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Multiple-variable dose regimen for treating TNFa-related disorders

a multi-variable, dose regimen technology, applied in immunological disorders, antibody medical ingredients, peptide/protein ingredients, etc., can solve the problems of difficult crohn's disease treatment, significant side effects, and current compounds and regimens that do not completely abate the inflammatory process, so as to improve the treatment of tnfa-related disorders.

Inactive Publication Date: 2009-12-10
ABBVIE BIOTECHNOLOGY LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0049]In one embodiment, the label of the invention indicates that the TNFα inhibitor, e.g., TNFα antibody, e.g., adalimumab, may be used to treat Crohn's disease in patients who have had an inadequate response to conventional therapy and / or who have lost response to or are intolerant to infliximab. In another embodiment, the label of the invention indicates the TNFα inhibitor is also indicated for treatment in adult patients with moderately to severely active Crohn's disease who have lost response to or are intolerant to infliximab. In another embodiment, the label of the invention indicates that the TNFα inhibitor, e.g., TNFα antibody, e.g., adalimumab, may be used for reducing signs and symptoms and inducing remission in patients who have lost response to or are intolerant to infliximab.

Problems solved by technology

Other systemic therapy, such as methotrexate cyclosporine and synthetic retinoids are effective, but are often administered in rotation due to their possible cumulative toxic effect.
The treatment of Crohn's disease is challenging.
Current compounds and regimens do not completely abate the inflammatory process and have significant side effects.

Method used

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

Examples

Experimental program
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Effect test

example 1

Study of Efficacy of Multiple-Dose Therapy for Treatment of Crohn's Disease

[0468]Multiple-Variable Dose Treatment of Crohn's Disease (CD) with D2E7 (Adalimumab)

[0469]Studies were performed to determine the efficacy of a multiple-variable dose regimen of a TNFα inhibitor, namely D2E7 (also referred to as adalimumab and Humira®), for treating Crohn's disease (CD). Efficacy and tolerability of D2E7 in the treatment of patients with active Crohn's disease were evaluated in the following randomized, double-blind, placebo-controlled, multicenter study. Another objective of the following study was to assess the pharmacokinetics of adalimumab (ADA or D2E7), a fully human monoclonal antibody recognizing TNF, following subcutaneous (sc) administration in patients with Crohn's disease. To assess the pharmacokinetics of adalimumab was determined, a fully human monoclonal antibody TNF-antagonist, following subcutaneous (sc) administration over 4 weeks in patients with CD who participated in this...

example 2

Additional Study of Efficacy of Multiple-Dose Therapy for Treatment of Crohn's Disease

[0486]Multiple-Variable Dose Treatment of Crohn's Disease with D2E7

[0487]A study was performed to assess the tolerability and clinical benefit of a multiple-variable dose treatment using a TNFα inhibitor, specifically D2E7, in adult patients with Crohn's disease who had previously received and responded to a different TNFα inhibitor. The study included patients who had previously received the chimeric anti-TNF antibody infliximab, but who no longer have a sustained response and / or tolerance to infliximab.

[0488]Patients who had lost responsiveness 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 subcutaneous. Antibodies to infliximab (ATI) were determined at baseline (Prometheus Laboratories, San Diego, Calif.). Crohn's disease activity index (CDAI) scores, presence of fistulas, and C-reactive protein (CRP)...

example 3

Efficacy of Multiple-Dose Therapy Using TNFα Inhibitor for Treatment of Psoriasis

[0491]Multiple-Variable Dose Treatment of Psoriasis with D2E7

[0492]A study was performed to determine the efficacy of a multiple-variable dose regimen of D2E7 for treating psoriasis. 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.

[0493]In this study, one hundred forty-eight adult patients with a diagnosis of moderate to severe psoriasis for at least one year were selected to receive multiple-variable dose treatment. Patients were also selected based on an affected body surface area (BSA) of ≧5%. Subjects were randomized equally to one of three groups (two treatment groups and one placebo).

[0494]At baseline (Week 0) patients in both treatment groups received an induction dose of 80 mg of D2E7. Patients in the first treatment group subsequently received a trea...

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Abstract

Multiple-variable dose methods for treating TNFα-related disorders, including Crohn's disease and psoriasis, comprising administering TNFα inhibitors, including TNFα 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

RELATED APPLICATIONS[0001]This application is a continuation of U.S. application Ser. No. 11 / 804,587, filed on May 17, 2007. U.S. application Ser. No. 11 / 804,587 is a continuation-in-part of U.S. application Ser. No. 11 / 104,117, filed on Apr. 11, 2005. U.S. application Ser. No. 11 / 104,117 claims the benefit of priority to U.S. Provisional Application No. 60 / 561,139, filed Apr. 9, 2004; U.S. Provisional Application No. 60 / 561,710, filed Apr. 12, 2004; and U.S. Provisional Application No. 60 / 569,100, filed May 7, 2004. U.S. application Ser. No. 11 / 804,587 claims the benefit of priority to U.S. Provisional Application No. 60 / 801,584, filed on May 17, 2006; U.S. Provisional Application No. 60 / 849,967, filed Oct. 6, 2006 and U.S. Provisional Application No. 60 / 918,174, filed Mar. 14, 2007. The entire contents of each of these patent applications are hereby incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Cytokines, such as interleukin-1 (IL-1) and tumor necrosis factor (...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K39/395C07K16/24A61K38/00A61P17/06A61P37/00
CPCA61K2039/505A61K2039/545C07K16/241A61K39/3955C07K2317/21C07K2317/56C07K2317/565C07K2316/96C07K2317/76A61K31/519A61P1/00A61P17/06Y02A50/30A61K9/0019C07K2317/24C07K2317/92
Inventor HOFFMAN, REBECCA S.CHARTASH, ELLIOT K.TAYLOR, LORI K.GRANNEMAN, GEORGE R.YAN, PHILIPPAULSON, SUSAN K.PENG, JOANNA Z.
Owner ABBVIE BIOTECHNOLOGY LTD
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