Baseline serological characteristics versus ISM status for patients from the Rontalizumab Phase I, rituximab EXPLORER, rituximab LUNAR and rontalizumab Phase II ROSE studies
| Phase I Study | EXPLORER Study | |||||||
|---|---|---|---|---|---|---|---|---|
| Serology parameter | ISM-Low (n=32) | ISM-High (n=28) | Total (N=60) | Serology Parameter | ISM-Low (n=40) | ISM-High (n=95) | Total (N=135) | |
| C3 (mg/dL), mean (SD) | 133.5 (29.6) | 120.6 (36.1) | 128.7 (28.1) | C3 (mg/dL), mean (SD) | 120.6 (36.1) | 92.7 (30.9) | 100.9 (34.9) | |
| C4 (mg/dL), mean (SD) | 25.3 (7.7) | 21.2 (9.1) | 23.4 (7.4) | C4 (mg/dL), mean (SD) | 20.2 (9.1) | 13.6 (7.2) | 15.5 (8.3) | |
| Anti-dsDNA (IU/mL), median (IQR) | 12 (12–15) | 15 (12–45) | 12 (12–23) | Anti-dsDNA (IU/mL), median (IQR) | 12 (12–79) | 71 (29–239) | 44 (13–224) | |
| Anti-dsDNA+ (≥30 U/mL), % | 9.4 | 32.1 | 20.0 | Anti-dsDNA+ (≥30 U/mL), % | 35.0 | 72.6 | 61.5 | |
| Anti-ENA+, %* | 6.3 | 60.7 | 31.7 | Anti-ENA+, %* | 10.0 | 59.6 | 44.8 | |
| Anti-SSA/Ro52+ (≥120 IU/mL), % | 3.1 | 46.4 | 23.2 | Anti-SSA/Ro52+ (≥120 IU/mL), % | 7.5 | 41.5 | 31.3 | |
| Anti-SSB/La+ (≥120 IU/mL), % | 0.0 | 7.1 | 3.3 | Anti-SSB/La+ (≥120 IU/mL), % | 0.0 | 17.0 | 11.9 | |
| Anti-RNP+ (≥120 IU/mL), % | 3.1 | 21.4 | 11.7 | Anti-RNP+ (≥120 IU/mL), % | 2.5 | 26.6 | 19.4 | |
| Anti-Sm+ (≥120 IU/mL), % | 0.0 | 10.7 | 5.0 | Anti-Sm+ (≥ 120 IU/mL), % | 2.5 | 23.4 | 17.2 | |
| BAFF† (IU/mL), median (IQR) | 1782 (1468–2202) | 2542 (1842–3031) | 1975 (1589–2862) | BAFF† (IU/mL), median (IQR) | 2085 (1630–2735) | 3750 (2250–6690) | 2870 (2000–4960) | |
| LUNAR study | ROSE study | |||||||
|---|---|---|---|---|---|---|---|---|
| Serology parameter | ISM-Low (n=21) | ISM-High (n=59) | Total (N=80) | Serology Parameter | ISM-Low (n=58) | ISM-High (n=180) | Total (N=238) | p Value‡ |
| C3 (mg/dL), mean (SD) | 77.7 (32.0) | 75.0 (30.2) | 75.7 (30.5) | C3 (mg/dL), mean (SD) | 121.7 (30.7) | 95.8 (32.6) | 102.1 (34.0) | <0.0001 |
| C4 (mg/dL), mean (SD) | 13.7 (8.4) | 14.3 (7.8) | 14.2 (7.9) | C4 (mg/dL), mean (SD) | 21.4 (8.5) | 14.5 (9.9) | 16.2 (10.0) | <0.0001 |
| Anti-dsDNA (IU/mL), median (IQR) | 66 (23–209) | 154 (57–347) | 116 (39–303) | Anti-dsDNA (IU/mL), median (IQR) | 12 (12–36) | 91 (24–273) | 53 (14–193) | <0.0001 |
| Anti-dsDNA+ (≥30 U/mL), % | 57.1 | 84.4 | 77.5 | Anti-dsDNA+ (≥ 30 U/mL), % | 34.5 | 70.9 | 62.0 | <0.0001 |
| Anti-ENA+, %* | 52.4 | 57.6 | 56.3 | Anti-ENA+, %* | 19.0 | 73.3 | 60.1 | <0.0001 |
| Anti-SSA/Ro52+ (≥120 IU/mL), % | 23.8 | 25.4 | 25.0 | Anti-SSA/Ro52+ (≥ 120 IU/mL), % | 13.8 | 49.4 | 40.8 | <0.0001 |
| Anti-SSB/La+ (≥120 IU/mL), % | 9.5 | 8.5 | 8.8 | Anti-SSB/La+ (≥ 120 IU/mL), % | 5.2 | 16.1 | 13.4 | 0.0443 |
| Anti-RNP+ (≥120 IU/mL), % | 23.8 | 35.6 | 32.5 | Anti-RNP+ (≥ 120 IU/mL), % | 8.6 | 37.8 | 30.7 | <0.0001 |
| Anti-Sm+ (≥120 IU/mL), % | 28.6 | 30.5 | 30.0 | Anti-Sm+ (≥120 IU/mL), % | 0.0 | 28.3 | 21.4 | <0.0001 |
| BAFF† (IU/mL), median (IQR) | 1860 (1590–2940) | 3550 (2330–5700) | 3010 (1960–5080) | BAFF (IU/mL), median (IQR) | 1935 (1565–2590) | 2990 (2180–4120) | 2660 (1940–3890) | <0.0001 |
ENA, extractable nuclear antigen; ISM, interferon signature metric; IU, international unit.
*Positive for two or more autoantigen reactivities of the following: SM+, RNP+, SSA+, SSB+.
†For Phase I, BAFF data are available for n=28 patients (14 ISM-Low, 14 ISM-High).
‡p Value represents ISM-Low versus ISM-High.