Table 1.
Demographics and baseline disease characteristics
| Tofacitinib 5 mg two times per day (N=133) | Placebo (N=136) |
|
| Male, n (%) | 116 (87.2) | 108 (79.4) |
| Age (years), mean (SD) | 42.2 (11.9) | 40.0 (11.1) |
| Race, n (%) | ||
| White | 107 (80.5) | 106 (77.9) |
| Asian | 25 (18.8) | 30 (22.1) |
| Not reported | 1 (0.8) | 0 |
| Region, n (%) | ||
| North America* | 16 (12.0) | 11 (8.1) |
| European Union† | 51 (38.3) | 55 (40.4) |
| Asia‡ | 23 (17.3) | 30 (22.1) |
| Rest of the world§ | 43 (32.3) | 40 (29.4) |
| BMI, mean (SD) | 26.7 (5.7)¶ | 26.3 (5.8) |
| Smoking status | ||
| Never smoked | 75 (56.4) | 72 (52.9) |
| Former smoker | 24 (18.0) | 19 (14.0) |
| Current smoker | 34 (25.6) | 45 (33.1) |
| AS disease duration since symptoms (years), mean (SD) | 14.2 (9.8) | 12.9 (9.5) |
| AS disease duration since diagnosis (years), mean (SD) | 8.9 (9.1) | 6.8 (6.9) |
| History of uveitis, n (%) | 22 (16.5) | 20 (14.7) |
| Current diagnosis of uveitis with history of uveitis, n (%) |
6 (4.5) | 5 (3.7) |
| History of psoriasis, n (%) | 5 (3.8) | 3 (2.2) |
| Current diagnosis of psoriasis with history of psoriasis, n (%) |
2 (1.5) | 2 (1.5) |
| History of IBD, n (%) | 1 (0.8) | 2 (1.5) |
| Current diagnosis of IBD with history of IBD, n (%) |
1 (0.8) | 1 (0.7) |
| History of peripheral arthritis, n (%) | 21 (15.8) | 25 (18.4) |
| Current diagnosis of peripheral arthritis with history of peripheral arthritis, n (%) | 18 (13.5) | 22 (16.2) |
| HLA-B27-positive, n (%) | 117 (88.0) | 118 (86.8) |
| hsCRP | ||
| Mean mg/dL (SD) | 1.64 (1.73) | 1.80 (1.97) |
| ≤5 mg/L, n (%) | 41 (30.8) | 33 (24.3) |
| >5 mg/L, n (%) | 92 (69.2) | 103 (75.7) |
| ASDAS, mean (SD) | 3.8 (0.8) | 3.9 (0.8) |
| BASDAI (NRS 0–10), mean (SD) |
6.4 (1.5) | 6.5 (1.4) |
| Morning stiffness (inflammation; NRS 0–10),** mean (SD) |
6.6 (1.9) | 6.8 (1.9) |
| BASMI, mean (SD) | 4.5 (1.7) | 4.4 (1.8) |
| BASFI (NRS 0–10), mean (SD) | 5.8 (2.3) | 5.9 (2.1) |
| FACIT-F total score, mean (SD) | 27.2 (10.7) | 27.4 (9.3) |
| ASQoL, mean (SD) | 11.6 (4.7) | 11.3 (4.2) |
| SF-36v2 PCS score, mean (SD) | 33.5 (7.3) | 33.1 (7.0)†† |
| PtGA (NRS 0–10), mean (SD) | 6.9 (1.8) | 7.0 (1.7) |
| Total back pain (NRS 0–10), mean (SD) | 6.9 (1.5) | 6.9 (1.6) |
| Presence of enthesitis based on MASES >0, n (%) |
71 (53.4) | 81 (59.6) |
| MASES,‡‡ mean (SD) | 3.7 (2.5) | 3.6 (2.4) |
| Presence of swollen joints based on SJC(44) >0, n (%) | 33 (24.8) | 38 (27.9) |
| SJC(44),§§ mean (SD) | 3.4 (3.0) | 4.1 (5.2) |
| Prior NSAID use, n (%) | 133 (100.0) | 135 (99.3)¶¶ |
| Prior bDMARD use, n (%) | ||
| bDMARD-naïve | 102 (76.7) | 105 (77.2) |
| TNFi-IR*** or prior bDMARD use without IR | 31 (23.3) | 31 (22.8) |
| 1 TNFi-IR | 23 (17.3) | 20 (14.7) |
| 2 TNFi-IR | 6 (4.5) | 10 (7.4) |
| Prior bDMARD use without IR | 2 (1.5) | 1 (0.7) |
| Concomitant medication use on day 1, n (%) | ||
| NSAIDs | 106 (79.7) | 108 (79.4) |
| Oral corticosteroids | 13 (9.8) | 7 (5.1) |
| csDMARDs | 29 (21.8) | 44 (32.4) |
| Methotrexate | 5 (3.8) | 13 (9.6) |
| Sulfasalazine | 24 (18.0) | 31 (22.8) |
Data are from the week 48 final analysis.
*Canada and USA.
†Bulgaria, Czech Republic, France, Hungary and Poland.
‡China and South Korea.
§Australia, Russia, Turkey and Ukraine.
¶N1=132.
**Morning stiffness (inflammation) assessed as mean of questions 5 and 6 of the BASDAI.
††N1=135.
‡‡In patients with baseline MASES >0.
§§In patients with SJC(44) >0.
¶¶One patient did not take prior NSAIDs due to medical history.
***Patients designated as TNFi-IR must have had an IR to at least one, but not more than two, approved TNFi.
AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score using hsCRP; ASQoL, Ankylosing Spondylitis Quality of Life; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI, Bath Ankylosing Spondylitis Functional Index; BASMI, Bath Ankylosing Spondylitis Metrology Index; bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; csDMARD, conventional synthetic disease-modifying antirheumatic drug; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HLA-B27, human leucocyte antigen-B27; hsCRP, high-sensitivity C-reactive protein; IBD, inflammatory bowel disease; IR, inadequate response or intolerance; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; N, number of patients in safety analysis set; N1, number of patients with observation at visit; n, number of patients with the characteristic; NRS, Numerical Rating Scale; NSAID, non-steroidal anti-inflammatory drug; SF-36v2 PCS, Short Form-36 Health Survey Version 2 Physical Component Summary; PtGA, Patient Global Assessment of Disease Activity; SJC(44), swollen joint count in 44 joints; TNFi, tumour necrosis factor inhibitor.