Publications
Find coverage of the latest original articles on Lupus, focusing on those with data on therapeutic interventions and those that have clinical impact.
CD19 CAR T-Cell therapy in autoimmune disease - A case series with follow-up
N Engl J Med 2024;390(8):687–700 DOI 10.1056/NEJMoa2308917
In this case series by Müller, et al., eight patients who received a CD19 CAR T-cell infusion achieved Definition of Remission in SLE (DORIS) remission, Lupus Low Disease Activity State and a SLEDAI 2K score of 0 at 6 months post-infusion. Long-term follow-up through 24 months showed that SLE disease activity remained absent
in all eight patients.
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Mycophenolate mofetil withdrawal in patients with systemic lupus erythematosus: A multicentre, open-label, randomised controlled trial
Lancet Rheumatol 224;6(3):e168–77 DOI 10.1016/S2665-9913(23)00320-X
Mycophenolate mofetil (MMF) withdrawal was not significantly inferior to MMF maintenance through Week 60 in patients with SLE that had been treated with MMF for ≥1 year.
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TYK2: An emerging therapeutic target in rheumatic disease
Nat Rev Rheumatol 2024;20(4):232–40 DOI 10.1038/s41584-024-01093-w
TYK2 inhibitors hold promise for the treatment of a distinct spectrum of autoimmune diseases, including SLE, and could potentially have a safety profile that differs from other JAK inhibitors.
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.
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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.
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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.
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.