Kineret (anakinra)
An approved treatment for Systemic Juvenile Idiopathic Arthritis.
The same compound appears under different names depending on the context. Here is how to identify Anakinra wherever you encounter it, plus the key facts at a glance.
- Generic name
- Anakinra
- Brand name
- Kineret
- Drug class
- IL-1 receptor antagonist
- Manufacturer
- Sobi (Swedish Orphan Biovitrum)
- How it's taken
- Given as a daily subcutaneous injection (under the skin).
A recombinant IL-1 receptor antagonist that mimics the body's natural anti-inflammatory protein. While not FDA-approved for systemic JIA, anakinra is widely used off-label as a first-line agent due to its rapid onset of action (often within hours) and approximately 90% response rate. FDA-approved for rheumatoid arthritis, neonatal-onset multisystem inflammatory disease (NOMID, a form of CAPS), and deficiency of IL-1 receptor antagonist (DIRA).
Where Anakinra fits
Widely used as a first-line therapy for sJIA despite lacking FDA approval for this indication, based on approximately 90% response rates and rapid onset within hours. The 2013 ACR guidelines recommend anakinra as first-line for sJIA. Daily injections are less convenient than monthly canakinumab but the rapid onset makes anakinra invaluable for acutely ill patients and for MAS. Alongside canakinumab and tocilizumab (Actemra), anakinra is one of three biologic options for sJIA. For MAS complications, emapalumab (Gamifant) is now available as the first approved MAS-specific therapy. Also FDA-approved for adults with rheumatoid arthritis, for NOMID (a form of cryopyrin-associated periodic syndromes, or CAPS), and for DIRA.
How Anakinra works
Your body naturally produces a protein called IL-1 receptor antagonist (IL-1Ra) that acts as a brake on IL-1-driven inflammation. In systemic JIA, the immune system overwhelms this natural brake, producing far more IL-1 than the body's IL-1Ra can handle. Anakinra is a synthetic copy of IL-1Ra that floods the system with additional braking molecules.
Anakinra works by physically occupying the IL-1 receptor on cell surfaces, preventing both IL-1α and IL-1β from docking and delivering their inflammatory signal. Because it blocks the receptor itself (rather than just one form of IL-1), anakinra provides broader IL-1 pathway suppression than canakinumab, which only targets IL-1β.
The clinical effect in sJIA is often dramatic: fevers and systemic symptoms can resolve within hours of the first injection. This rapid onset makes anakinra particularly valuable for critically ill patients, including those developing macrophage activation syndrome. Despite lacking FDA approval for sJIA, it is recommended as a first-line agent by the 2013 ACR guidelines based on strong clinical evidence.
Mechanism: Recombinant human interleukin-1 receptor antagonist (IL-1Ra) that competitively blocks both IL-1α and IL-1β from activating IL-1 receptors, suppressing the inflammatory cascade
Side effects and safety
The most common side effect is injection site reactions (redness, pain, itching, and bruising), which affect most patients initially but typically resolve after 1-2 weeks of daily injections. Headaches, nausea, and mild infections (upper respiratory tract infections) can occur. Low white blood cell counts (neutropenia) are possible and require monitoring. Anakinra should not be combined with other biologic immunosuppressants due to increased infection risk. Serious infections can happen, so it should not be started during an active infection, and doctors should check for tuberculosis before treatment. Serious allergic reactions, including anaphylaxis, and severe skin reactions such as DRESS (a drug rash that can also affect internal organs) have been reported, including in people with autoinflammatory diseases; get help right away for a spreading rash, fever, swelling, or trouble breathing. The label also warns not to get live vaccines during treatment and to rotate injection sites, because protein (amyloid) deposits have formed at sites used over and over.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Anakinra
Given as a daily subcutaneous injection (under the skin). The standard dose for rheumatoid arthritis is 100 mg daily. For systemic JIA (off-label), dosing is typically weight-based at 1-2 mg/kg/day. The injection is given at approximately the same time each day and can be self-administered at home after training.
Availability and cost
Only available as the brand-name product.
Help paying for Kineret
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Commercially insured patients may pay as little as $0 per prescription, up to $13,000 per calendar year. Medicare, Medicaid, TRICARE and other government plans excluded.
For: private insurance · source - Free medicine program
KINERET Patient Assistance Program provides Kineret at no cost to patients who meet program eligibility requirements.
The official page does not say who qualifies. Ask the program. · source - Bridge or quick-start supply
QuickStart gives new patients a limited free supply during insurance delays; Bridge Program covers eligible patients with a gap in coverage.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
Insurance coverage and financial assistance information, specialty pharmacy triage, and nurse injection training if ordered.
The official page does not say who qualifies. Ask the program. · source
Good to know: Kineret's US label (per kineretrx.com) covers RA, NOMID and DIRA; sJIA is not a labeled use. Eligibility rules for the free-drug program are not listed on the site.
