Lupus & antiphospholipid syndrome
Comparative study of adverse drug reactions associated with anifrolumab and belimumab for the treatment of systemic lupus erythematosus
Main finding · Herpes zosterResult — go to the resultROR 5.13 95% CI 3.97–6.62Authors' conclusion
Anifrolumab and belimumab exhibit distinct safety profiles. Anifrolumab carries a significantly higher risk of herpes zoster infection, warranting pre-treatment vaccination assessment. Belimumab shows a predominance of administration-related and non-serious events.
Study context
- Population
- Individual Case Safety Reports for Systemic Lupus Erythematosus (SLE) in the FDA Adverse Event Monitoring System (AEMS), January 1, 2011 to March 30, 2026Individual Case Safety Reports (ICSRs)
- Participants
- 2,124 vs 30,107
- Exposure
- Anifrolumab vs belimumab
- Anifrolumabn = 2,124
- Belimumabn = 30,107reference
- Outcome
- Adverse drug reactions (ADRs) by disproportionality analysis (ROR with 95% CI)
Methodological detailsdisproportionality analysis, FDA Adverse Event Monitoring System (AEMS), MedDRA version 28.1 Preferred Terms
- Disproportionality analysis
- FDA Adverse Event Monitoring System (AEMS)
- MedDRA version 28.1 Preferred Terms
Main finding
Herpes zoster
Reporting Odds Ratio (ROR)
5.13
95% CI 3.97–6.62
P < 0.0001
Anifrolumabvs Belimumab
ROR 5.13 (95% CI 3.97–6.62); P < 0.0001
As reported in the abstract
Observational data: associations, not effects.
Original publication
Comparative study of adverse drug reactions associated with anifrolumab and belimumab for the treatment of systemic lupus erythematosus. Lupus. Published 1 June 2026. doi:10.
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