PW01-005 – Effects of placebo and colchicine on FMF patients

Results A total amount of 50 patients (22 girls, 28 boys) were included. The median age of the patients was 8.5 years (2.5-17.5). 78% of the patients suffered from fever attacks suggestive of FMF every 1-4 weeks. The attack interval of the remaining patients was more than one month. At the time of admission, the median values for ESR and CRP were; 24.5 mm/hr (1-100) and 2 mg/dl (0-31), respectively. Half of the patients (n=25) were randomized to colchicine and the other half (n=25) to placebo. At the unblind period the results were assessed: patients treated with colchicine had lower ESR when compared to placebo in the first phase only (p=0.004). CRP, WBC and SAA levels were not statistically different neither in the first phase nor after the cross-over period. However, the number of attacks were significantly less in the colchicine group (median 0 attack) when compared to the placebo group (median 1 attack) (p=0.011). In the study group, 13 patients were homozygous, 11 patients were compound heterozygous and seven patients were heterozygous for MEFV mutation. The rest of the patients (38%) did not carry any MEFV mutations.