Can anakinra be continued during an acute infection?

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Last updated: October 21, 2026 • View editorial policy

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Anakinra Should Be Discontinued During Acute Infections in Rheumatoid Arthritis, But Risk-Benefit Must Be Carefully Weighed in Life-Threatening Autoinflammatory Conditions

In rheumatoid arthritis patients, anakinra should be discontinued if a serious infection develops, and should not be initiated in patients with active infections. 1 However, for patients with severe autoinflammatory diseases like NOMID or DIRA, the risk of disease flare when discontinuing anakinra must be weighed against the potential risk of continued treatment during infection. 1

Clinical Decision Algorithm

For Rheumatoid Arthritis Patients:

  • Stop anakinra immediately if serious infection develops 1
  • Do not restart until infection has completely resolved
  • The FDA label is explicit: "Do not initiate KINERET in patients with active infections" 1
  • This recommendation is based on the 2-3% incidence of serious infections (primarily bacterial: cellulitis, pneumonia, bone/joint infections) observed in clinical trials 1

For Life-Threatening Autoinflammatory Conditions (NOMID, DIRA, Still's Disease):

The decision is more nuanced:

Continue anakinra during infection when:

  • The underlying autoinflammatory disease poses immediate life-threatening risk (e.g., severe pericarditis, impending MAS)
  • Stopping anakinra would likely trigger catastrophic disease flare
  • The infection can be adequately treated with antimicrobials while maintaining immunosuppression

Supporting evidence for continuation:

  • Anakinra has been safely used in critically ill septic patients in intensive care units with no safety concerns 2
  • IL-1 and IL-6 inhibitors were proven safe in severe COVID-19 patients 2
  • Real-world data shows anakinra can be effective and safe even during concurrent infections 3, 4

Key Safety Considerations

Infection Risk Profile:

  • Serious infection rate: 2-3% in RA patients over 6 months 1
  • Most common infections: Bacterial pneumonia, cellulitis, bone/joint infections 1
  • Opportunistic infections: Rare but reported (fungal, mycobacterial, bacterial) 1
  • Among IL-1 inhibitors, anakinra has the most reassuring safety profile compared to other biologics 2

Special Populations at Higher Risk:

  • Asthma patients: 4.5% serious infection rate vs 0% in placebo 1
  • Elderly patients: Higher baseline infection risk; use caution 1
  • Renal impairment: Drug substantially excreted by kidney; consider dose adjustment 1

Monitoring During and After Infection

If continuing anakinra through infection:

  • Monitor CBC and liver function tests closely (more frequently than the standard every 3-4 months) 5
  • Watch for neutropenia (occurs in 0.4% of patients) 1
  • Ensure aggressive antimicrobial therapy
  • Daily clinical assessment for infection progression

After infection resolution:

  • Can safely resume anakinra in RA patients once infection completely cleared
  • No specific washout period required given short 4-6 hour half-life 1

Critical Pitfalls to Avoid

  1. Don't confuse RA with autoinflammatory syndromes: The risk-benefit calculation differs dramatically. RA patients have alternative treatment options; NOMID/DIRA patients may not.

  2. Don't overlook concurrent immunosuppression: The infection risk increases substantially when anakinra is combined with TNF inhibitors (7% serious infection rate) 1. This combination is explicitly not recommended 1.

  3. Don't miss neutropenia: 8% of patients develop decreased WBC counts 1. Check CBC before deciding to continue through infection.

  4. Don't underestimate respiratory infections: The respiratory tract is the most common site of serious infection with anakinra 1, 6.

Bottom Line for Clinical Practice

The FDA label provides clear guidance: stop anakinra for serious infections in RA. 1 However, the 2024 EULAR/PRES guidelines acknowledge that for severe autoinflammatory diseases, the calculus changes—the risk of stopping may exceed the risk of continuing, particularly given anakinra's demonstrated safety even in septic ICU patients. 2

When in doubt, err on the side of stopping anakinra for infections in RA patients, but involve rheumatology consultation immediately for autoinflammatory disease patients before discontinuing, as disease flares can be catastrophic.

References

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.