Baseline | 3 Months | |||||
---|---|---|---|---|---|---|
IR switchers (n=30) | AE switchers (n=44) | p Value* | IR switchers (n=23) | AE switchers (n=39) | p Value† | |
BASDAI 50 (n (%))‡ | – | – | – | 4 (21.1) | 9 (33.3) | 0.36 |
ASAS20 (n (%))‡ | – | – | – | 6 (31.6) | 12 (46.2) | 0.32 |
ASAS40 (n (%))‡ | – | – | – | 6 (31.6) | 8 (30.8) | 0.95 |
BASFI (0–10)‡ | 4.8 (2.7–6.7) | 5.6 (2.9–7.3) | 0.41 | 3.8 (2.0–5.8) | 2.9 (1.4–5.7) | 0.57 |
BASDAI (0–10)‡ | 6.1 (3.8–7.2) | 5.7 (4.0–7.6) | 0.42 | 3.9 (1.8–6.5) | 4.2 (2.9–5.3) | 0.37 |
ASDAS‡ | 3.65 (2.81–4.17) | 3.71 (2.87–4.46) | 0.97 | 2.62 (1.55–3.27) | 1.98 (1.52–3.39) | 0.16 |
ESR (mm/h) | 14 (6–37) | 23 (5–40) | 0.87 | 8 (4–27) | 10 (4–16) | 0.03 |
CRP (mg/l) | 12 (5–32) | 10 (5–27) | 0.81 | 5 (2–11) | 5 (4–7) | 0.10 |
Patient global VAS (mm) | 59 (33–82) | 61 (37–79) | 0.85 | 31 (20–53) | 37 (17–59) | 0.98 |
Pain VAS (mm) | 60 (47–73) | 53 (39–73) | 0.40 | 32 (21–52) | 33 (11–56) | 0.89 |
Fatigue VAS (mm) | 58 (40–76) | 64 (37–80) | 0.67 | 48 (21–73) | 50 (23–76) | 0.92 |
Physician global VAS (mm) | 31 (25–63) | 39 (24–58) | 0.89 | 24 (12–34) | 17 (8–30) | 0.48 |
SF-36 PCS | 29 (25–36) | 28 (23–35) | 0.29 | 37 (27–43) | 33 (27–42) | 0.37 |
SF-36 MCS | 43 (34–55) | 44 (36–54) | 0.94 | 49 (38–58) | 49 (32–57) | 0.37 |
SF-6D | 0.55 (0.46–0.65) | 0.56 (0.51–0.64) | 0.67 | 0.68 (0.55–0.76) | 0.62 (0.51–0.72) | 0.54 |
Values are median (IQR) unless otherwise indicated.
↵* Mann–Whitney U test.
↵† χ2test/ranked analysis of covariance adjusted for baseline.
↵‡ BASDAI, BASDAI and ASDAS data and ASAS responses were not available for all patients (see details in text).
AE, adverse event; ASDAS, Ankylosing Spondylitis Disease Activity Score; ASAS, Assessments of Spondyloarthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; CRP, C reactive protein; ESR, erythrocyte sedimentation rate; IR, insufficient response; MCS, mental components summary; PCS, physical components summary; SF-36, 36-item Short-Form Health Survey; TNFi, tumour necrosis factor inhibitor; VAS, Visual Analogue Scale.