Characteristics of the study subjects at randomisation, by group
| Characteristic | Total (n=171) | Group 1 (n=84) | Group 2 (n=87) | p Value |
|---|---|---|---|---|
| Age (years), mean±SD | 40±11 | 41±11 | 38±11 | 0.09 |
| Sex, female, n (%) | 149 (87) | 72 (86) | 77 (89) | 0.60 |
| HCQ dose 400 mg/day, n (%)* | 142 (83) | 65 (77) | 77 (89) | 0.053 |
| Disease duration (years), median (range) | 7.8 (0.5–30.9) | 7.8 (0.5–30.9) | 7.9 (0.5–28.6) | 0.99 |
| Duration of HCQ use (years), median (range) | 7.2 (0.5–30) | 6.2 (0.5–28.2) | 7.8 (0.6–30) | 0.63 |
| Associated APS, n (%) | 28 (16) | 15 (18) | 13 (15) | 0.60 |
| Renal disorder, n (%) | 48 (28) | 22 (26) | 26 (30) | 0.60 |
| Ever used prednisone, n (%) | 137 (80) | 66 (79) | 71 (82) | 0.62 |
| Ever used immunosuppressive drugs, n (%) | 69 (40) | 31 (37) | 38 (44) | 0.40 |
| Creatinine clearance (ml/min), mean±SD | 112±36 | 109±33 | 115±39 | 0.34 |
| PGA, median (range) | 0.24 (0–2.01) | 0.24 (0–1.99) | 0.28 (0–2.01) | 0.095 |
| Active disease (SELENA-SLEDAI>4), n (%) | 23 (13.4) | 9 (10.7) | 14 (16) | 0.30 |
| SELENA-SLEDAI score, median (range) | 2 (0–12) | 1 (0–12) | 2 (0–9) | 0.20 |
| Low levels of complement, n (%) | 17 (9.9) | 7 (8.3) | 10 (11.5) | 0.49 |
| Increased anti-dsDNA, n (%) | 63 (37) | 27 (32) | 36 (41) | 0.21 |
| Current prednisone use, n (%) | 94 (55) | 44 (52) | 50 (57) | 0.50 |
| Prednisone dose (mg/day), mean±SD | 8.0±4 | 7.8±3.6 | 8.6±4.3 | 0.29 |
| Current use of immunosuppressive drugs, n (%) | 32 (19) | 15 (18) | 17 (20) | 0.77 |
| BMI, mean±SD | 25±5 | 25±5 | 25±6 | 0.92 |
| Active smokers, n (%) | 41 (24) | 18 (21) | 23 (26) | 0.44 |
| Adherence to treatment reported by physician, median (range) | 9.5 (3.1–10.0) | 9.5 (3.9–10.0) | 9.5 (3.1–10.0) | 0.90 |
| [HCQ] at randomisation (ng/ml), mean±SD | 659±313 | 691±314 | 628±311 | 0.19 |
| SLE flares, n/N (%) | 45/171 (26.3) | 21/84 (25) | 24/87 (27.6) | 0.70 |
| SLE flares after exclusion of patients with flares at month 1, n/N (%) | 35/160 (21.9) | 17/79 (21.5) | 18/81 (22.2) | 0.93 |
*The others received 200 mg/day.
APS, antiphospholipid syndrome; BMI, body mass index; HCQ, hydroxychloroquine; [HCQ], blood HCQ concentration; SLE, systemic lupus erythematosus; SELENA-SLEDAI, Safety of Estrogens in Lupus Erythematosus National Assessment SLE Disease Activity Index; PGA, physician's global-assessment visual analogue scale.
Group 1, standard treatment; group 2, adjusted HCQ dosing regimen.