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.
Clinical and biomarker responses to BI 655064, an antagonistic anti-CD40 antibody, in patients with active lupus nephritis: a randomized, double-blind, placebo-controlled, phase II trial
Arthritis Rheumatol. 2023 doi: 10.1002/art.42557. Epub ahead of print.
This phase II study of BI 655064 in patients with active LN did not meet the primary endpoint of CRR at Week 52, however, post-hoc analyses suggest a potential benefit of BI 655064 180 mg in patients with active LN.
Expert Opin Investig Drugs 2023;15:1-9 doi 10.1080/13543784.2023.2212154
Cho, et al. discuss the current challenges in the approval of CLE drugs and suggest outcome measures that could streamline the process. They also discuss the pharmacodynamics of litifilimab and the current status of clinical trials.
Rapid Efficacy of Anifrolumab Across Multiple Subtypes of Recalcitrant Cutaneous Lupus Erythematosus Parallels Changes in Discrete Subsets of Blood Transcriptomic and Cellular Biomarkers
Br J Dermatol. 2023 doi: 10.1093/bjd/ljad089
Prospective single-centre study of anifrolumab in refractory mucocutaneous SLE, indicates rapid efficacy of anifrolumab in discoid lupus erythematosus (DLE) and rituximab-resistant CLE.
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.
Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Trial
ACR Open Rheumatol. 2023;5(1):38–48 doi: 10.1002/acr2.11511
Results of a phase II trial of evobrutinib suggest that Bruton's Tyrosine Kinase (BTK) inhibition is not an efficacious therapeutic intervention over standard of care therapy for patients with SLE.
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.
A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus
Arthritis Rheumatol. 2022. Epub ahead of print doi: 10.1002/art.42392
Long-term extension study shows an acceptable long-term safety profile of anifrolumab in SLE, in addition to sustained improvements in disease activity and reduction in glucocorticoid use.