Lupus & antiphospholipid syndrome

Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study

J RheumatolPublished Retrospective cohort study

Authors' conclusion

This study provides real-world experience on the use of ANI in patients with refractory SLE, confirming its rapid effectiveness and an overall acceptable safety profile.

Study context

Population
Adults with active refractory systemic lupus erythematosus (SLE), 9 Italian SLE referral centres in a compassionate use program
Participants
26 adults
Outcome
Disease activity change from baseline
Follow-up
4 weeks
Methodological detailsmulticentre, real-world, compassionate use program
  • Multicentre
  • Real-world
  • Compassionate use program

Main finding

As reported in the abstract

Significant decrease in SLEDAI-2K
P = 0.01
Significant decrease in SLE-Disease Activity Score
P = 0.01
Significant decrease in PGA
P = 0.001

Observational data: associations, not effects.

Further findings

CLE Disease Area and Severity Index-activity

Significant reduction
P < 0.001

Tender and swollen joint counts

Tender joint count, significant reduction
P = 0.03
Swollen joint count, significant reduction
P = 0.02

Remission and Lupus Low Disease Activity State (LLDAS) · 3 months

Remission
33%
LLDAS
46%

Remission and LLDAS · 6 months

Remission
50%
LLDAS
80%

Nonresponders · at least 24 weeks of follow-up

Nonresponders among patients with at least 24 weeks of follow-up
20%
  • 4/20 patients with at least 24 weeks of follow-up

Mean daily glucocorticoid (GC) dose · from week 4

Significant reduction
P = 0.04

Safety

OutcomeValues
Disease flares (SELENA-SLEDAI)ANI 4 events
Disease flares (SELENA-SLEDAI) — Mild-moderate flares
3
Disease flares (SELENA-SLEDAI) — Severe flares
1

Original publication

Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study. J Rheumatol. Published 1 July 2024. doi:10.3899/jrheum.2024-0053

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