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Multiple-variable dose regimen for treating tnfalpha-related disorders

A dose and symptom technology, applied in the field of variable doses in the treatment of Crohn's disease, can solve the problem of inability to completely reduce inflammatory side effects

Inactive Publication Date: 2007-06-27
ABBVIE BIOTECHNOLOGY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Latest compounds and regimens fail to fully reduce inflammatory processes and have significant side effects

Method used

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  • Multiple-variable dose regimen for treating tnfalpha-related disorders
  • Multiple-variable dose regimen for treating tnfalpha-related disorders
  • Multiple-variable dose regimen for treating tnfalpha-related disorders

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0478] Example 1: Efficacy Study of Multiple Variable Dose Therapy for the Treatment of Crohn's Disease

[0479] Multiple-dose treatment approach for Crohn's disease using D2E7

[0480] A study was conducted to determine the TNFα inhibitor D2E7 (also known as Adalimumab and Humira  ) in the treatment of Crohn's disease. The efficacy and tolerability of D2E7 in the treatment of patients with acute Crohn's disease were evaluated in a randomized double-blind placebo-controlled multicenter study.

[0481] In this study, 299 TNF-antagonist naïve patients with active Crohn's disease were selected. Crohn's disease was confirmed in each patient by endoscopic or radiological evaluation. Subjects were randomly and equally assigned to one of 4 treatment groups (3 treatments and 1 placebo group). Eligible subjects included men and women aged 18-75 with a Crohn's disease diagnosis for more than 4 months. In addition, selected patients had active Crohn's disease, defined as a...

Embodiment 2

[0495] Example 2: Additional studies of the efficacy of multiple variable dose therapy for the treatment of Crohn's disease

[0496] Multiple-dose treatment approach for Crohn's disease using D2E7

[0497] A study was conducted to evaluate the tolerability and clinical benefit of multiple variable dose treatment with TNFα inhibitors, particularly D2E7, in adult patients with Crohn's disease who had previously received and responded to different TNFα inhibitors. Patients who had previously received the chimeric anti-TNF antibody infliximab but no longer had a sustained response and / or tolerance to infliximab were included in the study.

[0498] Patients who had become unresponsive or developed intolerance (acute or delayed infusion reactions) were treated with D2E7 80 mg at week 0 and 40 mg at week 2. All treatments were performed subcutaneously. Antibody to Infliximab (ATI) at baseline was determined (Prometheus Laboratories, San Diego, CA). Crohn's disease activity...

Embodiment 3

[0501] Example 3: Efficacy of multiple variable dose therapy with TNFα inhibitors in the treatment of psoriasis

[0502] Multiple-dose treatment approach for psoriasis using D2E7

[0503] A study was conducted to determine the efficacy of a multiple variable dosage regimen of D2E7 in the treatment of psoriasis. The efficacy and tolerability of D2E7 in the treatment of patients with moderate to severe chronic plaque psoriasis were evaluated in a randomized double-blind placebo-controlled multicenter study.

[0504] In this study, 148 adult patients diagnosed with moderate-to-severe psoriasis for at least 1 year were selected to receive multiple-variable dose therapy. Patients were also selected on the basis of > 5% body surface area (BSA) affected. Subjects were randomly and equally assigned to one of three groups (two treatment groups and one placebo group).

[0505] At baseline (week 0), patients in both treatment groups received an induction dose of 80 mg D2E7. ...

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Abstract

Multiple-variable dose methods for treating TNFa-related disorders, including Crohn's disease and psoriasis, comprising administering TNFa inhibitors, including TNFa antibodies, are described. Multiple-variable dose methods include administration of a TNF-inhibitor in an induction or loading phase followed by administration of the agent in a maintenance or treatment phase, wherein the TNF-inhibitor is administered in a higher dosage during the induction phase.

Description

[0001] related application [0002] This application claims the benefit of the following applications: U.S. Provisional Application US 60 / 561,139, filed April 9, 2004; U.S. Provisional Application US 60 / 561,710, filed April 12, 2004; and U.S. Provisional Application Application US 60 / 569,100. The entire contents of each of these patent applications are incorporated herein by reference. [0003] This application is related to US patents US 6,090,382, US 6,258,562 and US 6,509,015. This application is also related to US Patent Applications filed March 7, 2001; US ​​Patent Application US 10 / 302,356, filed November 22, 2003; US Patent Application US 10 / 163657, filed June 5, 2002; 2002 US Patent Application US10 / 133715, filed April 26; US Patent Application US 10 / 222140, filed August 16, 2002; US Patent Application US 10 / 693233, filed October 24, 2003; July 18, 2003 US Patent Application US 10 / 622932 filed on July 18, 2003; US Patent Application US 10 / 623039 filed on July 18, 200...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/40
Inventor R·S·霍夫曼E·查特斯L·K·泰勒G·R·格兰尼曼P·严
Owner ABBVIE BIOTECHNOLOGY LTD
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