Table 1.
Patient demographics and baseline disease characteristics
| Mean (SD), unless otherwise stated | BE MOBILE 1 (nr-axSpA) n=254 | BE MOBILE 2 (r-axSpA) n=332 |
| Patient demographics | ||
| Sex, male, n (%) | 138 (54.3) | 240 (72.3) |
| Age, years | 39.4 (11.5) | 40.4 (12.3) |
| HLA-B27 positive, n (%) | 197 (77.6) | 284 (85.5) |
| BMI, kg/m2 | 27.4 (5.8) | 26.9 (5.8) |
| Baseline disease characteristics | ||
| Time since first symptoms of axSpA, years | 9.0 (8.8) | 13.5 (10.3) |
| ASDAS | 3.7 (0.7) | 3.7 (0.8) |
| ASDAS disease status | ||
| ASDAS-vHDA, n (%) ASDAS-HDA, n (%) ASDAS-LDA, n (%) ASDAS-ID, n (%) Missing, n (%) |
148 (58.3) 102 (40.2) 4 (1.6) 0 (0.0) 0 (0.0) |
197 (59.5) 131 (39.6) 3 (0.9) 0 (0.0) 1 (0.3) |
| BASDAI | 6.8 (1.3) | 6.5 (1.3) |
| BASFI | 5.4 (2.3) | 5.2 (2.1) |
| hs-CRP, mg/L, geometric mean (geometric CV, %) | 4.8 (261.8) | 6.6 (246.3) |
| hs-CRP>ULN,* n (%) | 141 (55.5) | 204 (61.4) |
| Total spinal pain | 7.2 (1.5) | 7.2 (1.5) |
| FACIT-Fatigue | 30.1 (10.7) | 31.5 (10.7) |
| BASDAI Q1 (fatigue) | 6.6 (1.7) | 6.4 (1.5) |
| SF-36 PCS | 33.4 (8.5) | 34.4 (8.5)† |
| EQ-5D-3L utility | 0.53 (0.28) | 0.54 (0.29)† |
| ASQoL | 9.4 (4.5) | 8.9 (4.6) |
| MOS-Sleep-R Index II | 43.1 (9.0) | 44.2 (9.3)† |
| WPAI-axSpA | ||
| % presenteeism % absenteeism % overall work impairment % activity impairment |
48.2 (23.0)‡ 12.2 (25.8)¶ 50.6 (24.2)‡ 55.4 (22.3) |
44.8 (24.4)§ 11.3 (24.7)** 47.5 (25.3)§ 53.4 (23.7)† |
| Prior TNFi exposure, n (%) | 27 (10.6) | 54 (16.3) |
| Concomitant medication use, n (%) | ||
| NSAIDs Oral glucocorticoids csDMARDs |
189 (74.4) 21 (8.3) 61 (24.0) |
266 (80.1) 23 (6.9) 66 (19.9) |
Randomised set. Data pooled by study. WPAI-axSpA item scores are expressed as a percentage, with higher numbers indicating greater impairment and less productivity.
*ULN value for hs-CRP is 5 mg/L.
†n=331.
‡n=170.
§n=223.
¶n=188.
**n=242.
ASDAS, Ankylosing Spondylitis Disease Activity Score; ASDAS-HDA, ASDAS high disease activity; ASDAS-ID, ASDAS inactive disease; ASDAS-LDA, ASDAS low disease activity; ASDAS-vHDA, ASDAS very high disease activity; ASQoL, Ankylosing Spondylitis Quality of Life; axSpA, axial spondyloarthritis; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; CV, coefficient of variation; EQ-5D-3L, European Quality of Life 5 Dimensions 3 Level Version; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy – Fatigue; HLA-B27, human leukocyte antigen-B27; hs-CRP, high-sensitivity C-reactive protein; MOS-Sleep R, Medical Outcomes Study Sleep scale Revised; n, number; nr-axSpA, non-radiographic axSpA; NSAID, non-steroidal anti-inflammatory drug; Q, question; r-axSpA, radiographic axSpA; SF-36 PCS, Short Form-36 Physical Component Summary; TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal; WPAI-axSpA, Work Productivity and Activity in axSpA.