Table 1

Baseline characteristics and disease activity*

Placebo
(n=90)
Baricitinib 2 mg (n=92)Baricitinib 4 mg (n=92)
Age, years, mean (SD)45.5 (12.6)43.4 (11.0)46.2 (12.0)
Female, n (%)85 (94.4)83 (90.2)88 (95.7)
Time since onset of SLE, years, mean (SD)10.2 (8.0)11.8 (9.4)12.1 (10.4)
SLEDAI-2K score, mean (SD)8.9 (2.9)8.6 (3.2)8.8 (3.1)
SLEDAI-2K≥10, n (%)39 (43.3)28 (30.4)37 (40.2)
SLEDAI-2K organ system involvement, n (%)
 Musculoskeletal79 (87.8)82 (89.1)87 (94.6)
 Mucocutaneous79 (87.8)73 (79.3)81 (88.0)
 Immunological53 (58.9)53 (57.6)57 (62.0)
 Haematological12 (13.3)7 (7.6)3 (3.3)
 Renal8 (8.9)8 (8.7)4 (4.3)
 Vascular1 (1.1)3 (3.3)3 (3.3)
 CNS2 (2.2)02 (2.2)
 Cardiovascular and respiratory2 (2.2)1 (1.1)1 (1.1)
 Constitutional1 (1.1)2 (2.2)0
 ≥1A or ≥2B BILAG scores, n (%)52 (57.8)49 (53.3)62 (67.4)
 Physician’s Global Assessment, mean (SD)48.7 (16.9)48.7 (16.1)51.9 (16.1)
 CLASI activity score, mean (SD)5.2 (5.9)4.0 (5.7)3.9 (3.4)
 Tender joint count, mean (SD)7.7 (5.9)8.6 (6.5)8.6 (5.9)
 Swollen joint count, mean (SD)5.4 (4.7)5.2 (4.6)5.8 (4.2)
Urine protein:creatinine ratio, n (%)
 ≤50 mg/mmol85 (94.4)89 (96.7)86 (93.5)
 ˃50 mg/mmol5 (5.6)3 (3.3)6 (6.5)
 eGFR (MDRD), mL/min/1.73 m2, mean (SD)92.5 (22.8)96.0 (21.7)91.1 (24.2)
 SLICC/ACR Damage Index score, mean (SD)0.6 (1.0)0.4 (0.6)0.4 (0.9)
Haematological, mean (SD)
 Haemoglobin, mmol/L-Fe8.0 (0.9)8.1 (0.9)7.9 (0.9)
 Platelets, 109/L239.7 (65.5)250.0 (77.4)245.6 (72.7)
 Leucocytes, 109/L5.5 (2.1)6.2 (2.6)5.9 (2.4)
 Neutrophils, 109/L3.7 (1.7)4.3 (2.2)4.0 (2.1)
 Lymphocytes, 109/L1.3 (0.6)1.4 (0.7)1.4 (0.7)
 Monocytes, 109/L0.3 (0.1)0.3 (0.1)0.3 (0.1)
Immunologic
 ANA titre ≥1:80, n (%)89 (98.9)91 (98.9)87 (94.6)
 Anti-dsDNA, IU/mL, mean (SD)83.9 (133.6)115.5 (190.3)140.1 (300.1)
 Anti-dsDNA ≥30 IU/mL, n (%)42 (46.7)47 (51.1)46 (50.0)
 C3, g/L, mean (SD)1.1 (0.3)1.1 (0.3)1.1 (0.3)
 C3 <90 mg/dL, n (%)24 (26.7)24 (26.1)28 (30.4)
 C4, g/L, mean (SD)0.2 (0.1)0.2 (0.1)0.2 (0.1)
 C4 <10 mg/dL, n (%)11 (12.2)22 (23.9)13 (14.1)
 Anti-Sm ≥30 AU/mL, n (%)9 (10.8)5 (6.0)6 (7.2)
 Anti-RNP ≥30 AU/mL, n (%)24 (28.9)18 (21.4)24 (28.9)
 Anti-SSA/Ro 52≥30 AU/mL, n (%)28 (33.7)22 (26.2)24 (28.9)
 Anti-SSA/Ro 60≥30 AU/mL, n (%)45 (54.2)36 (42.9)34 (41.0)
 Anti-SSB/LA≥30 AU/mL, n (%)13 (15.7)12 (14.3)13 (15.7)
 Antiphospholipid positive, n (%)16 (19.0)23 (27.1)19 (23.2)
 Anticardiolipin IgG ˃14 GPL, n (%)6 (7.1)6 (7.1)4 (4.9)
 Anticardiolipin IgM ˃12 MPL, n (%)13 (15.5)20 (23.5)18 (22.0)
 Serum IgG, g/L, mean (SD)14.1 (6.3)13.9 (3.7)13.6 (4.9)
 Serum IgM, g/L, mean (SD)1.1 (1.7)1.0 (0.6)1.0 (0.7)
Concomitant medications
 Corticosteroids, n (%)66 (73.3)70 (76.1)66 (71.7)
 Prednisone dose (or equivalent; of those taking corticosteroids), mg/day, mean (SD)7.9 (4.6)8.4 (5.7)8.5 (4.4)
 Prednisone dose (or equivalent; of those taking corticosteroids), ≥7.5 mg/day, n (%)31 (47.0)33 (47.1)35 (53.0)
 Antimalarials, n (%)65 (72.2)61 (66.3)67 (72.8)
Immunosuppressants, n (%)39 (43.3)41 (44.6)43 (46.7)
 MTX11 (12.2)15 (16.3)13 (14.1)
 AZA13 (14.4)8 (8.7)9 (9.8)
 MMF10 (11.1)8 (8.7)14 (15.2)
 NSAID, n (%)24 (26.7)25 (27.2)27 (29.3)
  • *For patients included in the gene expression analyses.

  • ACR, American College of Rheumatology; AZA, azathioprine; BILAG, British Isles Lupus Assessment Group; C, complement; CLASI, Cutaneous Lupus Erythematosus Disease Area and Severity Index; CNS, central nervous system; dsDNA, double-stranded DNA; eGFR, estimated glomerular filtration rate; Ig, immunoglobulin; MDRD, Modification of Diet in Renal Disease Study equation; MMF, mycophenolate mofetil; mmol/L-Fe, mmol/L (Fe); MTX, methotrexate; n, number of patients in the specified category; N, number of patients in analysis population; NSAID, nonsteroidal anti-inflammatory drug; RNP, ribonucleoprotein; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index-2000; SLICC, Systemic Lupus International Collaborating Clinics.