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Showing 8 results for “Phase III”.

March 2025

LLDAS and remission attainment with anifrolumab treatment in patients with systemic lupus erythematosus: results from the TULIP and long-term extension randomised controlled trials

Ann Rheum Dis. 2025:S0003-496700071-8. DOI: 10.1016/j.ard.2025.01.016. Epub ahead of print

Morand et al. conducted a post-hoc analysis of the phase III TULIP-1 and TULIP-2 trials and their long-term extension, including 369 patients with moderate to severe SLE, to evaluate the long-term impact of anifrolumab on attainment of LLDAS and DORIS-defined remission. The results demonstrated that anifrolumab significantly improved the likelihood, speed, and duration of LLDAS and DORIS remission versus placebo over 4 years, with benefits sustained throughout the treatment period.

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Belimumab efficacy in mucocutaneous lupus erythematosus: a large post-hoc analysis from five phase III clinical trials

Rheumatol, 2025. Epub ahead of print. DOI: 10.1093/rheumatology/keaf145

Grosso et al. conducted a post-hoc analysis of five phase III trials, including 3086 patients, to evaluate the efficacy of belimumab in improving mucocutaneous manifestations of SLE. The results demonstrated that belimumab significantly improved disease activity as measured by the mcBILAG and mcSLEDAI-2K indices compared with placebo and reduced flare rates in patients with high disease activity and serological positivity.

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February 2024

Predictors of Renal Flares in Systemic Lupus Erythematosus: A Post-hoc Analysis of Four Phase III Clinical Trials of Belimumab

Rheumatology (Oxford) 2024 DOI: 10.1093/rheumatology/keae023 Epub ahead of print

High baseline proteinuria levels, hypoalbuminaemia, and C3 consumption were associated with
renal flare development. Renal flares remain common in patients with SLE, however causative factors are still largely unknown. Jagerback, et al. conducted a post-hoc analysis of pooled BLISS trial data to identify predictors of renal flares.

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July 2023

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.

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June 2023

Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials

Rheumatology (Oxford) 2023;63(2):338–48 doi: 10.1093/rheumatology/kead253

The protection conferred from belimumab against renal flare development in patients treated for extra-renal SLE appears enhanced when administered along with antimalarials (AMA).

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April 2023

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.

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December 2022

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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May 2022

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.

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