Publications
Find coverage of the latest original articles on Lupus, focusing on those with data on therapeutic interventions and those that have clinical impact.
This activity is supported by an educational grant from AstraZeneca.
Evaluation of RNase Therapy in Systemic Lupus Erythematosus: A Randomised Phase 2a Clinical Trial of RSLV-132
Lupus Sci Med. 2024;11:e001113 DOI 10.1136/lupus-2023-001113
Treatment with RSLV-132 was associated with lower rates of SAEs than placebo, although RSLV-132 therapy was not associated with a significant improvement in the mean CLASI score relative to placebo. However, results suggest that further evaluations of RSLV-132 in SLE should be undertaken with patients with more active disease who are most likely to benefit from RNase therapy.
Telitacicept in Patients with Active Systemic Lupus Erythematosus: Results of A Phase 2b, Randomised, Double-blind, Placebo-controlled Trial
Ann Rheum Dis. 2023; DOI: 10.1136/ard-2023-224854
This Phase 2 trial demonstrated the efficacy and acceptable safety profile of telitacicept in patients with SLE. The safety profile of telitacicept was comparable with that observed in clinical trials of other B cell-targeting agents.
Keywords:
Efficacy and Safety of Telitacicept in Patients with Systemic Lupus Erythematosus: A Multicentre, Retrospective, Real-World Study
Lupus Sci. Med. 2023;10(2):e001074 DOI 10.1136/lupus-2023-001074
In this study, telitacicept add-on therapy demonstrated desirable real-world safety and efficacy profiles for the management of SLE, LN, and patients with haematological abnormalities.
Safety and Efficacy of Long-term Voclosporin Treatment for Lupus Nephritis in the Phase 3 AURORA 2 Clinical Trial
Arthritis Rheumatol. 2023;76(1):59–67 DOI: 10.1002/art.42657
AURORA 2 demonstrated the safety and tolerability of continued administration of voclosporin over 3 years of treatment in patients with LN.
Keywords:
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;75(11):1983–93 doi: 10.1002/art.42557.
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.
Litifilimab (BIIB059), a Promising Investigational Drug for Cutaneous Lupus Erythematosus
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.
Keywords:
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.