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
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.
Efficacy and Safety of the Bruton's Tyrosine Kinase Inhibitor Evobrutinib in Systemic Lupus Erythematosus: Results of a Phase II, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Trial
ACR Open Rheumatol. 2023;5(1):38–48 doi: 10.1002/acr2.11511
Results of a phase II trial of evobrutinib suggest that Bruton's Tyrosine Kinase (BTK) inhibition is not an efficacious therapeutic intervention over standard of care therapy for patients with SLE.
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.
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.
Deucravacitinib, a Tyrosine Kinase 2 Inhibitor, in Systemic Lupus Erythematosus: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial
Arthritis Rheumatol. 2022. Epub ahead of print doi: 10.1002/art.42391
Phase II trial results of deucravacitinib support the potential benefits of TYK2 inhibition in SLE.
Lupus Low Disease Activity State and Remission and Risk of Mortality in Patients with Systemic Lupus Erythematosus: A Prospective, Multinational, Longitudinal Cohort Study
Lancet Rheumatol. 2022. Epub ahead of print. doi: 10.1016/S2665-9913(22)00304-6
Lupus low disease activity state (LLDAS) significantly reduced the risk of mortality in patients with SLE.
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.
Nat Med. 2022;28(10):2124–2132 doi: 10.1038/s41591-022-02017-5
Data suggest that CD19 chimeric antigen receptor (CAR) T cell transfer is feasible, tolerable and highly effective in patients with SLE.
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.
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.