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Kineret (Anakinra) - 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 consists of 153 amino acids and has a molecular weight of 17.3 kilodaltons. It is produced by recombinant DNA technology using an E coli bacterial expression system. Kineret is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily subcutaneous (SC) administration. The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. Each prefilled glass syringe contains: 0.67 mL (100 mg) of anakinra in a solution (pH 6.5) containing disodium EDTA (0.12 mg), sodium chloride (5.48 mg), anhydrous citric acid (1.29 mg), and polysorbate 80 (0.70 mg) in Water for Injection, USP.

Active Rheumatoid Arthritis

Kineret is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), 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 and Precautions (5.2) ].

Cryopyrin-Associated Periodic Syndromes (CAPS)

Kineret is indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).

See all Kineret indications & dosage >>


Media Articles Related to Kineret (Anakinra)

Medical News Today: C-EARLY: certolizumab pegol effective in early rheumatoid arthritis
Source: Featured Health News from Medical News Today [2015.11.20]
A study presented at the American College of Rheumatology Annual Meeting suggests certolizumab pegol is beneficial for patients with early rheumatoid arthritis.

C-EARLY: certolizumab pegol effective in early rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2015.11.20]
A study presented at the American College of Rheumatology Annual Meeting suggests certolizumab pegol is beneficial for patients with early rheumatoid arthritis.

Filgotinib Shows Potential in Rheumatoid Arthritis
Source: Medscape Orthopaedics Headlines [2015.11.14]
Response to the Janus kinase 1 inhibitor was good in patients with rheumatoid arthritis who have highly active disease despite methotrexate therapy, new research showed.
Medscape Medical News

Detailed results demonstrate baricitinib superiority to adalimumab in improving signs and symptoms of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2015.11.12]
Eli Lilly and Company and Incyte Corporation have announced detailed data from the fourth Phase 3 study of baricitinib, RA-BEAM, at the American College of Rheumatology/Association of Rheumatology...

Rheumatoid Arthritis (RA)
Source: MedicineNet Amyloidosis Specialty [2015.11.12]
Title: Rheumatoid Arthritis (RA)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 11/12/2015 12:00:00 AM

more news >>

Published Studies Related to Kineret (Anakinra)

Effects of Prolastin C (Plasma-Derived Alpha-1 Antitrypsin) on the acute inflammatory response in patients with ST-segment elevation myocardial infarction (from the VCU-alpha 1-RT pilot study). [2015]
Alpha-1 antitrypsin (AAT) has broad anti-inflammatory and immunomodulating properties in addition to inhibiting serine proteases... In conclusion, a single administration of Prolastin C in patients with STEMI is well tolerated and is associated with a blunted acute inflammatory response.

Effects of interleukin-1 blockade with anakinra on aerobic exercise capacity in patients with heart failure and preserved ejection fraction (from the D-HART pilot study). [2014]
Heart failure with preserved ejection fraction (HFpEF) is a clinical syndrome of exercise intolerance due to impaired myocardial relaxation and/or increased stiffness. Patients with HFpEF often show signs of chronic systemic inflammation, and experimental studies have shown that interleukin-1 (IL-1), a key proinflammatory cytokine, impairs myocardial relaxation...

Treatment with Anakinra improves disposition index but not insulin sensitivity in nondiabetic subjects with the metabolic syndrome: a randomized, double-blind, placebo-controlled study. [2011.07]
CONTEXT: Obesity induces low-grade inflammation that may promote the development of insulin resistance. IL-1 is one of the key inflammatory factors. OBJECTIVE: The objective of the study was to demonstrate improvement of insulin sensitivity by blocking IL-1... CONCLUSIONS: Our results suggest that anakinra does not improve insulin sensitivity in obese, insulin-resistant, nondiabetic subjects.

A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial). [2011.05]
OBJECTIVES: To assess the efficacy of the interleukin 1 receptor antagonist anakinra in systemic-onset juvenile idiopathic arthritis (SJIA)... CONCLUSIONS: Anakinra treatment is effective in SJIA, at least in the short term. It is associated with normalisation of blood gene expression profiles in clinical responders and induces a de novo IFN signature. Trial Registration Number: NCT00339157.