- From a charity · The Assistance FundJuvenile Arthritis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
Anakinra's evidence in sJIA comes primarily from clinical experience and observational studies rather than formal Phase 3 trials. A chart review of 46 sJIA cases found that first-line anakinra therapy produced rapid resolution of systemic symptoms and prevention of refractory arthritis in approximately 90% of patients. The 2013 ACR Pediatric JIA Guidelines recommend anakinra as a first-line agent for sJIA based on this clinical evidence. Multiple case series confirm rapid onset of action within hours.
Development history
Anakinra was developed as a recombinant form of the natural human IL-1 receptor antagonist and received FDA approval for rheumatoid arthritis in 2001. Early clinical experience in sJIA demonstrated remarkable speed and efficacy. The 2012 FDA approval for CAPS (neonatal-onset multisystem inflammatory disease) and later for DIRA (deficiency of IL-1 receptor antagonist) expanded its rare disease applications. Sobi acquired the product and continues marketing it globally. Despite lacking formal sJIA approval, it remains one of the most widely used first-line treatments for the condition.
Explore Systemic Juvenile Idiopathic Arthritis trials
Other Systemic Juvenile Idiopathic Arthritis treatments
Common questions about Anakinra
▸What is Anakinra (Kineret)?
A recombinant IL-1 receptor antagonist that mimics the body's natural anti-inflammatory protein. While not FDA-approved for systemic JIA, anakinra is widely used off-label as a first-line agent due to its rapid onset of action (often within hours) and approximately 90% response rate. FDA-approved for rheumatoid arthritis, neonatal-onset multisystem inflammatory disease (NOMID, a form of CAPS), and deficiency of IL-1 receptor antagonist (DIRA).
▸How does Anakinra work?
Your body naturally produces a protein called IL-1 receptor antagonist (IL-1Ra) that acts as a brake on IL-1-driven inflammation. In systemic JIA, the immune system overwhelms this natural brake, producing far more IL-1 than the body's IL-1Ra can handle. Anakinra is a synthetic copy of IL-1Ra that floods the system with additional braking molecules.
Anakinra works by physically occupying the IL-1 receptor on cell surfaces, preventing both IL-1α and IL-1β from docking and delivering their inflammatory signal. Because it blocks the receptor itself (rather than just one form of IL-1), anakinra provides broader IL-1 pathway suppression than canakinumab, which only targets IL-1β.
The clinical effect in sJIA is often dramatic: fevers and systemic symptoms can resolve within hours of the first injection. This rapid onset makes anakinra particularly valuable for critically ill patients, including those developing macrophage activation syndrome. Despite lacking FDA approval for sJIA, it is recommended as a first-line agent by the 2013 ACR guidelines based on strong clinical evidence.
▸What are the side effects of Anakinra?
The most common side effect is injection site reactions (redness, pain, itching, and bruising), which affect most patients initially but typically resolve after 1-2 weeks of daily injections. Headaches, nausea, and mild infections (upper respiratory tract infections) can occur. Low white blood cell counts (neutropenia) are possible and require monitoring. Anakinra should not be combined with other biologic immunosuppressants due to increased infection risk. Serious infections can happen, so it should not be started during an active infection, and doctors should check for tuberculosis before treatment. Serious allergic reactions, including anaphylaxis, and severe skin reactions such as DRESS (a drug rash that can also affect internal organs) have been reported, including in people with autoinflammatory diseases; get help right away for a spreading rash, fever, swelling, or trouble breathing. The label also warns not to get live vaccines during treatment and to rotate injection sites, because protein (amyloid) deposits have formed at sites used over and over.
▸How is Anakinra taken?
Given as a daily subcutaneous injection (under the skin). The standard dose for rheumatoid arthritis is 100 mg daily. For systemic JIA (off-label), dosing is typically weight-based at 1-2 mg/kg/day. The injection is given at approximately the same time each day and can be self-administered at home after training.
▸Is Anakinra FDA approved?
Yes, Anakinra (Kineret) is FDA approved (2001) for the treatment of Systemic Juvenile Idiopathic Arthritis.
▸Is anakinra FDA-approved for systemic JIA?
No. Anakinra (Kineret) is FDA-approved for rheumatoid arthritis, NOMID (a form of CAPS), and DIRA but is widely used off-label for systemic JIA. The 2013 ACR guidelines recommend it as a first-line therapy based on approximately 90% response rates in clinical practice.
▸How fast does anakinra work for sJIA fevers?
Anakinra can resolve sJIA fevers within hours of the first injection, making it one of the fastest-acting treatments available. This rapid onset is especially valuable for critically ill patients and those developing macrophage activation syndrome.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. Food and Drug Administration. KINERET (anakinra) Label. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d9d74915-6606-4570-9c52-c4001d3177de
- American College of Rheumatology. 2013 Update of the American College of Rheumatology Recommendations for the Treatment of JIA. https://rheumatology.org/patients/anakinra-kineret
- Swedish Orphan Biovitrum (Sobi). Kineret (anakinra). https://www.kineretrx.com