Table 1.
Baseline characteristics (mITT)
| Baminercept N=33 |
Placebo N=19 |
|
|---|---|---|
| Age (years) mean (SD) | 50 (10.9) | 55 (11.0) |
| Gender (N, % female) | 31 (94) | 18 (95) |
| Race N (%) | ||
| White | 28 (85) | 16 (84) |
| Black | 3 (9) | 3 (16) |
| Other | 2 (6) | 0 (0) |
| Physician global disease activity (0–100 mm), mean (SD) | 48.6 (20.6) | 50.3 (20.5) |
| Subject global disease activity (0–100 mm), mean (SD) | 70.3 (16.5) | 73.5 (16.4) |
| Subject assessment of symptoms (0–100 mm), mean (SD) | ||
| Overall dryness | 71.3 (17.7) | 71.4 (16.9) |
| Fatigue | 70.0 (17.5) | 67.0 (18.5) |
| Joint pain | 46.5 (24.9) | 55.1 (25.1) |
| Unstimulated whole salivary flow (mL/min), mean (SD) | 0.11 (0.21) | 0.09 (0.11) |
| Stimulated whole salivary flow (mL/min), mean (SD) | 0.44 (0.49) | 0.49 (0.30) |
| Schirmer-I test (mm), mean (SD) | ||
| Left eye | 10.2 (11.4) | 10.5 (12.8) |
| Right eye | 9.8 (10.7) | 14.6 (14.7) |
| Total ocular staining score (0–36),* mean (SD) | 19.2 (11.9) | 15.1 (11.5) |
| ESSDAI score (0–123), mean (SD) | 2.7 (2.8) | 3.8 (4.2) |
| SF-36 (0–100), mean (SD) | ||
| Physical aggregate score | 39.2 (8.1) | 39.8 (10.8) |
| Mental aggregate score | 46.1 (10.9) | 45.0 (11.2) |
| Anti-SS-A (Ro) or anti-SS-B (La) positive, N (%) | 29 (88) | 15 (79) |
| Positive lip biopsy, N (%) | 9 (27) | 7 (37) |
| IgG (mg/dL), mean (SD) | 1431 (530) | 1196 (475) |
| Concomitant therapy, N (%) | ||
| Hydroxychloroquine | 19 (58) | 10 (53) |
| Prednisone ≤ 10 mg/d | 0 (0) | 1 (5) |
| Cholinergic stimulants | 12 (36) | 8 (42) |
*
Combined ocular staining score for both eyes.
ESSDAI = EULAR Sjögren’s syndrome disease activity index; SF-36 = 36-Item Short Form Health Survey