This article is part of the Arthritis Archives.
Dateline: November 18, 2001
Kineret (Anakinra) FDA Approved
Kineret (anakinra) was approved by the United States Food and Drug Administration (FDA) on November 14, 2001, for rheumatoid arthritis patients who have failed one or more disease-modifying anti-rheumatic drugs (DMARDs).
Kineret (generic name anakinra) is the first selective blocker of interleukin-1 (IL-1), a protein which is found in excess in rheumatoid arthritis patients. By blocking IL-1, Kineret inhibits inflammation and pain associated with rheumatoid arthritis. Kineret can be used alone, or in combination with DMARDs other than anti-TNF drugs such as Enbrel (etanercept) and Remicade (infliximab).
Trial Results
As always, approval of a new drug is based on clinical trial results. 2,932 patients were involved in randomized, double-blinded, placebo-controlled clinical trials of Kineret. Of the trial participants, more than 2,600 were treated with Kineret. A clinical response indicative of diminished pain and inflammation was observed by the fourth week of treatment, while most were observed by week 13.
After 6 months of therapy, 38 percent of Kineret patients as compared to 22 percent of patients taking placebo achieved a 20 percent improvement in symptoms per American College of Rheumatology criteria (ACR20). ACR20 criteria include:
- 20 percent improvement in number of tender and swollen joints
- Greater than or equal to 20 percent improvement in at least 3 of the 5 following criteria:
- physician assessment of disease
- patient assessment of disease
- C-reactive protein
- pain
- health assessment questionnaire
The Associated Press quotes the FDA as saying that 2/3 of anti-TNF patients improve. Anti-TNF patients include those on either Remicade or Enbrel. Kineret, comparatively, is expected to offer modest effectiveness.
Kineret will hit pharmacy shelves within two weeks. The cost is expected to be $11,088/year according to its manufacturer Amgen.
The main side effect observed was injection site irritation. Since the drug suppresses the immune system, there exists a small risk of serious infection (2% of Kineret patients vs. less than 1% of placebo patients). Patients who do develop an infection should stop Kineret, but can resume once the infection is clear.
Amgen plans to market the drug to about 300,000 patients with moderate to severe rheumatoid arthritis who have failed traditional treatments. Beyond that, doctors will be assessing their patients, deciding which ones are potential candidates for Kineret and likely to benefit from it.
Related Resources
Sources: FDA Approves Kineret For Treatment Of RA, PRESS RELEASE, 11/14/01; FDA Approves Amgen's RA Drug, Reuters, 11/14/01;
FDA OKs New RA Drug, AP, Lauran Neergaard, 11/14/01
First published: 11/18/2001
