Table 1.
SLE disease activity at baseline in TULIP-1 stratified by BICLA/SRI(4) response
| Baseline disease characteristic | Concordant outcomes | Discordant outcomes | All patients | |||||||
| BICLA−/SRI(4)− | BICLA+/SRI(4)+ | BICLA+/SRI(4)− | BICLA−/SRI(4)+ | |||||||
| Placebo (n=101) | Anifrolumab 300 mg (n=83) |
Placebo (n=51) | Anifrolumab 300 mg (n=76) |
Placebo (n=4) | Anifrolumab 300 mg (n=9) |
Placebo (n=28) | Anifrolumab 300 mg (n=12) |
Placebo (n=184) | Anifrolumab 300 mg (n=180) |
|
| SLEDAI-2K | ||||||||||
| Mean (SD) | 11.9 (3.9) | 11.6 (4.4) | 10.9 (3.0) | 10.6 (3.1) | 8.5 (1.0) | 9.9 (1.8) | 11.4 (3.0) | 15.1 (6.1) | 11.5 (3.5) | 11.3 (4.0) |
| ≥10 points, n (%) | 76 (75.2) | 60 (72.3) | 34 (66.7) | 50 (65.8) | 1 (25.0) | 5 (55.6) | 24 (85.7) | 10 (83.3) | 135 (73.4) | 125 (69.4) |
| BILAG-2004 | ||||||||||
| Global score, mean (SD) | 18.7 (5.9) | 20.7 (6.8) | 19.6 (4.8) | 18.5 (5.2) | 16.5 (7.3) | 21.6 (6.7) | 18.8 (4.6) | 20.9 (7.5) | 18.9 (5.5) | 19.8 (6.3) |
| ≥1 A, n (%) | 40 (39.6) | 42 (50.6) | 29 (56.9) | 39 (51.3) | 3 (75.0) | 8 (88.9) | 12 (42.9) | 4 (33.3) | 84 (45.7) | 93 (51.7) |
| No A and ≥2 B, n (%) | 50 (49.5) | 38 (45.8) | 20 (39.2) | 32 (42.1) | 0 (0.0) | 1 (11.1) | 14 (50.0) | 8 (66.7) | 84 (45.7) | 79 (43.9) |
| PGA score, mean (SD) | 1.84 (0.43) | 1.90 (0.40) | 1.84 (0.36) | 1.82 (0.40) | 2.08 (0.26) | 2.06 (0.38) | 1.82 (0.27) | 1.78 (0.40) | 1.84 (0.38) | 1.87 (0.40) |
| Active joint count,*† mean (SD) | 6.8 (5.0) | 7.1 (5.8) | 5.2 (3.2) | 6.6 (5.4) | 9.5 (6.4) | 9.7 (6.1) | 6.2 (4.0) | 7.9 (7.1) | 6.3 (4.5) | 7.1 (5.7) |
| Swollen joint count,* mean (SD) | 7.4 (5.3) | 7.6 (6.0) | 6.2 (3.6) | 6.8 (5.3) | 10.0 (6.8) | 9.7 (6.1) | 6.8 (4.6) | 7.9 (7.1) | 7.0 (4.8) | 7.4 (5.8) |
| Tender joint count,* mean (SD) | 11.2 (7.8) | 12.1 (7.8) | 8.6 (5.4) | 10.3 (6.5) | 15.0 (11.2) | 16.0 (8.3) | 11.1 (6.6) | 13.8 (9.7) | 10.6 (7.2) | 11.7 (7.5) |
BICLA– and SRI(4)– refer to non-responders; BICLA+ and SRI(4)+ refer to responders.
*The joint count was based on 28 joints.
†An active joint for the SLEDAI-2K calculation was defined as a joint with tenderness and swelling.
BICLA, British Isles Lupus Assessment Group-based Composite Lupus Assessment; BILAG-2004, British Isles Lupus Assessment Group-2004; PGA, Physician’s Global Assessment; SLEDAI-2K, Systemic Lupus Erythematosus Disease Activity Index 2000; SRI(4), Systemic Lupus Erythematosus Responder Index of ≥4.