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Kineret® (anakinra) A biologic alternative
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Kineret® (anakinra) 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.
 
Kineret® has been associated with an increased incidence of serious infections (2%) vs. placebo (< 1%). Kineret® should be discontinued if a patient develops an infection, however most patients can continue taking Kineret® after their infection resolves. Kineret® should not be initiated in patients with active infections. Kineret® should not be used with
TNF-blocking agents such as etanercept, adalimumab, and infliximab.
A 7% rate of serious infections was observed in a 24-week study of concurrent administration of Kineret® and etanercept.

Kineret® is contraindicated in patients with known hypersensitivity to
E coli-derived proteins, Kineret®, or any components of the product.

Percent of RA Patients Reporting Adverse Events with a Frequency of ≥ 5% In Kineret®-treated Patients Over a 6-month Period in Clinical Trials

Placebo
 Kineret®
100 mg/day
Preferred Term (n = 733) (n = 1565)
Injection-Site Reaction 29% 71%
Worsening of RA 29% 19%
URI 17% 14%
Headache 9% 12%
Nausea 7% 8%
Diarrhea 5% 7%
Sinusitis 7% 7%
Arthralgia 6% 6%
Flu-Like Symptoms 6% 6%
Abdominal Pain 5% 5%


Adverse events included those that were observed for patients in 2 clinical trials of Kineret® who received 100mg/day fixed dose. Patients in one study (N = 899) were on stable doses of methotrexate. Patients in the second study (N = 1399) included those who were on a variety of RA medications including some DMARD therapies and those who were DMARD-free.

The most common side effect of Kineret® in clinical trials was injection site reaction (ISR) which was usually mild, characterized by redness, swelling, and pain, and lasted for 14 to 28 days. The development of ISRs in patients who had not previously experienced them was uncommon after the first month of therapy.
   
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Kineret® (anakinra) 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.

In clinical trials, there was a risk of serious infections (2% in Kineret® patients vs. less than 1% in placebo patients). Kineret® should be discontinued if a patient develops an infection, however most patients can continue taking Kineret® after their infection resolves. Kineret® should not be used with TNF-blocking agents such as etanercept, adalimumab, and infliximab. A 7% rate of serious infections was observed in a 24-week study of concurrent administration of Kineret® and etanercept. Kineret® is contraindicated in patients with known hypersensitivity to E coli-derived proteins, Kineret®, or any components of the product. The most common side effect in clinical trials was injection site reaction, which was usually mild and characterized by redness, swelling, and pain.
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