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Showing 8 results for “phase II” published 2022.

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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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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July 2022

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.

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June 2022

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).

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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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March 2022

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.

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