IL-1 receptor antagonist

Kineret (anakinra)

An approved treatment for Systemic Juvenile Idiopathic Arthritis.

FDA Approved (2001)by Sobi (Swedish Orphan Biovitrum)

Preclinical

Phase 1

Phase 2

Phase 3

Approved

2001

Drug facts

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).

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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.

Side effects and safety

What patients report

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 100mg daily. For systemic JIA (off-label), dosing is typically weight-based at 1-2mg/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

No generic available

Only available as the brand-name product.

Help paying for Kineret

With private insurance, the drugmaker's copay card can lower what you pay for Kineret. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. The charity fund for Systemic Juvenile Idiopathic Arthritis was not taking new applications on November 13, 2026. Pick your insurance below to see which offers fit you.

Your insurance

From the drugmaker

Kineret (Anakinra)

Kineret ON TRACK

Official program page Call 1-866-547-0644

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.

Checked on the drugmaker's official pages on November 2, 2026. Programs change; confirm with the program before you rely on it.

Charity funds for Systemic Juvenile Idiopathic Arthritis

From a charity · The Assistance Fund
Juvenile Arthritis fund
Waitlist
Apply on the foundation’s page
Pays for: Copays, coinsurance, deductibles and other health-related expenses.

Status as each foundation showed it on November 13, 2026.

Every program and charity fund for Systemic Juvenile Idiopathic Arthritis →

More ways to get help paying for treatment →

Insurance said no? Your Insurer Denied a Rare Disease Drug and Fewer Than 1 in 100 People Appeal, So Here Is the Playbook · 14 min read

Anakinra treatment timeline for Systemic Juvenile Idiopathic Arthritis

Tap how long you have been on Anakinra to drop your pin on the road. Your answers stay on this device.

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Stage 1 of 5 · Start to 1 mo

Starting anakinra

Your child is starting anakinra (Kineret) for systemic JIA. Anakinra is not FDA-approved for sJIA, so using it here is off-label. The Kineret label also says its safety and effectiveness have not been established in juvenile rheumatoid arthritis, and its patient leaflet says it is not for children with that condition. Even so, it is widely used for sJIA. The 2026 ACR guidelines strongly recommend an IL-1 or IL-6 inhibitor as the first treatment for sJIA and name no preferred choice. Doctors often pick anakinra because it can work quickly. This speed makes anakinra especially valuable for acutely ill children and for those at risk of or actively experiencing macrophage activation syndrome (MAS). The tradeoff is the daily injection schedule, which can be challenging for children and families. The label gives no dose for sJIA. Your child's rheumatologist sets the dose, usually by body weight. Before starting, the doctor checks for tuberculosis (TB), as the Kineret label advises. Injection site reactions such as redness, pain, or itching are very common. In adult studies they usually started in the first 4 weeks and often lasted 2 to 4 weeks. Techniques that help with daily injections include: applying ice to the injection site for a few minutes beforehand to numb the skin, rotating injection sites (thighs, abdomen, upper arms), giving the injection at bedtime so your child sleeps through any site discomfort, and using distraction techniques during the injection. If your child is very ill, some rheumatologists use a higher dose based on their own experience. The label has no sJIA dose to compare with.

Coming up

Within the first few days, look for resolution of the quotidian (daily-cycling) fevers and rash. In one study of 46 children given anakinra first, fever and rash cleared within a month in more than 95% of them. If the fevers stop quickly, that is an excellent sign. Joint improvement may take longer. If your child was on steroids, the rheumatologist will likely begin tapering once the response is confirmed (usually within the first 1-2 weeks given how fast anakinra works). Labs are checked to confirm the inflammatory markers are dropping and neutrophil counts are acceptable, and the label advises neutrophil checks monthly for the first 3 months. If injection site reactions are severe, applying ice before injecting and rotating injection sites can help. Rotating sites also matters for another reason. The Kineret label added a 2025 warning that, in patients with another condition called NOMID who received high doses in the same skin area over long periods, protein deposits called amyloid formed at the injection site, and some of them developed protein in the urine. Some families find that giving the injection at bedtime reduces the child's awareness of injection site discomfort. Your child should not receive live vaccines while taking anakinra, so ask about timing for any vaccines.

Get in touch with your rheumatology team if you notice

Fevers that do not settle within the first few days of anakinra (call the rheumatologist, who may change the plan or recheck the diagnosis)
MAS symptoms: extreme fatigue, confusion, unusual bruising or bleeding, very high ferritin on labs (the 2026 ACR guidelines list IL-1 or IL-6 inhibitors with steroids for sJIA with MAS, which is an off-label use of anakinra, and emapalumab is FDA-approved when MAS does not respond to steroids or keeps coming back)
Severe widespread injection site reaction or allergic reaction (difficulty breathing, facial swelling)
Signs of serious infection: high fever that is different from the sJIA pattern, productive cough, or looking very unwell
Significant neutrophil drop on initial lab check

Questions to take to your next visit

How quickly should we expect the fevers to stop?
What techniques can help with the daily injections? My child is afraid of needles.
Can we give the injection at bedtime to reduce injection site bother?
If anakinra works, would switching to canakinumab (monthly injections) be an option later?
How should I handle the injection site reactions?
If my child is very ill, can we use a higher loading dose?

