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DI-069 Cutaneous tolerance to long term anakinra therapy: report of a 9 year experience and review of french pharmacovigilance
  1. M Bonsergent1,
  2. J Giraud1,
  3. R Asgari2,
  4. L Deschamps3,
  5. S Ottaviani4,
  6. C Bejar5,
  7. T Papo6,
  8. JF Alexandra6,
  9. C Tesmoingt1
  1. 1Hôpital Bichat-Claude Bernard, Pharmacy, Paris, France
  2. 2Hôpital Européen Georges-Pompidou, Regional Centre of Pharmacovigilance, Paris, France
  3. 3Hôpital Bichat-Claude Bernard, Department of Pathology, Paris, France
  4. 4Hôpital Bichat-Claude Bernard, Department of Rheumatology, Paris, France
  5. 5Hôpital Bichat-Claude Bernard, Department of Dermatology, Paris, France
  6. 6Hôpital Bichat-Claude Bernard, Department of Internal Medicine, Paris, France


Background Anakinra, a recombinant human interleukin-1 receptor antagonist, is commonly used in the treatment of rheumatoid arthritis and has also shown efficacy in some autoinflammatory diseases. This drug is generally known for being well tolerated.

Purpose The aim of the study was to explore cutaneous tolerance in patients who received long term anakinra treatment in our hospital and investigate similar cases of adverse cutaneous reactions reported in the French pharmacovigilance database.

Material and methods A retrospective study between January 2007 and April 2016 was conducted, using the hospital’s medical software and medical team collaboration. Patients with short course treatment (ie, mostly gout) were excluded. Data were collected through medical files and focused on: age, sex, anakinra indication, dose, cutaneous side effect, Naranjo score, latency time, evolution, withdrawal and reintroduction, and biopsy of skin lesions if performed. In a second investigation, French pharmacovigilance database requests with the terms ‘anakinra’ and ‘skin and subcutaneous tissue disorders’ was performed from 2003 (the date of anakinra approval in France) to April 2016.

Results We identified 13 patients treated with long term anakinra medication in our hospital. 9 patients (69%) developed mild to severe skin adverse reaction. 4 (31%) had to stop treatment without rechallenging. This percentage of withdrawal after this side effect increased to 70% (n=26/37) within the French pharmacovigilance database research. Clinically, skin adverse reactions ranged from a small inflammatory reaction at the injection site to severe erythematous and oedematous eruption, painful and pruriginous with panniculitis on the four limbs. The mean interval of appearance was about 7 days after initiation of anakinra. 2 patients developed an acute onset of erythematous and painful eruption localised at all injection sites at the same time which indicates a ‘recall syndrome’.

Conclusion This study was the first to describe real life tolerance of anakinra over a 9 year period in a wide spectrum of diseases. Our series highlighted an important rate of major side effects (69%) leading to treatment discontinuation. This may be of major concern as anakinra is usually used as rescue treatment for autoinflammatory diseases.

No conflict of interest

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