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 (%) | |||
| Musculoskeletal | 79 (87.8) | 82 (89.1) | 87 (94.6) |
| Mucocutaneous | 79 (87.8) | 73 (79.3) | 81 (88.0) |
| Immunological | 53 (58.9) | 53 (57.6) | 57 (62.0) |
| Haematological | 12 (13.3) | 7 (7.6) | 3 (3.3) |
| Renal | 8 (8.9) | 8 (8.7) | 4 (4.3) |
| Vascular | 1 (1.1) | 3 (3.3) | 3 (3.3) |
| CNS | 2 (2.2) | 0 | 2 (2.2) |
| Cardiovascular and respiratory | 2 (2.2) | 1 (1.1) | 1 (1.1) |
| Constitutional | 1 (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/mmol | 85 (94.4) | 89 (96.7) | 86 (93.5) |
| ˃50 mg/mmol | 5 (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-Fe | 8.0 (0.9) | 8.1 (0.9) | 7.9 (0.9) |
| Platelets, 109/L | 239.7 (65.5) | 250.0 (77.4) | 245.6 (72.7) |
| Leucocytes, 109/L | 5.5 (2.1) | 6.2 (2.6) | 5.9 (2.4) |
| Neutrophils, 109/L | 3.7 (1.7) | 4.3 (2.2) | 4.0 (2.1) |
| Lymphocytes, 109/L | 1.3 (0.6) | 1.4 (0.7) | 1.4 (0.7) |
| Monocytes, 109/L | 0.3 (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) |
| MTX | 11 (12.2) | 15 (16.3) | 13 (14.1) |
| AZA | 13 (14.4) | 8 (8.7) | 9 (9.8) |
| MMF | 10 (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.