Table 1.
Baseline characteristics of patients from the two trials and two treatment groups
| Characteristics | Proof-of-concept trial (n=70) | Met Lupus trial (n=131) |
Pooled data (n=201) |
Metformin (n=99) |
Placebo/nil (n=102) |
| Age (years) | 31.00±12.73 | 33.23±11.65 | 32.47±12.05 | 32.63±12.07 | 32.31±12.08 |
| Female | 87.1% (61) | 93.1% (122) | 91.0% (183) | 89.9% (89) | 92.2% (94) |
| BMI (kg/m2) | 22.22±3.52 | 22.84±3.64 | 22.62±3.60 | 22.29±3.44 | 22.95±3.74 |
| Disease duration (years) | 3.46±3.78 | 4.74±4.28 | 4.30±4.13 | 4.01±3.74 | 4.57±4.51 |
| SELENA-SLEDAI | 1.63±1.65 | 2.44±1.54 | 2.15±1.62 | 2.04±1.60 | 2.26±1.65 |
| Serological results | |||||
| dsDNA+ | 58.6% (41) | 61.1% (80) | 60.2% (121) | 59.6% (59) | 60.8% (62) |
| Low C3 | 55.7% (39) | 51.9% (68) | 53.2% (107) | 51.5% (51) | 54.9% (56) |
| Low C4 | 24.3% (17) | 16.0% (21) | 18.9% (38) | 18.2% (18) | 19.6% (20) |
| Baseline therapy | |||||
| Prednisone (mg/day) | 9.6±4.46 | 10.53±4.44 | 10.21±4.46 | 10.09±4.63 | 10.32±4.31 |
| Hydroxychloroquine | 88.6% (62) | 90.1% (118) | 89.6% (180) | 91.9% (91) | 87.3% (89) |
| IS* | 60.0% (42) | 67.2% (88) | 64.7% (130) | 67.7% (67) | 61.8% (63) |
| Mycophenolate | 24.3% (17) | 34.4% (45) | 30.9% (62) | 29.3% (29) | 32.4% (33) |
| Methotrexate | 21.4% (15) | 18.3% (24) | 19.4% (39) | 20.2% (20) | 18.6% (19) |
| Azathioprine | 11.4% (8) | 6.9% (9) | 8.5% (17) | 9.09% (9) | 7.8% (8) |
| Ciclosporin | 1.4% (1) | 2.3% (3) | 2.0% (4) | 2.0% (2) | 2.0% (2) |
| Tacrolimus | 0% (0) | 3.1% (4) | 2.0% (4) | 4.0% (4) | 0% (0) |
| Leflunomide | 1.4% (1) | 2.3% (3) | 2.0% (4) | 3.03% (3) | 1.0% (1) |
| Flares | |||||
| Any | 30% (21) | 27.5% (36) | 28.4% (57) | 21.2% (21) | 35.3% (36) |
| Major | 12.9% (9) | 20.6% (27) | 17.9% (36) | 12.1% (12) | 23.5% (24) |
*IS: immunosuppressive agents; none of the patients were treated with sirolimus. Number of patients are indicated in parentheses.
BMI, body mass index.