Literature Highlights - January 2023

systematic review, targeted treatments, biologics, clinical trial, belimumab, anifrolumab, Bruton’s Tyrosine Kinase, BTK, inhibitor, evobrutinib, SLE, systemic lupus erythematosus, dose-ranging, pregnancy, obstetric comorbidities, , childhood-onset SLE (cSLE), treatment, safety, CD40 ligand, dapirolizumab pegol, exposure-response, population pharmacokinetics

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January 2023

New Biologics and Targeted Therapies in Systemic Lupus: From New Molecular Targets to New Indications. A Systematic Review

Joint Bone Spine. 2023. Epub ahead of print doi: 10.1016/j.jbspin.2023.105523

Systematic review of new biologics and targeted therapies in systemic lupus identifies a highly diversified pipeline of investigational drugs that will hopefully enable a more optimal treat-to-target strategy.

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December 2022

Low-dose Interleukin-2 Therapy in Active Systemic Lupus Erythematosus (LUPIL-2): A Multicentre, Double-blind, Randomised and Placebo-controlled Phase II Trial

Ann Rheum Dis. 2022;81:1685–1694

Phase II proof-of-concept trial confirms that low-dose IL-2 therapy can safely and selectively expand the Treg population, and is capable of reducing disease activity in patients with SLE.

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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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Belimumab Use During Pregnancy: Interim Results of the Belimumab Pregnancy Registry

Birth Defects Res. 2022. Epub ahead of print doi: 10.1002/bdr2.2091

There was no pattern or common mechanism of birth defects associated with belimumab within the Belimumab Pregnancy Registry (BPR) data.

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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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