Effect of Belimumab on Kidney-related Outcomes in Patients with Lupus Nephritis: Post Hoc Subgroup Analyses of the Phase 3 BLISS-LN Trial
Nephrol Dial Transplant. 2023 doi: 10.1093/ndt/gfad167 Epub ahead of print.
These data highlight the consistent benefit of belimumab versus placebo, combined with standard therapy, on kidney outcomes in both newly diagnosed and relapsed patients, and regardless of the use of GC pulses at induction.
Safety and Efficacy of Long-term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial
Arthritis Rheumatol. 2023 DOI: 10.1002/art.42657 Epub ahead of print
AURORA 2 demonstrated the safety and tolerability of continued administration of voclosporin over 3 years of treatment in patients with LN.
Update on the Efficacy and Safety Profile of Voclosporin: An Integrated Analysis of Clinical Trials in Lupus Nephritis
Arthritis Care Res (Hoboken). 2023 Jul;75(7):1399–1408 DOI: 10.1002/acr.25007
Pooled analysis of data from the AURA-LV phase 2 and AURORA 1 phase 3 trials of voclosporin in patients with active LN demonstrated that significantly more patients achieved a complete renal response at 1 year in the voclosporin than the control group (p<0.0001), with no observation of new safety signals.
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-II)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02546-6
Negative results of SLE-BRAVE-II trial show that evidence for the efficacy of baricitinib in SLE is inconclusive.
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).
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.
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.
Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials
Lancet Rheumatol. Published online February 3, 2022
Across two pivotal phase 3 trials (TULIP-1 and TULIP-2), anifrolumab treatment improved systemic lupus erythematosus (SLE) disease activity across multiple organ domains, compared with placebo.