Baricitinib for Systemic Lupus Erythematosus: a Double-blind, Randomised, Placebo-controlled, Phase 3 trial (SLE-BRAVE-II)
Lancet. 2023 doi: 10.1016/S0140-6736(22)02546-6
Negative results of SLE-BRAVE-II trial show that evidence for the efficacy of baricitinib in SLE is inconclusive.
Assessing the Costs of Neuropsychiatric Disease in the Systemic Lupus International Collaborating Clinics (SLICC) Cohort using Multistate Modelling
Arthritis Care Res (Hoboken). 2023 doi: 10.1002/acr.25090.
First study to assess the long-term economic burden of neurologic and/or psychiatric (NP) lupus in an international, multi-ethnic inception cohort, concludes that patients with new/ongoing SLE or non-SLE NP events incurred higher direct and indirect costs.
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.
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.
Concordance and discordance in SLE clinical trial outcome measures: analysis of three anifrolumab phase 2/3 trials
Ann Rheum Dis 2022;81:962–969 doi: 10.1136/annrheumdis-2021-221847
Bruce, et al. investigate the degree of concordance between BICLA and SRI-4 response across anifrolumab trials (TULIP-1, TULIP-2 and MUSE) in order to better understand drivers of discrepant systemic lupus erythematosus (SLE) trial results.
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.
Clinical meaningfulness of a British Isles Lupus Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab
Lancet Rheumatol 2022;4:e198–207
In patients with moderate-to-severe SLE, British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responders report improvements in disease activity, health-related quality of life, fatigue, and pain.
This international Phase 2 study aimed to assess the efficacy and safety of baricitinib, an oral JAK-1 and -2 inhibitor, in patients with SLE who were not adequately controlled despite standard background therapy.