Table 1.
Patient demographics and baseline disease characteristics by treatment group and background MTX dose
| Tofacitinib 5 mg BID | Tofacitinib 10 mg BID | Placebo | ||||
|---|---|---|---|---|---|---|
| MTX dose ≤ 15 mg/week (N = 116)a | MTX dose > 15 mg/week (N = 70)a | MTX dose ≤ 15 mg/week (N = 122)a | MTX dose > 15 mg/week (N = 56)a | MTX dose ≤ 15 mg/week (N = 133)a | MTX dose > 15 mg/week (N = 59)a | |
| Female, n (%) | 50 (43.1) | 43 (61.4) | 71 (58.2) | 31 (55.4) | 71 (53.4) | 35 (59.3) |
| Age (years), mean (SD) | 49.9 (12.6) | 49.8 (11.8) | 48.7 (10.4) | 47.4 (13.3) | 49.8 (12.4) | 46.0 (12.7) |
| White, n (%) | 111 (95.7) | 67 (95.7) | 112 (91.8) | 53 (94.6) | 125 (94.0) | 57 (96.6) |
| Duration of PsA (years), mean (SD) | 8.8 (7.9) | 9.1 (8.7) | 7.0 (6.3) | 7.4 (6.9) | 8.6 (8.3) | 6.7 (5.1) |
| BMI (kg/m2), mean (SD) | 29.6 (5.7) | 29.5 (6.4) | 29.6 (6.1) | 31.0 (5.9) | 29.6 (5.6) | 28.5 (5.7) |
| Number of swollen joints, median (range)b | 9.5 (0–60) | 9.5 (2–38) | 9.0 (3–60) | 8.0 (3–54) | 9.0 (0–49) | 7.0 (3–32) |
| Number of tender/painful joints, median (range)c | 18.0 (4–68) | 19.0 (3–54) | 16.5 (3–66) | 18.0 (3–59) | 17.0 (4–66) | 13.0 (3–61) |
| PASI score | ||||||
| Patients includedd n (%) | 84 (72.4) | 46 (65.7) | 81 (66.4) | 36 (64.3) | 99 (74.4) | 40 (67.8) |
| Mean (SD) [range] | 10.4 (8.4) [0.6–46.0] | 7.1 (6.9) [0.4–34.0] | 10.3 (7.5) [0.3–32.2] | 9.1 (8.1) [0.8–28.0] | 10.9 (10.7) [1.6–66.0] | 8.9 (8.7) [0.8–41.4] |
| LEI score | ||||||
| Patients includede n (%) | 76 (65.5) | 45 (64.3) | 77 (63.1) | 41 (73.2) | 89 (66.9) | 38 (64.4) |
| Mean (SD) [range] | 3.1 (1.6) [1–6] | 2.3 (1.4) [1–6] | 3.2 (1.6) [1–6] | 3.1 (1.9) [1–6] | 2.7 (1.5) [1–6] | 2.8 (1.4) [1–6] |
| DSS score | ||||||
| Patients includedf n (%) | 70 (60.3) | 31 (44.3) | 73 (59.8) | 29 (51.8) | 75 (56.4) | 26 (44.1) |
| Mean (SD) [range] | 8.5 (7.8) [1–44] | 6.7 (7.1) [1–36] | 8.2 (7.4) [1–40] | 10.1 (10.1) [1–40] | 8.5 (7.0) [1–31] | 6.9 (7.7) [1–30] |
| HAQ-DI, mean (SD) [range] | 1.1 (0.7) [0.0–2.6] | 1.2 (0.6) [0.0–2.3] | 1.2 (0.6) [0.0–2.9] | 1.3 (0.6) [0.0–2.6] | 1.2 (0.7) [0.0–3.0] | 1.3 (0.6) [0.3–2.6] |
| PGA-PsA-VAS (mm), mean (SD) [range] | 65.0 (21.0) [15.0–100.0] | 60.0 (21.9) [5.0–98.0] | 66.4 (22.5) [3.0–100.0] | 59.3 (22.3) [15.0–98.0] | 61.2 (24.5) [2.0–100.0] | 62.5 (22.0) [6.0–100.0] |
| PGJS-VAS (mm), mean (SD) [range] | 53.6 (21.2) [9.0–98.0] | 51.1 (22.3) [1.0–99.0] | 53.3 (18.8) [14.0–98.0] | 55.5 (18.6) [9.8–87.0] | 54.5 (21.5) [11.0–100.0] | 57.0 (18.9) [6.9–90.0] |
| C-reactive protein (mg/L),g mean (SD) [range] | 12.2 (22.5) [0.2–126.0] | 11.9 (20.0) [0.2–115.0] | 10.2 (21.1) [0.2–163.0] | 13.4 (22.4) [0.4–134.0] | 9.7 (17.1) [0.2–107.0] | 14.1 (23.6) [0.2–164.0] |
| MTX dose (mg/week), mean (SD) [range] | 12.8 (3.0) [2.5–15.0] | 19.9 (0.8) [17.5–25.0] | 12.3 (3.3) [2.5–15.0] | 19.8 (0.7) [17.5–20.0] | 12.5 (3.1) [2.5–15.0] | 19.8 (0.7) [16.0–20.0] |
The maximum permitted dose of MTX was 20 mg/week. This analysis included all patients who received MTX as background therapy only on day 1 in the FAS. Eight patients who used both MTX and other csDMARDs on day 1 were excluded, as were two patients who exceeded the protocol-defined maximum dose of MTX for the analysis (20 mg/week), and one patient without dosing frequency to calculate the dose
BID, twice daily; BMI, body mass index; BSA, body surface area; csDMARD, conventional synthetic disease-modifying anti-rheumatic drug; DSS, Dactylitis Severity Score; FAS, full analysis set; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MTX, methotrexate or methotrexate sodium; N, number of patients in the FAS; n, number of patients; PASI, Psoriasis Area and Severity Index; PGA-PsA-VAS, physician’s global assessment of psoriatic arthritis-visual analog scale; PGJS-VAS, patient’s global joint and skin assessment-visual analog scale; PsA, psoriatic arthritis; SD, standard deviation; ULN, upper limit of normal
aN is the number of patients in the FAS; the number of patients assessed for each characteristic may be lower. bOut of 66 joints assessed. cOut of 68 joints assessed. dFor patients with baseline PASI > 0 and baseline BSA ≥ 3%. eFor patients with baseline LEI > 0. fFor patients with baseline DSS > 0. gC-reactive protein ULN 2.87 mg/L