To evaluate the efficacy on clinical symptoms in case of FMF attack among FMF patients resistant to Colchicine of
* on demand anakinra treatment (100 mg/d from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) associated with daily colchicine. * compared to analgesic associated with daily colchicine in patients refusing continuous anti-IL-1 treatment.
Age >= 6 years old with no upper limit
Proven FMF according to Livneh international criteria and 2 non ambiguous MEFV mutations.
Colchicine resistance defined as persistent FMF attack despite the maximum daily posology of colchicine (average one or more attacks per month over a 3-months period)
Arthritis or
Evidence of active tuberculosis
Infection requiring treatment with intravenous antibiotics within 2 weeks prior to inclusion
History of recurrent infection (Need more than 4 courses of antibiotic treatment per year (in children) or more >2 times per year (in adults), experience pneumonia twice over any time or >3 bacterial sinusitis in 1 year)
Contraindication to anakinra (Hypersensitivity to the active substance or to any of the excipients (Citric acid, anhydrous Sodium chloride, Disodium edetate dehydrate, Polysorbate 80, Sodium hydroxide, Water for injections ) or to E. coli derived proteins
Parallel
ANAKINRA
DrugOn demand Anakinra 100 mg/j from the prodromal phase of the attack until 24 hours of remission (during 7 days maximum) + colchicine + on demand analgesics
Mean number of FMF-attacks per month at 6 months of treatment.
* FMF attacks is defined by a painful (consensual definition) manifestation during 12 to 72 hours, in either : * abdomen (with features consistent with a diagnosis of peritonitis), * chest (with features consistent with a diagnosis of pleuritis), * joints (with features consistent with a diagnosis of lower extremity large joint monoarthritis), * skin (with features consistent with a diagnosis of erysipeloid rash) * The painful manifestation can be (or not) accompanied by fever of ≥ 38°C Patients will be asked to note the number of days of pain of each inflammatory attack on a diary.
Cumulative days of FMF attack treatment from randomization to 6 months
The number of days of injections (for anakinra arm) or number of days of consumption of analgesics (for control group) will be collected via a notebook . Safety
AIDAI (Auto-inflammatory Diseases activity index) score
Patients will complete the AIDAI (Auto-inflammatory Diseases activity index) score monthly.
Number of painful days and severity of FMF attacks occurring between randomization and M6
Number of painful days will be measured by VAS (Visual Analogue Scale) and collected via a notebook).
Quality of life score measured by EuroQOL questionnaire (EQ-5D5L)
The EQ5D5L will be completed at each visit
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