Kineret (Anakinra)

Anakinra (Kineret) blocks interleukin-1 (IL-1), a protein that plays an important role in promoting inflammation and immune system cell function in RA. It is manufactured by Swedish Orphan Biovitrum AB and is indicated (approved for treatment) for reducing the signs and symptoms of RA and slowing the progression of structural damage in moderately- to severely-active RA in adult patients who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs). It is also indicated for the treatment of cryopyrin-associated periodic syndromes, a group of rare autoimmune diseases.

 

Anakinra (Kineret): overview and efficacy

Anakinra (Kineret) blocks interleukin-1 (IL-1), a protein that plays an important role in promoting inflammation and immune system cell function in RA. It is manufactured by Swedish Orphan Biovitrum AB and is indicated (approved for treatment) for reducing the signs and symptoms of RA and slowing the progression of structural damage in moderately- to severely-active RA in adult patients who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs). It is also indicated for the treatment of cryopyrin-associated periodic syndromes, a group of rare autoimmune diseases.1

 

How is Kineret taken?

Kineret is taken by subcutaneous (under the skin) injection. The recommended dose in RA is 100 mg daily, with administration at approximately the same time every day.1

Make sure you have been instructed on how to prepare and give an injection of Kineret before you do it yourself. If you have any questions about how to prepare and administer Kineret, call your doctor. Before you administer Kineret, read the booklet “Instructions for Use” that comes with Kineret.1

 

How does Kineret work?

Kineret blocks interleukin-1 (IL-1), a protein that plays an important role in promoting inflammation and immune system cell function in RA. Kineret blocks the biologic activity of IL-1 (two types of IL-1, IL-1α and IL-1β) by binding to IL-1 receptors and keeping IL-1 itself from binding to those receptors. This keeps IL-1 from acting normally to support the immune cell functions and promote inflammation.1

 

Are there patients who should not take Kineret?

Kineret should not be taken by patients who are hypersensitive (allergic) to Kineret or any of its components. There is an increased risk for serious infections with Kineret. This is because Kineret can decrease the ability of the immune system to fight infections. If you are taking Kineret and you develop a serious infection, contact your doctor immediately and discontinue the drug. Also, you should not start Kineret if you have an active infection.1

Kineret is a pregnancy category B drug. In animal studies, there was no evidence that Kineret resulted in risk to the fetus. However, there have been no well-controlled studies in pregnant women. Kineret should only be used in pregnant women if clearly needed.

It is unknown whether Kineret is excreted into human milk. Because of the potential for adverse effects to the nursing infant, Kineret should be used with caution in nursing women.1

 

What evidence is there that Kineret works in RA?

The effectiveness of Kineret in RA has been evaluated in three randomized, controlled trials conducted in a total of 1,790 adult patients with active RA.

In one study (Study 1), 899 patients who had active RA despite a stable dose of methotrexate were randomized to Kineret or placebo, in addition to continued treatment with methotrexate.

A second study (Study 2) was conducted in 419 patients with active RA despite a stable dose of methotrexate, randomizing patients to one of five Kineret doses or placebo, in addition to continued treatment with methotrexate.

A third study (Study 3) was conducted in 472 patients who had active RA but who had not received DMARD treatment in the 6 weeks prior to the study (patients had previously failed no more than 3 DMARDs or were DMARD-naive). Patients were randomized to Kineret or placebo.1

Disease activity and clinical response. In the three studies described above, patients who received Kineret were more likely to achieve ACR20, 50, or 70 response than those who received placebo. In the majority of patients who responded to Kineret, responses occurred within the first 12 weeks of the study.1

 

Rates of ACR responses from two clinical trials of Kineret

Study 1: Patients with inadequate response to methotrexat (MTX)

Study 3: Monotherapy in patients receiving no current DMARD treatment

Kineret 100 mg/day + MTX (N=250) Placebo + MTX (N=251) Kineret 75 mg/day (N=115) Kineret 150 mg/day (N=115) Placebo (N=119)
ACR20
Mo 3 34% 24% 33% 33% 23%
Mo 6 38% 22% 34% 43% 27%
AC50
Mo 3 13% 6% 10% 8% 5%
Mo 6 17% 8% 11% 19% 8%
ACR70
Mo 3 3% 0% 0% 0% 0%
Mo 6 6% 2% 1% 1% 1%

 

Radiographic progression. X-ray images of the hands and forefeet were taken at baseline, 6 months, and 1 year in Study 1 to evaluate the effect of Kineret on the progression of structural damage to joints. Kineret + methotrexate resulted in significantly less radiographic progression than placebo + methotrexate, with significant differences in Total Sharp Score (TSS) and the TSS components joint erosion and joint space narrowing.1

 

Radiographic changes over 1 year: Kineret + methotexate (MTX) versus placebo + MTX

Mean scores Kineret 100 mg every day + MTX (N=449) Placebo + MTX (N=450) P-value (significance Kineret + MTX vs placebo + MTX)
Total Sharp Score 1.7 2.6 <0.001
Erosion score 1.1 1.6 0.024
Joint space narrowing score 0.7 1.1 <0.001

 

Is there a generic form of Kineret?

There is no generic equivalent of Kineret.

Written by: Jonathan Simmons | Last reviewed: September 2013.
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