Table 1.
Guselkumab 100 mg | Placebo | ||
---|---|---|---|
Q4W | Q8W | ||
Patients, N | 82 | 68 | 96 |
Sex | |||
Female, n (%) | 28 (34.1) | 28 (41.2) | 37 (38.5) |
Male, n (%) | 54 (65.9) | 40 (58.8) | 59 (61.5) |
Age, years | 44.2 ± 12.0 | 45.0 ± 10.7 | 44.2 ± 11.3 |
Race | |||
Asian | 0 | 1 (1.5) | 0 |
White | 82 (100.0) | 67 (98.5) | 96 (100.0) |
Age, years | 44.2 ± 12.0 | 45.0 ± 10.7 | 44.2 ± 11.3 |
BMI | 27.7 ± 5.9 | 28.0 ± 6.5 | 28.4 ± 6.5 |
PsA duration, years | 5.2 ± 5.7 | 4.9 ± 5.4 | 5.8 ± 5.2 |
BASDAI | |||
Patients | 79 | 62 | 89 |
Total | 6.5 ± 1.6 | 6.6 ± 1.9 | 6.6 ± 1.6 |
Fatigue (Q#1) | 6.4 ± 1.9 | 6.7 ± 1.9 | 6.5 ± 1.8 |
Spinal pain (Q#2) | 6.5 ± 2.2 | 6.6 ± 2.2 | 6.7 ± 1.9 |
Joint pain (Q#3) | 6.4 ± 1.9 | 6.6 ± 2.1 | 6.8 ± 1.8 |
Enthesitis (Q#4) | 6.3 ± 2.0 | 6.6 ± 2.3 | 6.4 ± 2.2 |
Qualitative morning stiffness (Q#5) | 6.9 ± 2.0 | 7.0 ± 2.5 | 7.0 ± 2.0 |
Quantitative morning stiffness (Q#6) | 6.4 ± 2.8 | 6.0 ± 2.7 | 6.3 ± 2.8 |
ASDAS | 3.9 ± 0.8 | 4.1 ± 1.0 | 4.0 ± 0.8 |
Swollen joint count (0–66) | 13.4 ± 9.1 | 11.3 ± 5.6 | 11.4 ± 7.1 |
Tender joint count (0–68) | 24.7 ± 15.7 | 21.2 ± 12.4 | 21.5 ± 13.2 |
Patients with enthesitis, n (%) | 65 (79.3) | 53 (77.9) | 70 (72.9) |
Enthesitis score (LEI, 0–6)* | 2.8 ± 1.8 | 2.6 ± 1.5 | 2.8 ± 1.7 |
Patients with dactylitis, n (%) | 49 (59.8) | 37 (54.4) | 42 (43.8) |
Dactylitis score (0–60) | 9.0 ± 10.0 | 9.1 ± 9.4 | 8.0 ± 8.3 |
HLA-B*27+ , n/N (%) | 19/48 (39.6) | 12/38 (31.6) | 17/63 (27.0) |
Data presented as mean ± standard deviation unless otherwise noted
*n = 64 in the Q4W group
ASDAS Ankylosing Spondylitis Disease Activity Score, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BMI body mass index, LEI Leeds Enthesitis Index, PsA psoriatic arthritis, Q Question, Q4W/Q8W every 4/8 weeks