Anakinra — Complete Research Guide (2026)

Last updated 2026-06-30

What is Anakinra?

Anakinra is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra), marketed as Kineret. It is FDA- and EMA-approved for rheumatoid arthritis (in adults with inadequate response to DMARDs) and for cryopyrin-associated periodic syndromes (CAPS), including neonatal-onset multisystem inflammatory disease (NOMID); it also carries approval for deficiency of IL-1 receptor antagonist (DIRA).

The evidence base is human and includes placebo-controlled RCTs in rheumatoid arthritis and prospective studies in NOMID/CAPS.

How does Anakinra work?

Anakinra competitively blocks the interleukin-1 type I receptor, preventing IL-1alpha and IL-1beta from signaling.

This dampens a central driver of inflammation, which is especially pronounced in IL-1-mediated autoinflammatory diseases like CAPS/NOMID.

What does the research say about Anakinra?

• In placebo-controlled trials, anakinra improved rheumatoid arthritis signs and symptoms (for example ACR20 response) versus placebo. ^[1]
• Added to methotrexate, anakinra produced greater ACR responses than methotrexate plus placebo over 24 weeks in rheumatoid arthritis. ^[2]
• In neonatal-onset multisystem inflammatory disease (NOMID/CAPS), IL-1 blockade with anakinra produced rapid, sustained control of rash, fever, and inflammatory markers. ^[3]

Clinical research & studies

The references below are the primary sources cited throughout this guide. Each links directly to PubMed or the regulator. Where evidence is preclinical (animal or in-vitro), that is stated rather than implied.

• [1] Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist — Bresnihan B et al., Arthritis and Rheumatism 1998. (Randomized placebo-controlled trial)
• [2] Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial — Cohen S et al., Arthritis and Rheumatism 2002. (Randomized placebo-controlled trial)
• [3] Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition — Goldbach-Mansky R et al., The New England Journal of Medicine 2006. (Prospective interventional study)
• [4] Safety of extended treatment with anakinra in patients with rheumatoid arthritis — Fleischmann RM et al., Annals of the Rheumatic Diseases 2006. (Long-term safety analysis of randomized data)
• [5] Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate — Genovese MC et al., Arthritis and Rheumatism 2004. (Randomized controlled trial)

Dosing context

Anakinra is a prescription subcutaneous injection, dosed once daily in rheumatoid arthritis and typically weight-based with escalation in NOMID/CAPS, and it requires dose adjustment in significant renal impairment.

This page is educational only and provides no regimen; dosing, infection screening, and neutrophil monitoring must be handled by a qualified clinician.

Side effects & safety profile

The most common adverse effect is injection-site reactions, which are frequent especially in the first month of daily injections.

Anakinra increases the risk of serious infections and can cause neutropenia (low neutrophil counts), so it should not be started during active infection and generally should not be combined with TNF inhibitors, since the anakinra-plus-etanercept combination raised serious-infection risk without added benefit.

Blood-count monitoring and caution in patients with recurrent infection or immunosuppression are important; treatment decisions belong to a specialist.

Stacking & combinations

Anakinra should not be combined with TNF inhibitors such as etanercept, because a controlled trial showed the combination increased serious infections without improving efficacy.

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Frequently asked questions

References

1. [1] Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist — Bresnihan B et al., Arthritis and Rheumatism 1998. PMID: 9870876. View sourceStudy: Randomized placebo-controlled trialAnakinra improved rheumatoid arthritis signs and symptoms and slowed radiographic progression versus placebo.
2. [2] Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomized, double-blind, placebo-controlled trial — Cohen S et al., Arthritis and Rheumatism 2002. PMID: 11920396. View sourceStudy: Randomized placebo-controlled trialAnakinra added to methotrexate gave greater ACR responses than methotrexate alone.
3. [3] Neonatal-onset multisystem inflammatory disease responsive to interleukin-1beta inhibition — Goldbach-Mansky R et al., The New England Journal of Medicine 2006. PMID: 16899778. View sourceStudy: Prospective interventional studyIL-1 blockade with anakinra rapidly and durably controlled NOMID/CAPS disease activity.
4. [4] Safety of extended treatment with anakinra in patients with rheumatoid arthritis — Fleischmann RM et al., Annals of the Rheumatic Diseases 2006. PMID: 16396977. View sourceStudy: Long-term safety analysis of randomized dataExtended anakinra use was tolerable but associated with injection-site reactions and serious-infection risk.
5. [5] Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate — Genovese MC et al., Arthritis and Rheumatism 2004. PMID: 15146410. View sourceStudy: Randomized controlled trialCombining anakinra with etanercept increased serious infections without added efficacy benefit.