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Every stage of Anakinra treatment at a glance

Starting anakinra Start to 1 mo

Early response and stabilization 1 mo to 3 mo

Your child has been on daily anakinra for 1-3 months. If the drug is working, the systemic features (fevers, rash) should have resolved quickly and the joints should be improving. The injection site reactions have likely improved by now. Your child's rheumatologist is monitoring inflammatory markers and blood counts regularly. Steroid tapering should be well underway. One practical consideration: many families who start on anakinra because of its rapid onset later discuss switching to canakinumab (monthly injections) for convenience once the disease is controlled. This is a common and reasonable strategy.

For children responding well, anakinra usually continues while the steroid taper is completed. If the daily injection burden is difficult, discuss switching to canakinumab (Ilaris), which is given monthly. Both block the IL-1 pathway, and many children who respond to anakinra also respond to canakinumab. For children with partial response (fevers controlled but persistent arthritis): adding methotrexate is common. For children not responding: switching to IL-6 blockade (tocilizumab) is the next step. For children who responded initially but are now flaring: assess for MAS (can occur despite IL-1 blockade), check adherence (daily injections are hard to maintain perfectly), and consider dose adjustment.

Treatment optimization 3 mo to 6 mo

By 3-6 months, your child's treatment plan should be well-optimized. Either anakinra is controlling the disease effectively and you are maintaining the daily injection routine, or you and the rheumatologist have decided to switch to a different treatment (often canakinumab for convenience or tocilizumab if IL-1 blockade alone is insufficient). If your child is still on anakinra and doing well, the rheumatologist is assessing whether inactive disease has been achieved. Steroids should ideally be stopped or nearly stopped by now.

For children on anakinra who have achieved inactive disease: the major decision is whether to continue anakinra long-term (daily injections) or switch to canakinumab (monthly). Some families and rheumatologists consider this switch for quality of life, especially in younger children for whom daily injections are burdensome. For children in inactive disease on any IL-1 blocker: the goal is sustained remission before any taper. The 2026 ACR guidelines did not agree on how long that should last. For children with ongoing active disease: treatment escalation or switch is needed.

Maintenance therapy 6 mo to 2 yr

Your child is in the maintenance phase on anakinra (or may have switched to canakinumab by now). The treatment goals are the same regardless of which IL-1 inhibitor is being used: maintain inactive disease, support normal growth and development, keep up with non-live vaccinations, and monitor for complications. If your child is still on daily anakinra and the family is coping well with the injections, the rheumatologist may keep that plan. If the daily burden is becoming problematic, the switch to monthly canakinumab remains an option at any time.

Once inactive disease has lasted a while, your rheumatologist may discuss tapering. The 2026 ACR guidelines favor a slow taper over stopping at once and name no exact schedule. Some rheumatologists prefer to switch to canakinumab first and then taper the monthly injections, as it is easier to track. If a flare happens, the 2026 ACR guidelines suggest going back to the plan that last worked.

Long-term outlook 2 yr on

Your child has been managed with IL-1 blockade (anakinra and/or canakinumab) for 2 years or more. By this point, many children have either successfully tapered off biologics and remain in remission, or have established a stable long-term treatment routine. The focus is on comprehensive care: disease monitoring, growth, psychosocial wellbeing, education, and planning for transition to adult care when the time comes.

The long-term prognosis for sJIA has improved dramatically. Children who achieve sustained remission on IL-1 blockade have a much better outlook than in previous generations. Transition planning to adult rheumatology should begin in early adolescence. Long-term surveillance for sJIA complications continues. If your child is off all medications and in sustained remission, periodic check-ins with the rheumatologist (at least annually) are still recommended.

This timeline shows typical patterns from the prescribing information, guidelines and published studies. Your own treatment may differ, and your rheumatology team is the source of truth for your plan. Last checked against the FDA label on November 8, 2026.

Sources

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.

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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?

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?

▸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. ^[1]^[2]

▸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. ^[2]

▸How is Kineret given for systemic JIA?

Kineret (anakinra) is given as a daily subcutaneous injection at about the same time each day, and it can be self-administered at home after training. The standard dose for rheumatoid arthritis is 100mg daily, while off-label dosing for systemic JIA is typically weight-based at 1 to 2mg/kg per day. ^[1]

▸What are the side effects of anakinra?

The most common side effect of anakinra (Kineret) is injection site reactions such as redness, pain, itching, and bruising, which affect most patients at first but usually resolve after 1 to 2 weeks of daily injections. Headaches, nausea, mild upper respiratory infections, and low white blood cell counts can occur, and serious infections are possible, so treatment should not start during an active infection and doctors check for tuberculosis first. Serious allergic reactions and severe skin reactions such as DRESS have been reported, live vaccines should be avoided, and injection sites should be rotated. ^[1]

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