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OBJECTIVE: Systemic lupus erythematosus (SLE) is a heterogeneous disease in which patient demographic and clinical characteristics correlate with disease severity and response to treatment
.
Anifrolumab , a human monoclonal antibody that binds to type I interferon receptor subunit 1 , has demonstrated efficacy and an acceptable safety profile in patients with moderate-to-severe SLE in Phase III clinical trials .
OBJECTIVE: Systemic lupus erythematosus (SLE) is a heterogeneous disease in which patient demographic and clinical characteristics correlate with disease severity and response to treatment
Methods: We performed a post hoc analysis of pooled data from the 52 - week phase III TULIP-1/TULIP-2 placebo-controlled trial of intravenous anifrolumab in patients withmoderate-to-severe SLE .
Outcomes were assessed in predefined subgroups: IFNGS (high / low), age, sex, body mass index, ethnicity, geographic region, age at onset, glucocorticoid use, disease activity, and serological markers .
RESULTS: In pooled data, patients received anifrolumab 300 mg (360/726) or placebo (366/726) ; 82.
6% were IFNGS high
RESULTS: In pooled data, patients received anifrolumab 300 mg (360/726) or placebo (366/726) ; 82.
6% were IFNGS high
Conclusions: Overall, this study supports the consistent efficacy and safety of anifrolumab in a range of patients with moderate to severe SLE .
In a few subgroups, the small sample size limited consistent efficacy and safety among patients .
Conclusions on whether anifrolumab treatment is beneficial .
Source: Vital EM, Merrill JT, Morand EF , et al.
Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials.
Annals of the Rheumatic Diseases Published Online First: 25 March 2022.
doi: 10.
Vital EM, Merrill JT, Morand EF , et al.
, et al.
Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials.
Annals of the Rheumatic Diseases Annals of the Rheumatic Diseases Published Online First: 25 March 2022.
doi: 10.
1136/annrheumdis-2021-221425 Leave a comment here
