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Efficacy and safety of long-term treatment with intravenous colchicine for familial Mediterranean fever (FMF) refractory to oral colchicine

  • Chagai Grossman
  • Itzhak Farberov
  • Olga Feld
  • Avi Livneh
  • Ilan Ben-Zvi
Pharmacovigilance
  • 35 Downloads

Abstract

Colchicine is the mainstay of treatment for familial Mediterranean fever (FMF). Intravenous (IV) colchicine, administered over several months, has been shown to be effective for FMF patients unresponsive to oral colchicine. The objective of this study was to evaluate the efficacy and safety of long-term IV colchicine treatment in oral colchicine-resistant FMF. We analyzed data of 15 patients with frequent FMF attacks, despite a maximal tolerated dose of oral colchicine (2–3 mg/day), who were treated with weekly IV injections of 1 mg of colchicine for at least 12 months. Treatment efficacy was determined by changes in frequency, duration and severity of FMF attacks. Safety was assessed according to adverse events. The mean duration of IV colchicine treatment was 5.16 ± 2.85 years. Decreases were observed from pre-treatment period in the monthly mean rates of abdominal attacks (from 5.6 ± 3.7 to 1.9 ± 3.3, p = 0.0009), joint attacks (from 6.5 ± 5.1 to 1.6 ± 1.6, p = 0.01) and overall attacks (from 22.3 ± 16.2 to 7.4 ± 5.7, p = 0.002) as well as in the mean duration (from 3.8 ± 1.5 to 2.4 ± 1.1 days per attack, p = 0.008) and severity of attacks (from 9.9 ± 0.3 to 5.7 ± 2.6, on a scale of 0–10, p < 0.05). The rate of adverse events was low, and they were mainly gastrointestinal. No severe or serious adverse events were recorded. Long-term treatment with IV colchicine in patients unresponsive to oral colchicine therapy is effective and safe.

Keywords

FMF Colchicine Intravenous treatment Adverse events Oral colchicine-resistant FMF 

Notes

Acknowledgements

This study was supported by a grant from the Johanna Feller family in her memory and in the memory of other family members, who were the victims of the Nazi holocaust.

Compliance with ethical standards

Conflict of interest

Chagai Grossman, Itzhak Farberov, Olga Feld, Avi Livneh and Ilan Ben-Zvi declare they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Chagai Grossman
    • 1
    • 2
    • 4
  • Itzhak Farberov
    • 1
  • Olga Feld
    • 1
  • Avi Livneh
    • 1
    • 2
    • 3
    • 4
  • Ilan Ben-Zvi
    • 1
    • 2
    • 3
    • 4
  1. 1.Department of Internal Medicine FThe Chaim Sheba Medical CenterTel-HashomerIsrael
  2. 2.Rheumatology UnitThe Chaim Sheba Medical CenterTel-HashomerIsrael
  3. 3.Heller Institute of Medical ResearchThe Chaim Sheba Medical CenterTel-HashomerIsrael
  4. 4.Sackler Faculty of MedicineTel-Aviv UniversityTel-AvivIsrael

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