Ann Rheum Dis 2023; 2023-224762 DOI: 10.1136/ard-2023-224762 Epub ahead of print
The objective of this international task force was to update the EULAR recommendations for the management of SLE. The Task Force agreed on 5 overarching principles and 13 recommendations, generating an overall framework for the approach to a patient with SLE. The updated recommendations provide consensus guidance on the management of SLE, combining evidence and expert opinion.
Sustained Glucocorticoid Tapering in the Phase 3 Trials of Anifrolumab: A post hoc Analysis of the TULIP-1 and TULIP-2 Trials
Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/keac491
Pooled analysis of the TULIP trials demonstrates that sustained glucocorticoid (GC) tapering is associated with several clinical benefits in patients with moderate-to-severe SLE.
Baricitinib for Systemic Lupus Erythematosus: a Double-blind, Randomised, Placebo-controlled, Phase 3 Trial (SLE-BRAVE-I)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02607-1
Primary endpoint in SLE-BRAVE-I study was met for the 4 mg baricitinib group, however, key secondary endpoints were not.
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
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).
N Engl J Med. 2022;387(10):894–904 doi: 10.1056/NEJMoa2118025
Phase 2 study, in patients with systemic lupus erythematosus, shows that litifilimab is associated with a greater reduction from baseline in the number of swollen and tender joints than placebo, over a period of 24 weeks.
N Engl J Med. 2022;387(4):321–331 doi: 10.1056/NEJMoa2118024
Phase II study, in patients with active cutaneous lupus erythematosus, shows that litifilimab improved scores on a measure of skin disease activity, over 16 weeks, compared to placebo.
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.
Clinical meaningfulness of a British Isles Lupus Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab
Lancet Rheumatol 2022;4:e198–207
In patients with moderate-to-severe SLE, British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders report improvements in disease activity, health-related quality of life, fatigue, and pain.