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FMF - treatment recommendations

IL-1 Inhibitors in Familial Mediterranean Fever (FMF)

The updated EULAR and PReS-endorsed recommendations for the management of Familial Mediterranean Fever (FMF) propose a therapeutic algorithm where IL-1 inhibitors such as Kineret (anakinra) are the preferred additional therapies in patients with an inadequate response to colchicine.1

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IL-1 inhibition

A critical aspect of IL-1 inhibitors is their ability to control subclinical inflammation in patients with colchicine-resistant FMF. This is essential for preventing severe complications such as AA amyloidosis, a potentially life-threatening condition characterized by deposition of inflammatory proteins in various organs.1

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Colchicine Resistance

Although colchicine remains the first-line treatment for FMF, a subset of patients fails to achieve adequate response despite maximum tolerated doses. In these patients, IL-1 inhibitors may be used as an addition to colchicine to enhance disease control when standard therapy is insufficient.1

Colchicine resistance is defined by recurrent clinical attacks (average ≥1 attacks per month over a 3-month period) or persistently elevated serum CRP or SAA in between attacks in the absence of any other plausible explanation.1

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Quality of Life

Biologic treatments such as IL-1 inhibitors can improve health-related quality of life by managing FMF symptoms and reducing attack frequency. This might facilitate resumption of normal daily activities and improved social functioning1

Monitoring

To ensure optimal therapeutic outcomes, the importance of regular monitoring of response, toxicity, and adherence is emphasized. Patients receiving IL-1 inhibitors should be closely followed to:

  • Evaluate treatment efficacy
  • Detect potential adverse effects early
  • Ensure proper medication administration
  • Adjust dosing regimens when necessary
  • Consider dose reduction or discontinuation in cases of sustained remission

Through structured follow-up, treatment can be optimized for each individual patient, maximizing benefits while minimizing risks.1

A valuable asset for the treatment of FMF

Kineret, approved in Europe for the treatment of FMF in 2020, remains an established treatment option for patients with colchicine-resistant FMF due to the high level of evidence supporting its efficacy and safety.2

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Frequently asked questions

How is Kineret administered?
  • Kineret is given in a pre-filled syringe containing 100 mg of anakinra per 0.67 ml (150 mg/ml).1
  • Kineret is given once daily as a subcutaneous injection.1
  • Dosage depends on indication. In children, the dose is determined depending on body weight. Please refer to current SmPC.
How should Kineret be stored?
  • Kineret should be stored in a refrigerator between 2°C and 8°C.1
  • Kineret should not be frozen or shaken.1
  • Kineret should be kept in its original carton and away from light.1

 

 

Abbreviations
IL-1, Interleukin 1; FMF, Familial Mediterranean Fever; CRP, C-reactive protein; SAA, serum amyloid A

 

References
  1. Ozen S, Sağ E, Oton T, et al. EULAR/PReS endorsed recommendations for the management of familial Mediterranean fever (FMF): 2024 update. Ann Rheum Dis. 2025 Apr 9:S0003-4967(25)00084-6.
  2. Kineret (anakinra). Summary of product characteristics.

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