Table 1 Baseline demographic variables of the cohort analysed

Age group (years)

 <35

348 (29.0%)

224 (28.3%)

124 (30.2%)

 35–55

664 (55.2%)

436 (55.1%)

228 (55.6%)

 >55

190 (15.8%)

132 (16.7%)

58 (14.2%)

Female

1131 (94.1%)

739 (93.3%)

392 (95.6%)

Disease duration (years)

5.58 (1.92, 12.7)

5.75 (1.92, 12.7)

5.46 (1.83, 11.9)

ACR/SLICC-DI

0 (0, 2)

0 (0, 2)

0 (0, 2)

SLEDAI-2K

10 (8, 12)

10 (8, 12)

10 (8, 12)

nBILAG-2004 score median (IQR)

20 (16, 24)

20 (16, 24)

20 (16, 24)

BILAG-2004 A or B system score

 Constitutional

117 (9.73%)

74 (9.34%)

43 (10.5%)

 Mucocutaneous

990 (82.4%)

653 (82.5%)

337 (82.2%)

 Neuropsychiatric

50 (4.16%)

36 (4.55%)

14 (3.41%)

 Musculoskeletal

1126 (93.7%)

741 (93.6%)

385 (93.9%)

 Cardiorespiratory

132 (11.0%)

89 (11.2%)

43 (10.5%)

 Gastrointestinal

23 (1.91%)

13 (1.64%)

10 (2.44%)

 Ophthalmological

15 (1.25%)

10 (1.26%)

5 (1.22%)

 Renal

91 (7.57%)

62 (7.83%)

29 (7.07%)

 Haematological

12 (1.00%)

9 (1.14%)

3 (0.73%)

Serology

 Anti-Ro

571 (48.2%)

373 (47.8%)

198 (49.0%)

 Anti-RNP

353 (29.8%)

235 (30.1%)

118 (29.2%)

 Anti-dsDNA

334 (28.2%)

211 (27.1%)

123 (30.4%)

 Anti-Smith (Sm)

311 (27.3%)

204 (26.2%)

107 (26.5%)

 Low C3 level

395 (33.4%)

257 (33.0%)

138 (34.2%)

 Low C4 level

482 (40.8%)

320 (41.1%)

162 (40.1%)

Baseline steroid use

1129 (93.9%)

757 (95.6%)

372 (90.7%)

Baseline steroid dose (mg/day)

10 (5, 15)

10 (5, 15)

10 (5, 15)

Concomitant therapy

 Anti-malarial

884 (73.5%)

595 (75.1%)

289 (70.5%)

 Methotrexate

251 (20.9%)

165 (20.8%)

86 (21.0%)

 Leflunomide

37 (3.08%)

37 (3.08%)

37 (3.08%)

 Azathioprine

321 (26.7%)

321 (26.7%)

321 (26.7%)

 Mycophenolate mofetil

143 (11.9%)

88 (11.1%)

55 (13.4%)

Drop out from trial

385 (32.0%)

259 (32.7%)

126 (30.7%)

Withdrawal (lack of efficacy)

174 (14.5%)

115 (14.5%)

59 (14.4%)

Withdrawal (adverse events)

78 (6.49%)

52 (6.57%)

26 (6.34%)