the following characteristics: reduction of baseline BILAG-2004 scores with no worsening in any organ system; no worsening of SLE Disease Activity Index 2000 (SLEDAI-2K) score; no worsening of  ≥0.3 points in the Physician’s Global Assessment; no trial treatment discontinuation; and no use of medications restricted by the trial. BICLA response rates were compared between the anifrolumab 300 mg and placebo groups.

In each trial, 180 patients received anifrolumab 300 mg; 182 and 184 patients received placebo in TULIP-2 and TULIP-1, respectively. Demographic and clinical characteristics were comparable between treatment and placebo arms.

In both trials, a greater proportion of the anifrolumab vs placebo arms achieved BICLA responses at week 52 (TULIP-2: 47.8% vs 31.5%; TULIP-1: 46.1% vs 29.6%). This trend persisted across disease severity strata. Among patients with SLEDAI-2K <10 points, the difference in response rates between anifrolumab and placebo arms was 15.3% and 16.9% for TULIP-2 and TULIP-1, respectively. Among patients with SLEDAI-2K ≥10 points, the same trend was observed, favoring anifrolumab (TULIP-2 difference, 16.7%; TULIP-1, 16.2%).

Anifrolumab also outperformed placebo across baseline oral corticosteroid use strata (prednisone or equivalent <10 mg/d [TULIP-2 difference, 20.1%; TULIP-1, 16.2%] vs ≥10 mg/d [TULIP-2, 12.0%; TULIP-1, 17.7%]). Anifrolumab continued to outperform placebo in analyses stratified by age, sex, race/ethnicity, age at disease onset, and anti-drug antibody status.

Robust BICLA response rates observed in the treatment groups of both TULIP-2 and TULIP-1 support the efficacy of anifrolumab for the treatment of SLE. The clinical benefits of anifrolumab persisted across age, sex, and disease severity strata. However, given the small number of patients in some subgroups, the results should be extrapolated with care.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Morand EF, Furie R, Tanaka Y, et al. Efficacy of anifrolumab in active systemic lupus erythematosus: patient subgroup analysis of BICLA response in 2 phase 3 trials. Presented at: EULAR 2020 E-Congress; June 3-6, 2020. Abstract OP0049.