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Showing 34 results for “Safety”.

June 2024

Efficacy and safety of telitacicept therapy in systemic lupus erythematosus with hematological involvement

Clin Rheumatol. 2024 May 20 doi: 10.1007/s10067-024-06992-7. Epub ahead of print

This real-world combination of telitacicept and standard treatment demonstrated significant improvements in anaemia, as well as increased leukocyte and platelet levels in patients with SLE and haematological involvement. Here, investigators sought to evaluate the efficacy and safety of telitacicept in combination with standard treatment in SLE patients specifically with haematological involvement.

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April 2024

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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March 2024

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.

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February 2024

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.

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January 2024

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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December 2023

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.

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August 2023
July 2023

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.

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June 2023

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.

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