Demographics and clinical baseline characteristics by ISM status of patients in four lupus studies
| Parameter | Phase I rontalizumab trial–mild SLE | EXPLORER trial—moderate-to-severe SLE | ||||
|---|---|---|---|---|---|---|
| ISM-Low (n=32) | ISM-High (n=28) | Total (N=60) | ISM-Low (n=40) | ISM-High (n=95) | Total (N=135) | |
| Age (years), mean (SD) | 48.2 (9.7) | 46.5 (10.5) | 47.4 (10.0) | 42.8 (11.4) | 38.8 (10.9) | 39.9 (11.2) |
| SLE duration (years), mean (SD) | 7.5 (5.6) | 10.4 (7.1) | 8.8 (6.4) | 8.2 (7.9) | 9.2 (8.0) | 8.9 (7.7) |
| Female, % | 97 | 93 | 95 | 100 | 92 | 94 |
| Race/ethnicity, % | ||||||
| Black | 12.5 | 42.9 | 26.7 | 12.5 | 29.5 | 24.4 |
| Hispanic* | 0 | 7.1 | 3.3 | 12.5 | 16.8 | 15.6 |
| White | 87.5 | 50 | 70 | 72.5 | 49.5 | 56.3 |
| Other | 0 | 0 | 0 | 2.5 | 4.2 | 3.7 |
| BILAG index global, mean (SD) | N/A | N/A | N/A | 13.1 (4.7) | 15.2 (5.2) | 14.5 (5.2) |
| SELENA-SLEDAI, mean (SD) | 4.1 (2.6) | 2.9 (2.7) | 3.6 (2.7) | 9.3 (5.2) | 9.2 (8.0) | 10.9 (6.4) |
| PGA, mean (SD) | 25.5 (15.1) | 17.3 (17.6) | 21.7 (16.7) | 50.5 (20.4) | 55.7 (15.3) | 54.1 (17.0) |
| Musculoskeletal involvement, %† | 37.5 | 28.6 | 33.3 | 92.5 | 80.0 | 83.7 |
| Mucocutaneous involvement, %† | 84.4 | 64.3 | 75.0 | 60.0 | 81.1 | 74.8 |
| Proteinuria (>0.5 g), % | 0.0 | 0.0 | 0.0 | 0.0 | 2.1 | 1.5 |
| Serum creatine (mg/dL), mean (SD) | 0.8 (0.1) | 0.9 (0.2) | 0.8 (0.2) | 0.8 (0.2) | 0.7 (0.2) | 0.7 (0.2) |
| Serum C reactive protein (mg/dL), mean (SD) | 0.59 (0.71) | 0.34 (0.35) | 0.47 (0.58) | 0.89 (1.33) | 0.79 (1.44) | 0.81 (1.41) |
| LUNAR Trial‡—LN | Phase II Rontalizumab ROSE Trial—Moderate-to-Severe SLE | |||||
|---|---|---|---|---|---|---|
| ISM-Low (n=21) | ISM-High (n=59) | Total (N=80) | ISM-Low (n=58) | ISM-High (n=180) | Total (N=238) | |
| Age (years), mean (SD) | 31.4 (10.9) | 30.0 (9.1) | 30.4 (9.6) | 42.6 (11.8) | 37.6§ (10.9) | 38.8 (11.3) |
| SLE duration (years), mean (SD) | 6.2 (6.7) | 4.7 (4.6) | 5.1 (5.2) | 7.2 (7.7) | 6.2 (5.8) | 6.5 (6.3) |
| Female, % | 81 | 93 | 90 | 97 | 93 | 94 |
| Race/ethnicity, % | ||||||
| Black | 19.1 | 20.3 | 20 | 8.6 | 16.1 | 14.3 |
| Hispanic* | 57.1 | 40.7 | 45 | 25.9 | 36.1 | 33.6 |
| White | 23.8 | 37.3 | 33.8 | 55.2 | 43.3 | 46.2 |
| Other | 0 | 1.7 | 1.3 | 10.3 | 4.4 | 5.9 |
| BILAG index global, mean (SD) | 15.8 (5.8) | 14.3 (6.5) | 14.7 (6.3) | 11.9 (4.9) | 11.0 (4.6) | 11.2 (4.7) |
| SELENA-SLEDAI, mean (SD) | N/A | N/A | N/A | 9.2 (2.6) | 10.0 (3.5) | 9.8 (3.3) |
| PGA, mean (SD) | 51.6 (24.2) | 49.4 (21.2) | 50.0 (21.9) | 52.1 (17.2) | 57.5 (16.0) | 56.2 (16.4) |
| Musculoskeletal involvement, %† | 28.6 | 18.6 | 21.3 | 98.3 | 95.6 | 96.2 |
| Mucocutaneous involvement, %† | 38.1 | 32.2 | 33.8 | 77.6 | 75.6 | 76.1 |
| Proteinuria (>0.5 g), % | 100 | 94.9 | 96.3 | 0.0 | 1.7 | 1.3 |
| Serum creatine (mg/dL), mean (SD) | 1.0 (0.4) | 1.0 (0.6) | 1.0 (0.5) | 0.8 (0.2) | 0.8 (0.2) | 0.8 (0.2) |
| Serum C reactive protein (mg/dL), mean (SD) | 0.4 (0.56) | 0.63 (1.08) | 0.57 (0.97) | 0.42 (0.6) | 0.81 (1.43) | 0.71 (1.29) |
*Hispanic defined as a person of self-declared race other than black or white, and self-declared ethnicity Hispanic or Latino.
†BILAG index scores of A, B or present on SELENA-SLEDAI.
‡LUNAR patients missing an ISM score were not included.
§P=0.0042, ISM-Low versus ISM-High.
BILAG, British Isles Lupus Assessment Group; ISM, interferon signature metric; LN, lupus nephritis; N/A, not applicable; PGA, Physician Global Assessment; SELENA, Safety of Estrogen in Lupus Erythematosus-National Assessment; SLE, systemic lupus erythematosus; SLEDAI, Systemic Lupus Erythematosus Disease Activity Index.