Full Papers
A single dose of anakinra for arresting familial Mediterranean fever attacks: a proof-of-concept study
E. Giat1, A. Livneh2, I. Ben-Zvi3, A. Druyan4, D. Bar5, D.J. Ozeri6, G. Almoznino7, M. Lidar8
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan; and Gray Faculty of Medical and Health Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel.
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan; Gray Faculty of Medical and Health Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv; and Internal Medicine F, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan; Gray Faculty of Medical and Health Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv; and Internal Medicine F, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
- Gray Faculty of Medical and Health Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel.
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
- Faculty of Oral Medicine, Hebrew University of Jerusalem; Big Biomedical Data Research Laboratory, Dean’s Office, Hadassah Medical Center, Jerusalem; and Department of Oral Medicine, Sedation & Maxillofacial Imaging, Hadassah Medical Center, Faculty of Dental Medicine, Hebrew University of Jerusalem, Israel.
- Rheumatology Unit, Sheba Medical Center, Tel Hashomer, Ramat Gan; and Gray Faculty of Medical and Health Sciences, Tel Aviv University, Ramat Aviv, Tel Aviv, Israel. merav.lidar@gmail.com
CER18235
2025 Vol.43, N°10
PI 1735, PF 1741
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PMID: 41133353 [PubMed]
Received: 15/10/2024
Accepted : 03/03/2025
In Press: 23/10/2025
Published: 23/10/2025
Abstract
OBJECTIVES:
Familial Mediterranean fever (FMF) is characterised by painful inflammatory bouts, typically lasting one to three days. Analgesics, the only available treatment to alleviate acute attacks, are often ineffective in reducing pain and attack duration. This study evaluates the efficacy of a single dose of anakinra, administered at the onset of FMF attack, in arresting the attack.
METHODS:
This prospective self-controlled case series involved patients receiving a single prefilled syringe with 100 mg anakinra for self-administration at attack onset. The primary outcome was the duration of anakinra-treated attacks compared to baseline attack duration. Additional attacks were treated with self-procured anakinra and analysed separately.
RESULTS:
Twenty-three attacks experienced by 23 patients and treated with the furnished anakinra were analysed. Treated attacks were arrested within 5.4±6 hours from anakinra administration, and lasted 8.33±6.8 hours from onset, significantly shorter than the 56.3±16.8 hours reported at baseline (p=0.0001). Use of purchased anakinra (43 injections by 6 patients) attained equal outcome. Early administration of anakinra (within ≤4 hours of attack onset) resulted in attack termination within ≤4 hours from anakinra injection in 17 of 20 (85%) and 37 of 41 (90%) of the attacks treated with furnished and procured anakinra, respectively. Adverse events were limited to one patient experiencing an injection site reaction.
CONCLUSIONS:
Acute FMF attacks are highly responsive to early anakinra administration with low safety cost.
