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Compositions and methods for treating lupus nephritis

A technology for lupus nephritis and lupus, applied in the field of compositions and methods for treating lupus nephritis, capable of solving problems such as unimproved clinical results

Pending Publication Date: 2022-04-12
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, after 1 year of rituximab treatment, clinical outcomes did not improve

Method used

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  • Compositions and methods for treating lupus nephritis
  • Compositions and methods for treating lupus nephritis
  • Compositions and methods for treating lupus nephritis

Examples

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example

[0353] The present invention will be more fully understood by reference to the following examples. However, they should not be construed as limiting the scope of the invention. It should be understood that the examples and embodiments described herein are for illustrative purposes only, and that various modifications or changes thereof will be suggested to those skilled in the art, and will be included within the spirit and scope of this application and the scope of the appended claims. within range.

example 1

[0354] Example 1: Obinutuzumab plus mycophenolate mofetil and corticosteroids in the treatment of proliferative lupus nephritis

[0355] B cells are central to the pathogenesis of lupus nephritis, but randomized controlled trials of type I anti-CD20 antibodies have failed to demonstrate superiority to standard of care alone. Obinutuzumab, a glycoengineered type II anti-CD20 monoclonal antibody, induces greater B cell depletion compared with type I anti-CD20 antibodies. Obinutuzumab was compared with placebo treatment in patients with proliferative lupus nephritis treated with mycophenolate mofetil and corticosteroids.

[0356] Obinutuzumab was compared with placebo in a phase 2, multicenter, randomized, double-blind trial (NOBILITY) in patients with proliferative lupus nephritis treated with mycophenolate mofetil and corticosteroids. The efficacy of the drug, the results are as follows.

[0357] Materials and Methods

[0358] 126 patients were enrolled at 43 sites in Nort...

example 2

[0436] Example 2: A Modified Obinutuzumab Dosing Regimen for Combining Mycophenolate Mofetil and Corticosteroids in the Treatment of Proliferative Lupus Nephritis.

[0437] The study described in Example 1 showed that a dosing regimen of obinutuzumab infused at 1000 mg at weeks 0, 2, 24, and 26 in combination with standard-of-care immunosuppression demonstrated that at weeks 52 and 76 It will have curative effect and acceptable safety in patients with lupus nephritis (LN). This example describes how a modeling approach was used to predict the expected obinutuzumab following a 1000 mg dosing regimen combined with mycophenolate mofetil and a corticosteroid infusion at weeks 0, 2, 24, 26, and 52. Anti-PK.

[0438] Population Pharmacokinetic Model

[0439] Based on the data presented in Example 1 a population pharmacokinetic (PK) model was developed. The analytical data set used to develop the PK model included 658 obinutuzumab post-dose serum concentration values ​​from 63 pat...

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Abstract

The present disclosure provides methods for treating lupus nephritis in an individual having lupus. In some embodiments, the methods comprise administering to the individual an effective amount of a type II anti-CD20 antibody. In other aspects, the disclosure provides methods for treating membranous nephropathy.

Description

[0001] Cross References to Related Applications [0002] This application asserts U.S. provisional applications 62 / 899,706 filed September 12, 2019; 62 / 930,527 filed November 4, 2019; 62 / 931,032 filed November 5, 2019; and April 3, 2020 Priority of application 63 / 005,071; both incorporated herein by reference in their entirety. [0003] Submit the sequence listing as an ASCII text file [0004] The submission of the following ASCII text document is hereby incorporated by reference in its entirety: Computer Readable Form (CRF) of the Sequence Listing (Filename: 146392048341SEQLIST.TXT, Date of Record: August 17, 2020, Size: 37KB). technical field [0005] Provided herein are methods for treating lupus nephritis (LN) in an individual with lupus by administering a type II anti-CD20 antibody. In other aspects, provided herein are methods for treating membranous nephropathy. Background technique [0006] Proliferative lupus nephritis is the most common organ-at-risk manifestat...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K45/06C07K16/28A61P13/12A61P37/06
CPCC07K16/2887C07K2317/73C07K2317/565A61K39/39541A61K2039/505A61K2039/545A61P37/06A61P13/12A61K31/365A61K31/5377A61K31/573A61K31/138A61K31/167A61K45/06C07K2317/24C07K2317/40A61K31/34
Inventor M·D·卡西诺
Owner F HOFFMANN LA ROCHE & CO AG
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