Clear Search

Showing 10 results for “Safety” published 2025.

October 2025

A Phase 3 trial of telitacicept for systemic lupus erythematosus

N Engl J Med 2025;393:1475-85 Doi: 10.1056/NEJMoa2414719

In this 52-week trial involving participants with active SLE who were receiving background therapy, the incidence of a clinical response was higher with telitacicept than with PBO. van Vollenhoven et al. report efficacy and safety results of a Phase 3 trial of telitacicept at a dose of 160mg weekly as compared with PBO in Chinese persons with active SLE.

more…

Secukinumab in active lupus nephritis: Results from Phase III, randomised, placebo controlled study (SELUNE) and open-label extension study

Rheumatology 2025 Doi: 10.1093/rheumatology/keaf536 Epub ahead of print

Secukinumab did not demonstrate superior efficacy over PBO in patients with active LN; secukinumab was well-tolerated with no new or unexpected safety signals detected. A Phase-III core study (SELUNE) and an extension study, were conducted by Zhao et al. to evaluate the efficacy and safety of SC secukinumab 300mg compared with PBO, in combination with the SoC, in patients with active LN.

more…

EULAR recommendations for the management of systemic lupus erythematosus with kidney involvement: 2025 update

Ann Rheum Dis 2025;0:1−16 Doi: 10.1016/j.ard.2025.09.007

The updated EULAR recommendations provide evidence- and expert-based consensus on the management of SLE with kidney involvement, adjusted for severity, and taking into consideration long-term efficacy, safety, cost, and local availability of drugs. Fanouriakis A et al. updated the 2019 EULAR/ ERA-EDTA recommendations for the management of SLE with kidney involvement, taking into consideration emerging evidence and recent developments in the field.

more…

September 2025

Efficacy and safety of upadacitinib as monotherapy or combined with elsubrutinib for the treatment of systemic lupus erythematosus: results through 104 weeks in a long-term extension study

RMD Open 2025;11:e005742 Doi:10.1136/rmdopen-2025-005742

In this long-term extension of the Phase 2 SLEek study, Merrill et al. report that through an additional 56-weeks of treatment, upadacitinib as monotherapy or combined with elsubrutinib demonstrated sustained or improved efficacy in multiple endpoints in patients with moderately to severely active SLE.

more…

August 2025

CAR T cell therapy efficacy and safety in SLE: A systematic review and pooled analysis of 47 patients across 10 studies

Doi: 10.1007/s00210-025-04425-z

Sayed OA et al. reported that CAR T cell therapy showed promise in refractory SLE, achieving durable remission with manageable toxicity; however further trials are needed to confirm long-term outcomes. Authors consolidated the current evidence on CAR T cell therapy in the treatment of SLE.

more…

Efficacy, pharmacokinetics and safety of iscalimab (CFZ533) in patients with proliferative lupus nephritis: A randomised, double-blind, placebo-controlled, Phase II study

RMD Open 2025;11:e005557 Doi:10.1136/rmdopen-2025-005557

Shen N et al. report that iscalimab was clinically effective and generally well tolerated; in addition, it was devoid of the thromboembolic risk, characteristic of Fc active anti-CD40L therapies.

more…

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.

more…

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.

more…

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.

more…

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.

more…