Sustained Glucocorticoid Tapering in the Phase 3 Trials of Anifrolumab: A post hoc Analysis of the TULIP-1 and TULIP-2 Trials
Rheumatology (Oxford). 2023 doi: 10.1093/rheumatology/keac491
Pooled analysis of the TULIP trials demonstrates that sustained glucocorticoid (GC) tapering is associated with several clinical benefits in patients with moderate-to-severe SLE.
Lupus Low Disease Activity State Attainment in the Phase 3 TULIP Trials of Anifrolumab in Active Systemic Lupus Erythematosus
Ann Rheum Dis. 2023. doi: 10.1136/ard-2022-222748
Post-hoc anaylsis of TULIP trials shows that, compared with placebo, anifrolumab treatment was associated with earlier, more frequent, and more prolonged and sustained lupus low disease activity state (LLDAS).
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.
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.
Indirect treatment comparison of anifrolumab efficacy versus belimumab in adults with systemic lupus erythematosus
J Comp Eff Res. 2022;11(10):765–777 doi: 10.2217/cer-2022-0040
Population-adjusted comparative study provides insights for decision makers and clinicians about the comparative efficacy of anifrolumab and belimumab in patients with moderate-to-severe systemic lupus erythematosus (SLE) who are receiving standard therapy.
In the absence of head-to-head comparisons, Bruce, et al. assessed the comparative efficacy of the two biological therapies currently approved in the EU and USA for the treatment of moderate-to-severe SLE (anifrolumab 300 mg and belimumab 10 mg/kg).
After adjusting for important cross-trial differences, their results showed that anifrolumab was associated with significantly greater treatment benefits than belimumab.
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.
Phase II randomised trial of type I interferon inhibitor anifrolumab in patients with active lupus nephritis
Ann Rheum Dis. 2022;81(4):496–506 doi: 10.1136/annrheumdis-2021-221478
Despite not meeting the primary endpoint, this Phase II trial of anifrolumab in patients with active lupus nephritis (LN) demonstrates that anifrolumab IR is associated with numerical improvements over placebo across endpoints – including complete renal response – in patients with active LN.
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.
Efficacy of anifrolumab across organ domains in patients with moderate-to-severe systemic lupus erythematosus: a post-hoc analysis of pooled data from the TULIP-1 and TULIP-2 trials
Lancet Rheumatol. Published online February 3, 2022
Across two pivotal phase 3 trials (TULIP-1 and TULIP-2), anifrolumab treatment improved systemic lupus erythematosus (SLE) disease activity across multiple organ domains, compared with placebo.
N Engl J Med 2020:211–20
Morand et al demonstrate a greater BICLA response at Week 52 for patients treated with anifrolumab versus those treated with placebo.