Background: The use of colchicines for treating Familial Mediterranean fever (FMF) patients has been shown to be highly effective. However, the drug was only approved by the FDA for children over 4 years of age since no evidence exists regarding the efficacy and safety of colchicine at younger ages. Since we use routinely colchicine at these ages we aimed to assess the safety and efficacy of colchicine in children < 4 years old.
Methods: Data regarding children diagnosed with FMF before the age of 4 years at Schneider rheumatology clinic between 3/10-3/17 were collected and matched with identical MEFV mutated 4-9 years old patients. Efficacy was assessed by improvement of frequency and duration of attacks. Adverse events were assessed according to the Woodworth scale.
Results: Eighty-seven FMF patients were included, 43 under 4 years. The effective dose was found to be similar between both groups: 0.05 mg/kg. Both groups showed a similar decrease in duration of attacks (88.1% among < 4 years, 87.2% among > 4 years; P=0.260) and in their frequency (87.2% among < 4 years, 88.1% among > 4 years; P=0.94) and similar complete clinical remission [18(46.1%) of the patients < 4 years, 21(53.9%) > 4 years; P=0.497]. The most frequent adverse event was diarrhea, with a similar prevalence [10(23.3%)4 years; P=0.75]. There were no other significant differences in other adverse events. Both groups had a similar grade according to the Woodworth scale.
Conclusion: Colchicine is effective and safe in FMF patients under 4 years old.
