Table 1

SLE disease activity at baseline in TULIP-1 stratified by BICLA/SRI(4) response

Baseline disease characteristicConcordant outcomesDiscordant outcomesAll 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.