Interleukin-1 blockade with anakinra to prevent adverse cardiac remodeling after acute myocardial infarction (Virginia Commonwealth University Anakinra Remodeling Trial [VCU-ART] Pilot study). [2010.05.15]
Acute myocardial infarction (AMI) initiates an intense inflammatory response in which interleukin-1 (IL-1) plays a central role...

more studies >>

Clinical Trials Related to Kineret (Anakinra)

A Pilot Study Using Anakinra/Kineret for the Treatment of Patients With Severe Atopic Dermatitis [Terminated]

- Severe atopic dermatitis, also known as eczema, is a chronic inflammatory skin

condition that affects both children and adults and causes severe itching and skin redness. Current treatments of atopic dermatitis include topical creams and lotions, light therapy, and medications. However, the difficulty with long-term treatment for the chronic and severe nature of the disease requires more effective and better-tolerated therapeutic options.

- Anakinra is a drug that blocks a substance called interleukin-1 (IL-1), which may be

important in causing the inflammation in atopic dermatitis. Researchers are interested in determining whether anakinra can be used to help treat atopic dermatitis. Anakinra has been approved by the Food and Drug Administration to treat rheumatoid arthritis in adults and children, but it has not been approved for use in adults or children with atopic dermatitis and is considered an experimental treatment in this study. In this study Anakinra will be administered as an injection under the skin every day for 3 months Objectives:

- To assess the safety and effectiveness of using anakinra to treat severe atopic dermatitis

in children. Eligibility:

- Children between 10 and 18 years of age who have been diagnosed with severe atopic

dermatitis that has not responded to standard treatment. Design:

- Initial Screening: Participants will have an initial screening visit with a complete

physical examination and medical history, blood and urine tests, photographs of the skin ,skin biopsy, and other tests as required.

- Run-in Period: At the screening visit, participants will receive a diary card and will

be asked to track their atopic dermatitis symptoms on standard treatment for 2 months.

- Start of Treatment: At the end of the 2 month Run-in period participants will return

for an inpatient visit (2 days) to receive the initial dose of anakinra and will be watched for any side effects. During the inpatient visit, participants will have additional examinations and blood and urine tests, and will be instructed on how to administer the anakinra injections at home.

Treatment Period: - Participants will return once a week for the first 2 weeks of treatment,

at the end of the first month, and then once a month for the following 2 months, for a physical exam and blood tests. Participants will be asked to record symptoms related to their atopic dermatitis, anakinra administration and any side effects related to the anakinra on the diary card. The diary cards will be reviewed and collected at each visit.- End of Treatment Period: At the end of 3 months of treatment with anakinra, participants will again be asked to record symptoms related to their atopic dermatitis on the diary card. Participants will be seen once a month for 3 months for a physical exam, blood tests and review of the diary card. . The final study visit will take place at the end of the 3rd month and will include a physical exam, blood tests, photographs and skin biopsy.

Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease [Recruiting]
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that may lead to complications later in life, including heart attack. Although the investigators can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Therefore, the investigators propose to study the safety and activity of anakinra in infants and children < 2 years old with coronary artery abnormalities from KD.

Anakinra or Denosumab and Everolimus in Advanced Cancer [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the combination of Afinitor (everolimus) either with Kineret (anakinra) or Xgeva (denosumab) that can be given to patients with advanced cancer. The safety of these drugs will also be studied. Everolimus is designed to stop cells from dividing. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and spread of cancer. Denosumab is designed to block the activity of a protein, which may prevent bone complications in cancer that has spread to the bone.

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.

more trials >>

Reports of Suspected Kineret (Anakinra) Side Effects

Pyrexia (8)Alanine Aminotransferase Increased (6)Rash (6)Dyspnoea (4)Vomiting (4)Cytolytic Hepatitis (4)Aspartate Aminotransferase Increased (4)Leukopenia (4)Liver Injury (3)Drug Ineffective (3)more >>

Page last updated: 2015-11-20

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