A randomized, placebo‐controlled phase III extension trial of the long‐term safety and tolerability of anifrolumab in active systemic lupus erythematosus

KC Kalunian, R Furie, EF Morand… - Arthritis & …, 2023 - Wiley Online Library
… This study characterizes safety and tolerability of intravenous anifrolumab versus placebo in
… and tolerability (5, 12-14) of the recommended 300 mg dose for anifrolumab administered …

The long-term safety and tolerability of anifrolumab for patients with systemic lupus erythematosus in Japan: TULIP-LTE subgroup analysis

Y Tanaka, T Atsumi, M Okada, T Miyamura… - Modern …, 2024 - academic.oup.com
… any anifrolumab exposure (all anifrolumab) … anifrolumab 300 mg in LTE were included in
the ‘all placebo’ group before the first dose of anifrolumab in the LTE and in the ‘all anifrolumab

… tolerability of anifrolumab, a monoclonal antibody targeting type I interferon receptor, in Japanese patients with systemic lupus erythematosus: a multicenter, phase 2 …

Y Tanaka, T Takeuchi, M Okada, T Ishii… - Modern …, 2020 - academic.oup.com
… the safety and tolerability of anifrolumab, a … lupus erythematosus (SLE). Methods: In this
open-label, phase 2, dose-escalation study, patients received intravenous (IV) anifrolumab 100, …

Long‐term safety and efficacy of anifrolumab in adults with systemic lupus erythematosus: results of a phase II open‐label extension study

WW Chatham, R Furie, A Saxena… - Arthritis & …, 2021 - Wiley Online Library
… IIb RCT, which included open-label anifrolumab treatment for up to 3 years. The … and
tolerability of anifrolumab. A secondary objective was to evaluate the immunogenicity of anifrolumab

Safety, tolerability and pharmacokinetics of subcutaneous and intravenous anifrolumab in healthy volunteers

R Tummala, T Rouse, A Berglind… - Lupus Science & …, 2018 - lupus.bmj.com
… of anifrolumab 300 mg and anifrolumab 600 mg exhibited dose-proportional pharmacokinetics
in healthy volunteers. Anifrolumab … to severe systemic lupus erythematosus. Arthritis …

Pharmacokinetics, pharmacodynamics, and safety of subcutaneous anifrolumab in patients with systemic lupus erythematosus, active skin disease, and high type I …

IN Bruce, A Nami, E Schwetje, ME Pierson… - The Lancet …, 2021 - thelancet.com
… The safety and tolerability of subcutaneous anifrolumab was similar to that of intravenous …
signature with sifalimumab or anifrolumab in systemic lupus erythematosus (SLE) patients in …

Anifrolumab in systemic lupus erythematosus: current knowledge and future considerations

E Anderson, R Furie - Immunotherapy, 2020 - Taylor & Francis
… An open-label extension of the MUSE trial (NCT01753193 [Citation37]) evaluated the
long-term safety and tolerability of anifrolumab 300 mg iv. over 156 weeks. Of the 218 subjects …

Evaluation of anifrolumab safety in systemic lupus erythematosus: a meta-analysis and systematic review

Z Liu, R Cheng, Y Liu - Frontiers in Immunology, 2022 - frontiersin.org
… The latest pharmacokinetic study of anifrolumab and systemic lupus erythematosus also
supports this conclusion (24). Ian N Bruce et al. (NCT02962960) found that subcutaneous …

Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials

R Tummala, G Abreu, L Pineda, MA Michaels… - Lupus science & …, 2021 - lupus.bmj.com
… The aim of this analysis was to evaluate the safety and tolerability of anifrolumab 300 mg …
with systemic lupus erythematosus: results from the systemic lupus international collaborating …

The efficacy and safety of anifrolumab in Japanese patients with systemic lupus erythematosus: TULIP-2 subanalysis

Y Tanaka, T Atsumi, M Okada, T Miyamura… - Modern …, 2023 - academic.oup.com
… Consistent with the overall population, anifrolumab had an acceptable safety and tolerability
… These results are concordant with the safety and tolerability of anifrolumab in Japanese …