Use of il-1b binding antibodies for the treatment of alcoholic hepatitis

A technology for the use of alcoholic hepatitis, which is applied in the field of application of IL-1B binding antibody for the treatment of alcoholic hepatitis, and can solve the problems of high infection incidence and no survival advantage

Inactive Publication Date: 2020-06-19
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Currently, the recommended treatment option for alcoholic hepatitis includes prednisolone, but this option is associated with a risk of higher infection rates resulting in no survival advantage at 90 days

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example

[0185] A multicenter, double-blind, randomized (1:1), placebo-controlled trial evaluating the efficacy, safety, and tolerability of canakinumab in patients with alcoholic hepatitis

[0186] standard constrain

[0187] Patients with alcoholic hepatitis eligible for inclusion in this study must meet all of the following criteria:

[0188] Male and female patients aged 18 years or older at screening

[0189] Clinical alcoholic hepatitis at screening:

[0190] o Serum bilirubin >80 μmol / L

[0191] o History of alcohol overdose (>80g / day for men, >60g / day for women) within 6 weeks prior to Screening Visit

[0192] Admitted to hospital less than 4 weeks from baseline visit

[0193] mDF ≥ 32 and MELD ≤ 25 at baseline visit

[0194] · Written informed consent must be obtained prior to any assessment.

[0195] ·Women of childbearing potential must use an effective method of contraception

[0196] exclusion criteria

[0197] Alcohol abstinence > 6 weeks prior to randomization / ba...

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PUM

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Abstract

The present invention relates to a method for treating or alleviating the symptoms of alcoholic hepatitis in a subject, comprising administering gevokizumab or 2-5 mg of canakinumab per kg of body weight to a subject in need thereof.

Description

technical field [0001] The present disclosure relates to novel uses and dosage regimens of the IL-1β binding antibodies canaginumab and gevozizumab for treating or alleviating the symptoms of alcoholic hepatitis. Background technique [0002] Excessive alcohol consumption is a major cause of liver disease in the Western world. Although how alcohol damages the liver is not fully understood, chronic alcohol consumption leads to the secretion of pro-inflammatory cytokines, oxidative stress, lipid peroxidation, and acetaldehyde toxicity, leading to inflammation, apoptosis, and eventually fibrosis of hepatocytes. The three most recognized stages of alcoholic liver disease are alcoholic fatty liver or steatosis, alcoholic hepatitis, and alcoholic cirrhosis. At least 80% of heavy drinkers develop steatosis, 10%-35% develop alcoholic hepatitis, and approximately 10% develop cirrhosis. Alcoholic hepatic steatosis (also known as alcoholic fatty liver disease) consists of a single la...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P1/16
CPCA61K39/395A61P1/16A61K2039/505A61K2039/54A61K2039/545C07K16/245
Inventor S·姆波夫
Owner NOVARTIS AG
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