Satralizumab

Review

Satralizumab

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In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2024 May 14.

PMID: 38985925
Bookshelf ID: NBK604846

Free Books & Documents

Review

Satralizumab

No authors listed.

Free Books & Documents

In: LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012.

2024 May 14.

PMID: 38985925
Bookshelf ID: NBK604846

Excerpt

Satralizumab is a cytolytic monoclonal antibody to the interleukin 6 receptor that is used to treat adolescents and adults with neuromyelitis optica spectrum disorder accompanied by an autoantibody to aquaporin-4. Satralizumab therapy has been associated with serum aminotransferase elevations during therapy but has not been linked to instances of clinically apparent liver injury.

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1. FDA. Clinical Review. 2020.
1. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000M... [ (FDA Summary of the data the safety and efficacy of satralizumab, submitted in support of the application for approval as therapy of neuromyelitis optica spectrum disorder, mentions ALT elevations in 19.5% to 36.5% [none above 5 times ULN] of satralizumab-treated versus 12.5% to 14.5% on placebo and bilirubin elevations in 8% to 12% vs none with placebo, but there were no ALT elevations accompanied by jaundice). ]
1. Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381:2114-2124.(Among 83 patients with NMOSD treated with satralizumab or placebo for an average of 2 years, relapses occurred I 20% vs 43% while adverse event rates were similar [95% vs 90%] including severe adverse events [17% vs 21%]; no mention of ALT elevations or hepatotoxicity). - PubMed
1. Traboulsee A, Greenberg BM, Bennett JL, Szczechowski L, Fox E, Shkrobot S, Yamamura T, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19:402-412.(Among 95 patients with NMOSD treated with satralizumab or placebo, relapse rates were 30% vs 50% while adverse event rates were higher with monoclonal therapy [92% vs 75%] and serious adverse events [27% vs 6%] but there were no differences in rates of serious infections or injection reactions, and no anaphylactic reactions; no mention of ALT elevations or hepatotoxicity). - PMC - PubMed
1. Heo YA. Satralizumab: first approval. Drugs. 2020;80:1477-1482.(Review of the mechanism of action, pharmacology, clinical efficacy and toxicity of satralizumab shortly after its approval for therapy of NMOSD; no mention of hepatotoxicity or ALT elevations). - PMC - PubMed

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[1] FDA. Clinical Review. 2020.

[2] FDA. Clinical Review. 2020.

[3] https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000M... [ (FDA Summary of the data the safety and efficacy of satralizumab, submitted in support of the application for approval as therapy of neuromyelitis optica spectrum disorder, mentions ALT elevations in 19.5% to 36.5% [none above 5 times ULN] of satralizumab-treated versus 12.5% to 14.5% on placebo and bilirubin elevations in 8% to 12% vs none with placebo, but there were no ALT elevations accompanied by jaundice). ]

[4] https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761149Orig1s000M... [ (FDA Summary of the data the safety and efficacy of satralizumab, submitted in support of the application for approval as therapy of neuromyelitis optica spectrum disorder, mentions ALT elevations in 19.5% to 36.5% [none above 5 times ULN] of satralizumab-treated versus 12.5% to 14.5% on placebo and bilirubin elevations in 8% to 12% vs none with placebo, but there were no ALT elevations accompanied by jaundice). ]

[5] Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381:2114-2124.(Among 83 patients with NMOSD treated with satralizumab or placebo for an average of 2 years, relapses occurred I 20% vs 43% while adverse event rates were similar [95% vs 90%] including severe adverse events [17% vs 21%]; no mention of ALT elevations or hepatotoxicity). - PubMed

[6] Yamamura T, Kleiter I, Fujihara K, Palace J, Greenberg B, Zakrzewska-Pniewska B, Patti F, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381:2114-2124.(Among 83 patients with NMOSD treated with satralizumab or placebo for an average of 2 years, relapses occurred I 20% vs 43% while adverse event rates were similar [95% vs 90%] including severe adverse events [17% vs 21%]; no mention of ALT elevations or hepatotoxicity). - PubMed

[7] Traboulsee A, Greenberg BM, Bennett JL, Szczechowski L, Fox E, Shkrobot S, Yamamura T, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19:402-412.(Among 95 patients with NMOSD treated with satralizumab or placebo, relapse rates were 30% vs 50% while adverse event rates were higher with monoclonal therapy [92% vs 75%] and serious adverse events [27% vs 6%] but there were no differences in rates of serious infections or injection reactions, and no anaphylactic reactions; no mention of ALT elevations or hepatotoxicity). - PMC - PubMed

[8] Traboulsee A, Greenberg BM, Bennett JL, Szczechowski L, Fox E, Shkrobot S, Yamamura T, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19:402-412.(Among 95 patients with NMOSD treated with satralizumab or placebo, relapse rates were 30% vs 50% while adverse event rates were higher with monoclonal therapy [92% vs 75%] and serious adverse events [27% vs 6%] but there were no differences in rates of serious infections or injection reactions, and no anaphylactic reactions; no mention of ALT elevations or hepatotoxicity). - PMC - PubMed

[9] Heo YA. Satralizumab: first approval. Drugs. 2020;80:1477-1482.(Review of the mechanism of action, pharmacology, clinical efficacy and toxicity of satralizumab shortly after its approval for therapy of NMOSD; no mention of hepatotoxicity or ALT elevations). - PMC - PubMed

[10] Heo YA. Satralizumab: first approval. Drugs. 2020;80:1477-1482.(Review of the mechanism of action, pharmacology, clinical efficacy and toxicity of satralizumab shortly after its approval for therapy of NMOSD; no mention of hepatotoxicity or ALT elevations). - PMC - PubMed

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Satralizumab

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