Table 1.
Mean baseline values and LSM changes from baseline to month 3 for PROs
| Baseline, mean (SD) | Month 3 LSM change from baseline (SE) | |||||
| Tofacitinib 5 mg twice daily (N=131) |
Tofacitinib 10 mg twice daily (N=132) |
Placebo (N=131) |
Tofacitinib 5 mg twice daily (N=131) |
Tofacitinib 10 mg twice daily (N=132) |
Placebo (N=131) |
|
| PtGA-VAS (mm) | 57.42 (22.89) | 58.52 (22.26) | 55.76 (23.73) | −21.59 (2.23)*** | −19.88 (2.25)*** | −7.14 (2.25) |
| Pain-VAS (mm) | 56.35 (24.13) | 59.45 (22.30) | 54.91 (25.27) | −21.66 (2.16)*** | −20.88 (2.19)*** | −7.72 (2.18) |
| HAQ-DI | 1.26 (0.69) | 1.37 (0.61) | 1.25 (0.76) | −0.39 (0.05)*** | −0.35 (0.05)*** | −0.14 (0.05) |
| PGJS-VAS (mm) | ||||||
| Arthritis and psoriasis | 65.37 (21.31) | 68.16 (21.31) | 62.85 (24.38) | −26.35 (2.17)*** | −28.22 (2.22)*** | −10.56 (2.21) |
| Arthritis | 66.62 (20.61) | 67.88 (22.41) | 62.65 (24.62) | −25.11 (2.25)*** | −26.69 (2.29)*** | −11.48 (2.29) |
| Psoriasis | 53.50 (29.54) | 58.88 (29.38) | 54.63 (28.69) | −22.42 (2.29)*** | −27.61 (2.34)*** | −7.65 (2.33) |
| SF-36v2 PCS score | 33.57 (8.46) | 31.73 (8.93) | 34.70 (9.55) | 5.18 (0.68)*** | 5.34 (0.69)*** | 1.77 (0.69) |
| SF-36v2 MCS score | 39.76 (12.64) | 39.84 (12.28) | 40.59 (12.66) | 4.94 (0.88) | 4.28 (0.88) | 2.97 (0.88) |
| SF-36v2 norm-based domain scores | ||||||
| PF | 33.45 (10.43) | 32.12 (9.87) | 34.03 (10.99) | 5.00 (0.72)** | 4.08 (0.73)* | 1.69 (0.73) |
| RP | 34.63 (10.34) | 32.69 (9.25) | 35.86 (10.69) | 4.99 (0.81) | 5.44 (0.81)* | 2.85 (0.81) |
| BP | 33.24 (7.88) | 32.63 (6.94) | 35.42 (8.73) | 7.00 (0.79)*** | 7.59 (0.80)*** | 2.10 (0.80) |
| GH | 34.71 (8.71) | 33.53 (9.29) | 35.60 (10.09) | 3.67 (0.64) | 3.92 (0.65) | 2.45 (0.65) |
| VT | 39.70 (10.22) | 38.51 (9.02) | 40.25 (10.73) | 4.95 (0.83)* | 4.75 (0.84)* | 2.41 (0.84) |
| SF | 36.46 (11.47) | 35.26 (11.12) | 37.56 (11.81) | 6.25 (0.84)** | 5.46 (0.86)* | 2.89 (0.86) |
| RE | 35.50 (13.95) | 35.49 (13.49) | 36.03 (14.12) | 5.44 (1.00) | 4.84 (1.00) | 3.85 (1.00) |
| MH | 38.33 (11.84) | 38.90 (10.97) | 40.19 (12.45) | 4.36 (0.85) | 4.11 (0.87) | 2.11 (0.87) |
| FACIT-Fatigue | ||||||
| Total score | 26.1 (12.15) | 26.1 (10.27) | 27.5 (11.58) | 7.0 (0.81)*** | 5.8 (0.82)* | 3.0 (0.82) |
| Experience domain score | 8.2 (5.07) | 8.1 (4.29) | 8.6 (4.80) | 3.1 (0.38)** | 2.6 (0.39)* | 1.5 (0.39) |
| Impact domain score | 17.8 (7.56) | 18.0 (6.48) | 18.9 (7.36) | 3.9 (0.48)*** | 3.2 (0.49)* | 1.6 (0.49) |
| EQ-5D-3L dimension scores | ||||||
| Mobility | 1.68 (0.47) | 1.78 (0.42) | 1.71 (0.46) | −0.17 (0.04)* | −0.15 (0.04) | −0.05 (0.04) |
| Self-care | 1.46 (0.50) | 1.61 (0.49) | 1.50 (0.56) | −0.15 (0.04) | −0.15 (0.04) | −0.04 (0.04) |
| Usual activities | 1.91 (0.46) | 1.98 (0.43) | 1.92 (0.49) | −0.23 (0.04) | −0.22 (0.04) | −0.15 (0.04) |
| Pain/discomfort | 2.24 (0.46) | 2.27 (0.46) | 2.21 (0.46) | −0.32 (0.04)** | −0.29 (0.04)** | −0.12 (0.04) |
| Anxiety/depression | 1.69 (0.60) | 1.73 (0.57) | 1.73 (0.71) | −0.19 (0.04) | −0.20 (0.05) | −0.12 (0.05) |
| EQ-VAS (mm) | 51.98 (22.30) | 48.83 (21.49) | 53.39 (22.34) | 8.62 (1.85)* | 12.33 (1.90)*** | 2.64 (1.90) |
| ASQoL | 11.4 (4.83) | 12.2 (4.45) | 10.7 (5.20) | −3.8 (0.38)*** | −3.5 (0.39)*** | −1.5 (0.40) |
N is the number of patients per group in the Full Analysis Set; the number of patients evaluable for each baseline characteristic may be fewer than N.
*p≤0.05, **p<0.01, ***p<0.001 compared with placebo; results at month 3 were based on a repeated -measures model including data up to month 3 for tofacitinib 5 mg twice daily, tofacitinib 10 mg twice daily and combined placebo group without imputation for missing values.
ASQoL, Ankylosing Spondylitis Quality of Life; BP, bodily pain; EQ-5D-3L, EuroQol 5-Dimensions-3-level; EQ-VAS, EuroQol Health State visual analogue scale; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; GH, general health; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCS, Mental Component Summary; MH, mental health; PCS, Physical Component Summary; PF, physical functioning; PGJS, Patient Global Joint Skin Assessment; PRO, patient-reported outcome; PtGA, Patient Global Assessment of disease activity; RE, role emotional; RF, role physical; SF, social functioning; SF-36v2, Short Form-36 Health Survey version 2; VAS, visual analogue scale; VT, vitality.