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
| Characteristic | High-[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±SD | 659±288 | 582±283 | 0.20 |
| 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.