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Showing 32 results for “Safety”.

July 2025

BCMA-targeted CAR T cell therapy can effectively induce disease remission in refractory lupus nephritis

Ann Rheum Dis 2025;0:1−9

Hu et al. report that anti-BCMA only CAR T cell can help LN patients safely and effectively, indicating its potential to be a feasible therapeutic strategy in treating autoimmune diseases with abnormal humoral immune responses.

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Effect of long-term voclosporin treatment on renal histology in patients with active lupus nephritis with repeat renal biopsies

Arthritis & Rheumatology 2025; 0:1–7 doi: 10.1002/art.43209

Exposure to voclosporin for a median of 18 months was not associated with onset or progression of nephrotoxicity based on evaluation of histologic compartments and vascular lesions. Rovin et al. characterised the impact of voclosporin on kidney histology in patients with LN who had protocolized repeat kidney biopsies in the AURORA clinical trials.

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February 2025

Efficacy and safety of obinutuzumab in active lupus nephritis

NEJM, 2025. Epub ahead of print. DOI: 10.1056/NEJMoa2410965

Furie et al. demonstrated that obinutuzumab plus standard therapy significantly improved complete renal response at Wk76 compared with placebo. No unexpected safety signals were identified, though infections and COVID-19-related events were more frequent in the obinutuzumab group.

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Belimumab versus telitacicept in sequential treatment after rituximab for refractory lupus nephritis: A real-world multicentre study

Lupus Science & Medicine, 2025;12:e001296 DOI:10.1136/lupus-2024-001296

Chen et al. demonstrated that sequential treatment with belimumab or telitacicept following rituximab (RTX) is a potential therapeutic approach for treating refractory LN. Major AEs included immunoglobin deficiency, respiratory tract infections and urinary tract infections, which are consistent with previous studies.

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December 2024

Comparison of a voclosporin-based triple immunosuppressive therapy to high-dose glucocorticoid-based immunosuppressive therapy: A propensity analysis of the AURA-LV and AURORA 1 studies and ALMS

Lupus Science & Medicine 2024;11:e001319 DOI: 10.1136/lupus-2024-001319

Dall’Era et al. conducted a propensity analysis to compare voclosporin-based triple immunosuppressive therapy with high-dose GC-based regimens for active LN. Voclosporin showed fewer AEs, improved safety, and significantly reduced proteinuria over six months, suggesting a superior risk-benefit profile for patients with lupus nephritis.

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Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Lancet Rheumatol. 2024. Epub ahead of print. DOI: 10.1016/S2665-9913(24)00246-7

Askanase et al. assessed the efficacy, safety, and tolerability of cenerimod in patients with moderate-to-severe SLE. While the primary endpoint of reducing mSLEDAI-2K scores at Month 6 was not achieved, cenerimod 4.0mg showed a significant reduction in disease activity versus placebo. Adverse events, including lymphopenia, were dose-dependent but manageable, and overall treatment was well tolerated.

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November 2024

Efficacy and safety of sodium-glucose co-transporter 2 inhibitors for the primary prevention of cardiovascular, renal events and safety outcomes in patients with systemic lupus erythematosus and comorbid type 2 diabetes: A population-based target trial emulation

Arthritis Rheumatol 2024. Epub ahead of print DOI: 10.1002/art.43037

Ma et al. assessed the efficacy and safety of sodium-glucose co-transporter 2 inhibitors (SGLT2i) compared with dipeptidyl peptidase 4 inhibitors (DPP4i) in preventing cardiovascular and renal events in patients with both SLE and type 2 diabetes (T2D). SGLT2i use significantly reduced risks for acute kidney injury, chronic kidney disease, end-stage renal disease, and heart failure, though it increased genital infection risk.

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Effect of iberdomide on cutaneous manifestations in systemic lupus erythematosus: a randomized phase 2 clinical trial

JAAD. 2024. Epub ahead of print DOI: 10.1016/j.jaad.2024.09.074

Werth et al. demonstrated that iberdomide significantly improved cutaneous lupus erythematosus (CLE) outcomes, particularly in subacute and chronic CLE patients, by reducing Cutaneous Lupus Area and Severity Index Activity (CLASI-A) scores. The study showed continued efficacy through 24 weeks, with the 0.45 mg dose providing the greatest improvement in patients with severe baseline scores, and iberdomide was well-tolerated over 104 weeks.

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October 2024

Safety, pharmacokinetics, biomarker response and efficacy of E6742: a dual antagonist of Toll-like receptors 7 and 8, in a first-in-patient, randomised, double-blind, phase I/II study in systemic lupus erythematosus

RMD Open 2024;10:e004701 DOI 10.1136/rmdopen-2024-004701

Tanaka et al. conducted a phase I/II study to evaluate the safety, pharmacokinetics, biomarker response, and efficacy of E6742, a dual antagonist of Toll-like receptors 7 and 8, in patients with systemic lupus erythematosus (SLE). The treatment demonstrated a favourable safety profile, with no serious adverse events, while effectively suppressing interferon gene signatures and showing promising preliminary efficacy.

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September 2024

Efficacy and safety of sequential therapy with subcutaneous belimumab and one cycle of rituximab in patients with systemic lupus erythematosus: the phase 3, randomised, placebo-controlled BLISS-BELIEVE study

Ann Rheum Dis 2024;0:1–11 DOI 10.1136/ard-2024-225686.

Aranow et al. evaluated the efficacy and safety of combining subcutaneous belimumab with one cycle of rituximab in SLE. Sequential therapy did not show a statistically significant improvement in disease control over belimumab monotherapy, but did achieve nominally better reductions in disease activity markers.

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