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Showing 15 results for “Phase II”.

April 2025

Unsupervised machine learning identifies distinct systemic lupus erythematosus patient endotypes with differential response to belimumab

Rheumatol (Oxford), 2025 DOI: 10.1093/rheumatology/keaf215. Epub ahead of print

Depascale et al. used unsupervised machine learning to identify three SLE endotypes based on B cell immunophenotyping and serological profiles. Belimumab was most effective in patients with transitional and naïve B cell enrichment (Cluster 2), where it significantly increased the likelihood of achieving sustained LLDAS and DORIS remission.

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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

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;75(11):1983–93 doi: 10.1002/art.42557.

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.

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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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January 2023
December 2022

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.

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