Table 1.
Baseline demographics and patient characteristics
| N (%) unless noted | FIL 200 mg (n = 38) | LANRA 30 mg (n = 37) | TIRA 40 mg (n = 39) | PBO (n = 36) | Total (N = 150) |
|---|---|---|---|---|---|
| Age, mean (s.d.), years | 52.2 (10.5) | 56.2 (9.7) | 55.8 (10.1) | 53.2 (10.3) | 54.4 (10.2) |
| ≥50 years | 25 (65.8) | 27 (73.0) | 29 (74.4) | 26 (72.2) | 107 (71.3) |
| <50 years | 13 (34.2) | 10 (27.0) | 10 (25.6) | 10 (27.8) | 43 (28.7) |
| Sex | |||||
| Female | 38 (100) | 36 (97.3) | 37 (94.9) | 35 (97.2) | 146 (97.3) |
| Race | |||||
| White | 32 (84.2) | 31 (83.8) | 34 (87.2) | 30 (83.3) | 127 (84.7) |
| Black | 5 (13.2) | 5 (13.5) | 4 (10.3) | 5 (13.9) | 19 (12.7) |
| Asian | 1 (2.6) | 0 | 1 (2.6) | 0 | 2 (1.3) |
| American Indian or Alaska native | 0 | 0 | 0 | 1 (2.8) | 1 (0.7) |
| Other | 0 | 1 (2.7) | 0 | 0 | 1 (0.7) |
| Ethnicity | |||||
| Not Hispanic or Latino | 34 (89.5) | 31 (83.8) | 38 (97.4) | 30 (83.3) | 133 (88.7) |
| Hispanic or Latino | 4 (10.5) | 6 (16.2) | 1 (2.6) | 6 (16.7) | 17 (11.3) |
| Duration of SS, mean (s.d.) | 5.3 (6.9) | 9.4 (9.4) | 8.1 (6.2) | 8.2 (8.0) | 7.7 (7.8) |
| Concomitant autoimmune diseasea | 10 (26.3) | 14 (37.8) | 14 (35.9) | 13 (36.1) | 51 (34.0) |
| SLE or RA | 8 (21.1) | 12 (32.4) | 8 (20.5) | 10 (27.8) | 38 (25.3) |
| SLE | 4 (10.5) | 8 (21.6) | 4 (10.3) | 6 (16.7) | 22 (14.7) |
| RA | 5 (13.2) | 7 (18.9) | 5 (12.8) | 6 (16.7) | 23 (15.3) |
| ESSDAI, mean (s.d.) | 10.2 (6.23) | 10.5 (4.89) | 10.4 (5.36) | 9.3 (3.96) | 10.1 (5.16) |
| Median (range) | 10.0 (0, 39) | 10.0 (0, 22) | 9.0 (0, 22) | 9.0 (0, 18) | 9.0 (0, 39) |
| Baseline haematological + biological Component Score <2 |
23 (60.5) | 20 (54.1) | 26 (66.7) | 22 (61.1) | 91 (60.7) |
| Baseline haematological + biological Component Score ≥2 |
15 (39.5) | 17 (45.9) | 13 (33.3) | 14 (38.9) | 59 (39.3) |
| ESSPRI, mean (s.d.) | 6.3 (2.3) | 6.6 (1.9) | 5.9 (2.4) | 5.9 (2.2) | 6.2 (2.2) |
| Median (range) | 7.0 (1.7, 9.7) | 7.0 (3.3, 9.7) | 6.7 (1.7, 9.7) | 5.8 (2.3, 9.3) | 6.7 (1.7, 9.7) |
| hsCRP, mg/dL, mean (s.d.) | 0.30 (0.28) | 0.41 (0.53) | 0.36 (0.36) | 0.34 (0.52) | 0.35 (0.43) |
| hsCRP ≥1.5 × ULN | 0 | 1 (2.7) | 0 | 2 (5.6) | 3 (2.0) |
| Both SSA and SSB positiveb | 21 (55.3) | 11 (29.7) | 22 (56.4) | 20 (55.6) | 74 (49.3) |
| SSA positive | 17 (44.7) | 25 (67.6) | 17 (43.6) | 16 (44.4) | 75 (50.0) |
| Use of concurrent immunomodulatory drugsc at baseline | 24 (63.2) | 26 (70.3) | 27 (69.2) | 26 (72.2) | 103 (68.7) |
| Use of concurrent csDMARD at baseline | 23 (60.5) | 25 (67.6) | 25 (64.1) | 24 (66.7) | 97 (64.7) |
| Use of concurrent systemic CSs at baseline | 7 (18.4) | 13 (35.1) | 4 (10.3) | 11 (30.6) | 35 (23.3) |
Data presented as n (%) unless otherwise noted. Baseline characteristics are reported for all randomized patients who received at least one dose of a study drug.
aIncluding any of the following: autoimmune thyroiditis, autoimmune thyroid disorder, coeliac disease, immune thrombocytopenic purpura, psoriasis, RA, rheumatoid nodule, scleroderma, scLE, SLE, SLE rash, SSc, type I diabetes mellitus, and vitiligo.
One patient in the lanraplenib subgroup was SSB positive only.
csDMARD or systemic CSs. csDMARD: conventional synthetic DMARD; ESSDAI: EULAR SS disease activity index; ESSPRI: EULAR SS patient-reported index; FIL: filgotinib; hsCRP: high-sensitivity CRP; LANRA: lanraplenib; PBO: placebo; TIRA: tirabrutinib; ULN: upper limit of normal.