Table 1.
Baseline characteristics of the study population by treatment group
| Peripheral SpA | Axial SpA | |||
|---|---|---|---|---|
| Nilotinib (n = 5) | Placebo (n = 8) | Nilotinib (n = 8) | Placebo (n = 9) | |
| Age, median (IQR) years | 39.5 (37.4–52.3) | 47.1 (31.8–60.4) | 38.0 (36.1–42.4) | 40.1 (34.5–46.7) |
| Disease duration, median (IQR) years | 4.6 (1.0–9.4) | 8.4 (4.4–11.5) | 5.8 (1.8–15.3) | 4.0 (1.6–12.7) |
| Number of men/women | 3/2 | 4/4 | 7/1 | 6/3 |
| Inflammatory back pain (history/presence), n (%) | 0 (0.0) | 3 (37.5) | 8 (100.0) | 9 (100.0) |
| Peripheral arthritis (history/presence), n (%) | 5 (100.0) | 8 (100.0) | 3 (37.5) | 3 (33.3) |
| Enthesitis (history/presence), n (%) | 0 (0.0) | 3 (37.5) | 3 (37.5) | 6 (66.7) |
| Dactylitis (history/presence), n (%) | 1 (20.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Patient’s global assessment, median (IQR) mm | 52.0 (42.5–64.5) | 63.5 (50.8–82.5) | 67.0 (49.8–70.8) | 70.0 (59.5–86.0) |
| Physician’s global assessment, median (IQR) mm | 46.0 (43.5–64.5) | 55.5 (49.0–59.5) | 56.5 (47.3–58.0) | 55.0 (50.0–60.0) |
| 66 Swollen joint count, median (IQR) | 9.0 (3.0–17.5) | 3.5 (1.0–8.0) | NA | NA |
| 68 Tender joint count, median (IQR) | 8.0 (0.5–19.5) | 9.5 (3.5–11.8) | NA | NA |
| BASDAI, median (IQR) | NA | NA | 5.9 (4.2–6.9) | 5.4 (4.9–6.8) |
| CRP, median (IQR) mg/l | 9.2 (0.6–29.5) | 14.8 (3.0–51.7) | 4.8 (3.2–5.4) | 6.3 (2.6–15.2) |
| ESR, median (IQR) mm/h | 7.0 (3.5–31.5) | 10.5 (5.0–42.3) | 8.5 (2.0–12.0) | 16.0 (3.5–36.5) |
| Concomitant NSAIDs, n (%) | 4 (80.0) | 6 (75.0) | 8 (100.0) | 9 (100.0) |
| Concomitant corticosteroids, n (%) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Concomitant methotrexate, n (%) | 2 (40.0) | 4 (50.0) | 2 (25.0) | 0 (0.0) |
| Concomitant sulfasalazine, n (%) | 2 (40.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) |
| Previous anti-TNF treatment, n (%) | 1 (20.0) | 2 (25.0) | 2 (25.0) | 2 (22.2) |
Significance of the comparisons is determined by Mann–Whitney U test for continuous variables and Fisher’s exact test for categorical variables. There were no significant differences between the nilotinib and placebo groups
SpA spondyloarthritis; IQR interquartile range; BASDAI bath ankylosing spondylitis disease activity Index; CRP C-reactive protein; ESR erythrocyte sedimentation rate; NSAIDs non-steroidal anti-inflammatory drugs; TNF tumor necrosis factor; NA not applicable