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Showing 14 results for “safety” published 2022.

January 2023
December 2022

A Randomized, Placebo-Controlled Phase III Extension Trial of the Long-Term Safety and Tolerability of Anifrolumab in Active Systemic Lupus Erythematosus

Arthritis Rheumatol. 2022. Epub ahead of print doi: 10.1002/art.42392

Long-term extension study shows an acceptable long-term safety profile of anifrolumab in SLE, in addition to sustained improvements in disease activity and reduction in glucocorticoid use.

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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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