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Showing 39 results for “Safety”.

November 2022

Safety and Efficacy of Belimumab in Patients with Lupus Nephritis

Clin J Am Soc Nephrol. 2022;17:1620–1630 doi: 10.2215/CJN.02520322

This 28-week, open-label extension of BLISS-LN found no new safety signals and maintained efficacy with belimumab, in patients with lupus nephritis.

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Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus

N Engl J Med. 2022;387(10):894–904 doi: 10.1056/NEJMoa2118025

Phase 2 study, in patients with systemic lupus erythematosus, shows that litifilimab is associated with a greater reduction from baseline in the number of swollen and tender joints than placebo, over a period of 24 weeks.

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September 2022

Trial of Anti-BDCA2 Antibody Litifilimab for Cutaneous Lupus Erythematosus

N Engl J Med. 2022;387(4):321–331 doi: 10.1056/NEJMoa2118024

Phase II study, in patients with active cutaneous lupus erythematosus, shows that litifilimab improved scores on a measure of skin disease activity, over 16 weeks, compared to placebo.

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Effect and safety profile of belimumab and tacrolimus combination therapy in thirty‑three patients with systemic lupus erythematosus

Clin Rheumatol. 2022. Epub ahead of print doi: 10.1007/s10067-022-06325-6

A single-centre analysis of patients with SLE administered tacrolimus and belimumab shows this combination therapy to be well-tolerated, with a good efficacy profile and glucocorticoid-reducing effect.

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July 2022

Phase 3, multicentre, randomised, placebo-controlled study evaluating the efficacy and safety of ustekinumab in patients with systemic lupus erythematosus

van Vollenhoven RF, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/ard-2022-222858.

Phase 3 study evaluating the efficacy and safety of ustekinumab in patients with active SLE, despite receiving standard-of-care, does not achieve primary and key secondary endpoints.

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June 2022

Filgotinib or lanraplenib in moderate to severe cutaneous lupus erythematosus: a phase 2, randomized, double-blind, placebo-controlled study

Rheumatology (Oxford). 2022;61(6):2413–2423 doi: 10.1093/rheumatology/keab685

Proof-of-concept study for the safety and efficacy of filgotinib (FIL) and lanraplenib (LANRA) in cutaneous lupus (CLE) fails to meet primary endpoint, but select subgroups displayed a numerically greater treatment response to FIL relative to placebo.

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May 2022

Anifrolumab efficacy and safety by type I interferon gene signature and clinical subgroups in patients with SLE: post hoc analysis of pooled data from two phase III trials

Ann Rheum Dis. 2022; 0:1–11. doi: 10.1136/annrheumdis-2021-221425

IFN-I signalling plays a key role in SLE pathogenesis, and anifrolumab has demonstrated inhibitory effects on IFN-I signalling in patients with SLE. Vital, et al. characterised efficacy and safety of anifrolumab in patients with moderate-to-severe SLE based on interferon gene signature, demographic and clinical subgroups using data pooled from the Phase III TULIP-1 and -2 trials.

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Efficacy and Safety of Obinutuzumab in Systemic Lupus Erythematosus Patients with Secondary Non-response to Rituximab

Rheumatology 2022;00:1–5 DOI.org/10.1093/rheumatology/keac150

Arnold, et al. present the first case series reporting the efficacy and safety of obinutuzumab in patients with treatment refractory SLE. The results indicate that, for this group of patients with limited treatment approaches, obinutuzumab could be a potential option.

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March 2022

Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis

Ann Rheum Dis. 2022;81(4):496–506 doi: 10.1136/annrheumdis-2021-221478

Despite not meeting the primary endpoint, this Phase II trial of anifrolumab in patients with active lupus nephritis (LN) demonstrates that anifrolumab IR is associated with numerical improvements over placebo across endpoints – including complete renal response – in patients with active LN.

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