Table 2

Characteristics at randomization of the patients who met the objectives of [HCQ] ≥1000 ng/ml and of those with [HCQ]<1000 ng/ml from month 1 to month 7

CharacteristicHigh-[HCQ] group (n=39)Low-[HCQ] group (n=57)p Value
HCQ dose 400 mg/day, n (%)*36 (92)38 (67)0.003
Disease duration (years), median (range)6 (0.5–26.6)7.9 (0.5–30.9)0.048
Duration of HCQ use (years), median (range)4.8 (0.7–20.5)7.8 (0.7–30)0.06
 [HCQ] at randomisation (ng/ml), mean±SD659±288582±2830.20
Adherence reported by physician, median (range)9.4 (3.1–10.0)9.8 (5.6–10)0.07
SLE flares, n/N (%)8/39 (20.5)20/57 (35.1)0.12
SLE flares after exclusion of patients with flares at month 1, n/N (%)5/36 (13.9)18/55 (32.7)0.04
  • All other variables were similar between the two groups at randomisation.

  • *The others received 200 mg/day.

  • HCQ, hydroxychloroquine; [HCQ], blood HCQ concentration; SLE, systemic lupus erythematosus.

  • High-[HCQ] group, patients in whom all [HCQ] values after randomisation were equal to or higher than 1000 ng/ml. Low-[HCQ] group, patients in whom all [HCQ] values were below 1000 ng/ml after randomisation.