Table 1

Baseline demographic and disease characteristics (safety set)*

CharacteristicsPatients
(n=60)
Median age, years (Q1, Q3)18.0 (14.0 to 29.5)
Female, n (%)28 (46.7)
Caucasian, n (%)49 (81.7)
Median duration of disease, years (Q1, Q3)13.8 (9.3 to 24.2)
Median number of flares per year (Q1, Q3)17.5 (12.0 to 27.5)
Active disease at maximum colchicine dose, n (%)59 (98.3)
CRP (mg/L), median (Q1, Q3)102 (56.7 to 202.6)
SAA (mg/L), median (Q1, Q3)618 (265.5 to 1266.0)
PGA score (disease activity), n (%)
 0 (None)0
 1 (Minimal)0
 2 (Mild)9 (15.0)
 3 (Moderate)34 (56.7)
 4 (Severe)17 (28.3)
Arthralgia/arthritis, n (%)
 None21 (35.0)
 Minimal8 (13.3)
 Mild12 (20.0)
 Moderate16 (26.7)
 Severe3 (5.0)
MEFV genotype, n (%)
M694V/M694V 42 (70.0)
M694V/M694I 3 (5.0)
 Other genotypes with mutations in exon 1013 (21.7)
 No mutations in exon 10 2 (3.3)
Prior use of biologics, n (%)16 (26.7)
 Anakinra15 (25.0)
  • *Baseline characteristics at study entry (day 0) for crFMF patients of the safety set of Epoch 4 (from week 41 to week 113). As described in the methods, active disease was an eligibility criterion to enter the study.

  • †Two Japanese patients with no mutations in exon 10 were included in the CLUSTER trial, but not randomised in Epoch 2 and treated with open-label canakinumab. These patients were included in all analyses of the safety population in Epoch 4.

  • crFMF, colchicine-resistant familial Mediterranean fever; CRP, C-reactive protein; n, number of patients; PGA, physician global assessment; SAA, serum amyloid A.