Lupus Low Disease Activity State Attainment in the Phase 3 TULIP Trials of Anifrolumab in Active Systemic Lupus Erythematosus
Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-222748 Epub ahead of print
Post-hoc anaylsis of TULIP trials shows that, compared with placebo, anifrolumab treatment was associated with earlier, more frequent, and more prolonged and sustained lupus low disease activity state (LLDAS).
Low-dose Interleukin-2 Therapy in Active Systemic Lupus Erythematosus (LUPIL-2): A Multicentre, Double-blind, Randomised and Placebo-controlled Phase II Trial
Ann Rheum Dis. 2022;81:1685–1694
Phase II proof-of-concept trial confirms that low-dose IL-2 therapy can safely and selectively expand the Treg population, and is capable of reducing disease activity in patients with SLE.
Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus
van Vollenhoven RF, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/ard-2022-222858.
Phase 3 study evaluating the efficacy and safety of ustekinumab in patients with active SLE, despite receiving standard-of-care, does not achieve primary and key secondary endpoints.
Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials
Ann Rheum Dis 2022;81:962–969 doi: 10.1136/annrheumdis-2021-221847
Bruce, et al. investigate the degree of concordance between BICLA and SRI-4 response across anifrolumab trials (TULIP-1, TULIP-2 and MUSE) in order to better understand drivers of discrepant systemic lupus erythematosus (SLE) trial results.
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
Ann Rheum Dis. 2022; 0:1–11. doi: 10.1136/annrheumdis-2021-221425
IFN-I signalling plays a key role in SLE pathogenesis, and anifrolumab has demonstrated inhibitory effects on IFN-I signalling in patients with SLE. Vital, et al. characterised efficacy and safety of anifrolumab in patients with moderate-to-severe SLE based on interferon gene signature, demographic and clinical subgroups using data pooled from the Phase III TULIP-1 and -2 trials.
Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis
Ann Rheum Dis. 2022;81(4):496–506 doi: 10.1136/annrheumdis-2021-221478
Despite not meeting the primary endpoint, this Phase II trial of anifrolumab in patients with active lupus nephritis (LN) demonstrates that anifrolumab IR is associated with numerical improvements over placebo across endpoints – including complete renal response – in patients with active LN.