Real-world effectiveness of belimumab and anifrolumab in systemic lupus erythematosus: comparable trends in disease activity and glucocorticoid reduction

Immunol Med. 2025 Dec;48(4):371-380. doi: 10.1080/25785826.2025.2528296. Epub 2025 Jul 8.

Abstract

Despite the proven efficacy of belimumab and anifrolumab for SLE, their relative effectiveness remains uncertain owing to conflicting indirect comparison studies. We conducted a comparative effectiveness study using multicenter health records to evaluate the adjusted 12-month changes in the SLE Disease Activity Index 2000 (SLEDAI-2K), glucocorticoid dose, anti-DNA antibody titers, and CH50 levels, along with the adjusted hazard ratios of discontinuation and adverse events. A total of 58 bionaïve lupus patients (belimumab: 36, anifrolumab: 22) who initiated belimumab or anifrolumab on or after January 1, 2022 were identified and followed for up to 2 years. Adjusted changes in the SLEDAI-2K, glucocorticoid dose, and anti-DNA antibody titers were similar, with between-group differences (belimumab - anifrolumab) of -0.4 SLEDAI-2K units (95% CI: -4.8, 4.0), 1.4 mg/day (95% CI: -5.1, 7.9), and -2.7 IU/mL (95% CI: -27, 21), respectively. Belimumab was associated with a greater increase in adjusted CH50 levels (between-group difference: 5.3 CH50/mL, 95% CI: -8.9, 20) and a lower adjusted hazard ratio of discontinuation (0.68, 95% CI: 0.12, 3.7). Infection was the most common adverse event (belimumab: 31%, anifrolumab: 41%). Our findings suggest both treatments provide similar effectiveness, with belimumab offering potential benefits in CH50 levels, treatment continuity, and infection risk.

Keywords: Systemic lupus erythematosus; anifrolumab; belimumab; comparative effectiveness.

Publication types

  • Multicenter Study
  • Comparative Study

MeSH terms

  • Adult
  • Antibodies, Antinuclear / blood
  • Antibodies, Monoclonal, Humanized* / adverse effects
  • Antibodies, Monoclonal, Humanized* / therapeutic use
  • Female
  • Glucocorticoids* / administration & dosage
  • Glucocorticoids* / therapeutic use
  • Humans
  • Immunosuppressive Agents* / adverse effects
  • Immunosuppressive Agents* / therapeutic use
  • Lupus Erythematosus, Systemic* / diagnosis
  • Lupus Erythematosus, Systemic* / drug therapy
  • Lupus Erythematosus, Systemic* / immunology
  • Male
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • belimumab
  • Antibodies, Monoclonal, Humanized
  • Glucocorticoids
  • anifrolumab
  • Immunosuppressive Agents
  • Antibodies, Antinuclear