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.
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 doi: 10.1002/art.42557. Epub ahead of print.
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.
Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials
doi: 10.1093/rheumatology/kead253 Epub ahead of print
The protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when administered along with antimalarials (AMA).
Evaluation of the LFA-REAL Clinician-reported Outcome (ClinRO) and Patient-reported Outcome (PRO): Prespecified Analysis of the Phase III Ustekinumab Trial in Patients with SLE
Lupus Sci Med. 2023 doi:10.1136/lupus-2022-000875
The Lupus Foundation of America Rapid Evaluation of Activity in Lupus (LFA-REAL) clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) systems show potential as a flexible resource in the evaluation of lupus disease activity and a simple, user-friendly outcome measure for SLE studies.
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.
Mechanism of action of baricitinib and identification of biomarkers and key immune pathways in patients with active systemic lupus erythematosus
Dörner T, et al. Ann Rheum Dis. 2022. Epub ahead of print. doi:10.1136/annrheumdis-2022-222335.
Phase II study results suggest that baricitinib 4 mg downregulates key cytokines that are upregulated in patients with SLE.
Baricitinib decreases anti‑dsDNA in patients with systemic lupus erythematosus: results from a phase II double‑blind, randomized, placebo‑controlled trial
Arthritis Res Ther 2022;24(1):112 doi: 10.1186/s13075-022-02794-x
Evaluation of serological activity, including antibodies against double-stranded DNA (anti-dsDNA), suggests that baricitinib may influence B cell activity in systemic lupus erythematosus (SLE).