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Showing 6 results for “Tolerability”.

December 2024

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Lancet Rheumatol. 2024. Epub ahead of print. DOI: 10.1016/S2665-9913(24)00246-7

Askanase et al. assessed the efficacy, safety, and tolerability of cenerimod in patients with moderate-to-severe SLE. While the primary endpoint of reducing mSLEDAI-2K scores at Month 6 was not achieved, cenerimod 4.0mg showed a significant reduction in disease activity versus placebo. Adverse events, including lymphopenia, were dose-dependent but manageable, and overall treatment was well tolerated.

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October 2024

Safety, pharmacokinetics, biomarker response and efficacy of E6742: a dual antagonist of Toll-like receptors 7 and 8, in a first-in-patient, randomised, double-blind, phase I/II study in systemic lupus erythematosus

RMD Open 2024;10:e004701 DOI 10.1136/rmdopen-2024-004701

Tanaka et al. conducted a phase I/II study to evaluate the safety, pharmacokinetics, biomarker response, and efficacy of E6742, a dual antagonist of Toll-like receptors 7 and 8, in patients with systemic lupus erythematosus (SLE). The treatment demonstrated a favourable safety profile, with no serious adverse events, while effectively suppressing interferon gene signatures and showing promising preliminary efficacy.

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August 2023
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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January 2022
October 2021