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Kineret (Anakinra) - Summary

 



KINERET SUMMARY

Kineret® (anakinra) is a recombinant, nonglycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra). Kineret® differs from native human IL-1Ra in that it has the addition of a single methionine residue at its amino terminus.

Kineret® is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). Kineret® can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents (see WARNINGS).


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NEWS HIGHLIGHTS

Media Articles Related to Kineret (Anakinra)

Adeona Announces Publication Of Results Of 160 Patient Phase 2 Clinical Trial Of Oral DnaJP1 For Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.15]
Adeona Pharmaceuticals, Inc. (AMEX: AEN) announced the publication in the journal Arthritis & Rheumatism of results of a 160-patient, six-month, double-blind, placebo-controlled Phase 2 clinical trial using the company's oral dnaJP1 for the treatment of rheumatoid arthritis (RA). The results of the study were originally presented at the 2008 American College of Rheumatology Annual Meeting. The study was sponsored by the National Institutes of Health (NIH).

Judgement In Favour Of NICE On Judicial Review Of Abatacept For Rheumatoid Arthritis Guidance
Source: Arthritis / Rheumatology News From Medical News Today [2009.11.10]
The High Court has ruled in favour of NICE by dismissing the application from Bristol Myers Squibb (BMS), the manufacturer of abatacept, for a judicial review of the NICE guidance on the use of abatacept for the treatment of rheumatoid arthritis. In April 2008, NICE published final guidance which did not recommend abatacept as a treatment option for people with rheumatoid arthritis.

How Rheumatoid Arthritis Spreads
Source: MedicineNet Rheumatoid Arthritis Specialty [2009.11.10]
Title: How Rheumatoid Arthritis Spreads
Category: Health News
Created: 11/10/2009 9:50:00 AM
Last Editorial Review: 11/10/2009 9:50:12 AM

Rheumatoid Arthritis Treatment Doesn't Promote Cancer (HealthDay)
Source: Y! Health Arthritis News [2009.10.29]
HealthDay - THURSDAY, Oct. 29 (HealthDay News) -- Treatment with tumor necrosis factor (TNF) blockers doesn't increase rheumatoid arthritis patients' risk of cancer, new research has found.

Advancing Personalized Medicine In Rheumatoid Arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2009.10.26]
The University of Alabama at Birmingham (UAB) is spearheading an effort to create a national database and repository to enable researchers to identify predictors of effectiveness of various treatments for rheumatoid arthritis (RA). RA is the most common type of inflammatory arthritis. Many effective medications exist, but they vary greatly in cost and side effects, and there is no way to predict which drug will work best on an individual. A two-year, $3.

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Published Studies Related to Kineret (Anakinra)

Intraarticular injection of anakinra in osteoarthritis of the knee: a multicenter, randomized, double-blind, placebo-controlled study. [2009.03.15]
OBJECTIVE: To evaluate the clinical response, safety, and tolerability of a single intraarticular injection of anakinra in patients with symptomatic osteoarthritis (OA) of the knee... CONCLUSION: Anakinra was well tolerated as a single 50-mg or 150-mg intraarticular injection in patients with OA of the knee. However, anakinra was not associated with improvements in OA symptoms compared with placebo.

Anakinra in the treatment of polyarticular-course juvenile rheumatoid arthritis: safety and preliminary efficacy results of a randomized multicenter study. [2009.02]
This study assessed the safety and preliminary efficacy of the interleukin-1 receptor antagonist anakinra in patients with polyarticular-course juvenile rheumatoid arthritis (JRA). Eighty-six patients entered a 12-week open-label run-in phase (1 mg/kg anakinra daily, < or =100 mg/day)... These results indicate that anakinra 1 mg/kg once daily (< or =100 mg/day) is safe and well tolerated in patients with JRA.

Anakinra for rheumatoid arthritis. [2009.01.21]
CONCLUSIONS: Anakinra is a relatively safe and modestly efficacious biologic therapy for rheumatoid arthritis. Although head to head comparison trials have not been carried out, the amount of improvement is notably less when compared to studies using other biologic therapies. More studies are needed to evaluate safety and efficacy, especially in comparison to other therapies, and adverse event data for the long-term use of Anakinra has yet to be assessed.

Safety of extended treatment with anakinra in patients with rheumatoid arthritis. [2006.08]
OBJECTIVE: To determine the safety profile of anakinra after extended exposure in a diverse clinical trial population of patients with rheumatoid arthritis... CONCLUSION: Anakinra is safe and well tolerated for up to three years of continuous use in a diverse population of patients with rheumatoid arthritis.

A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. [2004.09]
OBJECTIVE: To assess the efficacy and safety of 100 mg daily anakinra (Kineret), a recombinant form of the naturally occurring interleukin 1 receptor antagonist, plus methotrexate (MTX) in reducing the signs and symptoms of rheumatoid arthritis (RA)... CONCLUSIONS: This study confirms previous observations from a dose-ranging study showing that anakinra, in combination with MTX, is an effective and safe treatment for patients with RA who have inadequate responses to MTX alone.

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Clinical Trials Related to Kineret (Anakinra)

The Use of Kineret (Anakinra) in the Treatment of Familial Cold Urticaria [Completed]
An open labelled trial of Kineret (anakinra) induction therapy (100mg./day) in over a four week period in the treatment of Familial Cold Urticaria.

Familial Cold Urticaria (FCU) is a rare autosomal dominant condition manifesting symptoms triggered by exposure to cold and variable in expression. Currently there is no standard reliable agent available for the treatment of patients with FCU. This study will evaluate the efficacy of Kineret (anakinra), an interleukin 1 receptor antagonist in induction and maintenance therapy in patients with FCU.

Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA) [Completed]
The purpose of this study is to evaluate the percentage of subjects in Australian clinical practice continuing treatment with Anakinra (Kineret®) at the end of study week 48 in subjects with active RA. The continued use of Kineret® will be based on pre-defined response assessment criteria for subjects with active RA.

Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire [Completed]
The primary purpose of this study is to assess the ease-of-use of SimpleJectTM compared to pre-filled syringe(s) when using Kineret® in RA subjects. The secondary purpose of this study is to assess the level of fear and anxiety associated with the use of both injection methods, to assess safety when using SimpleJectTM and to evaluate the Ease-of-Administration Questionnaire (EAQ) in terms of the quality of items, item performance, and the instrument reliability.

Anti-Inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes [Enrolling by invitation]
The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity.

Anakinra With or Without Dexamethasone in Treating Patients With Smoldering or Indolent Multiple Myeloma [Active, not recruiting]
RATIONALE: Some cancers need growth factors which are made by the body's white blood cells to keep growing. Anakinra may interfere with the growth factor and stop multiple myeloma from growing. Dexamethasone may stop cancer cells from growing. Giving anakinra together with dexamethasone may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well anakinra works when given with or without dexamethasone in treating patients with smoldering myeloma or indolent multiple myeloma.

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Page last updated: 2009-11-15

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