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OBJECTIVE : In the anifrolumab (type I interferon receptor monoclonal antibody) systemic lupus erythematosus (SLE) trial program, there is a trial (TULIP-1) in which the BILAG - based Comprehensive Lupus Assessment (BICLA) anifrolumab response was superior to placebo treatment , but the SLE response index (SRI(4)) treatment did not differ significant.
Researchers from AstraZeneca investigated the degree of concordance between BICLA and SRI(4) in the anifrolumab trial to better understand the drivers of discordant results in the SLE tria.
Researchers from AstraZeneca investigated the degree of concordance between BICLA and SRI(4) in the anifrolumab trial to better understand the drivers of discordant results in the SLE tria.
METHODS : TULIP-1 , TULIP-2 (all Phase 3 ) and MUSE (Phase 2b ) were randomized, 52 - week trials of intravenous anifrolumab ( 300 mg every 4 weeks for 48 weeks; TULIP-1/TULIP- 2 : n=180 ; MUSE : n=99 ) or placebo ( TULIP-1 : n=184 , TULIP-2 : n=182 ; MUSE : n=102 .
Week 52 BICLA and SRI(4) outcomes were assessed for each patien.
Week 52 BICLA and SRI(4) outcomes were assessed for each patien.
RESULTS : The majority of patients (78% – 85%) had consistent BICLA and SRI(4) results ( Cohen's Kappa 6 – 7 , nominal p<001.
Dual BICLA/SRI(4) response rates were superior to placebo in TULIP-1 , TULIP-2 and MUSE (all nominal p ≤ 004 .
A discordant subgroup of TULIP-1 BICLA non-responders /SRI(4) responders was identified ( 40/364 , 11% of the TULIP-1 population ), with more patients receiving placebo ( n=28 ) than anifrolumab ( n=12.
In this subgroup, patients who received placebo had lower baseline disease activity, joint counts, and glucocorticoid reduction rates, and more patients who received placebo had an arthritic response than patients who received anifroluma.
Dual BICLA/SRI(4) response rates were superior to placebo in TULIP-1 , TULIP-2 and MUSE (all nominal p ≤ 004 .
A discordant subgroup of TULIP-1 BICLA non-responders /SRI(4) responders was identified ( 40/364 , 11% of the TULIP-1 population ), with more patients receiving placebo ( n=28 ) than anifrolumab ( n=12
In this subgroup, patients who received placebo had lower baseline disease activity, joint counts, and glucocorticoid reduction rates, and more patients who received placebo had an arthritic response than patients who received anifroluma.
CONCLUSIONS : Across all trials, the majority of patients had consistent BICLA/SRI(4) results, with dual BICLA/SRI(4) responses favoring anifrolum.
A subgroup of BICLA non-responders /SRI(4) responders was identified in which an imbalance of key factors contributing to BICLA/SRI(4) discordance (disease activity, glucocorticoid tapering) disproportionately favors TULIP-1 placebo dose gro.
CONCLUSIONS CONCLUSIONS : Across all trials, the majority of patients had consistent BICLA/SRI(4) results, with dual BICLA/SRI(4) responses favoring anifrolum.
Bruce IN, Furie RA, Morand EF , et a.
Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 tria.
Annals of the Rheumatic Diseases2022;81 : 962-96 , et al Annals of the Rheumatic Diseases: Leave a message here
