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=107) |
Tofacitinib 10 mg twice daily (N=104) |
Adalimumab 40 mg subcutaneous injection once every 2 weeks (N=106) |
Placebo (N=105) |
Tofacitinib 5 mg twice daily (N=107) |
Tofacitinib 10 mg twice daily (N=104) |
Adalimumab 40 mg subcutaneous injection once every 2 weeks (N=106) |
Placebo (N=105) |
|
| PtGA-VAS (mm) | 54.67 (22.13) | 53.60 (22.87) | 50.56 (22.99) | 53.90 (22.65) | −20.08 (2.28)** | −25.50 (2.29)*** | −21.47 (2.33)*** | −11.40 (2.44) |
| Pain-VAS (mm) | 55.74 (22.85) | 54.42 (21.63) | 50.68 (21.70) | 53.15 (23.44) | −21.49 (2.33)*** | −27.10 (2.34)*** | −21.87 (2.39)*** | −10.22 (2.50) |
| HAQ-DI | 1.16 (0.61) | 1.08 (0.60) | 1.10 (0.62) | 1.11 (0.59) | −0.35 (0.05)** | −0.40 (0.05)*** | −0.38 (0.05)** | −0.18 (0.05) |
| PGJS-VAS (mm) | ||||||||
| Arthritis and psoriasis | 61.99 (20.90) | 61.71 (23.64) | 59.75 (23.85) | 58.49 (21.51) | −27.00 (2.29)*** | −29.97 (2.29)*** | −25.91 (2.34)*** | −13.00 (2.48) |
| Arthritis | 64.77 (21.52) | 64.07 (24.29) | 60.23 (23.87) | 60.58 (22.60) | −27.66 (2.40)*** | −30.28 (2.40)*** | −26.11 (2.45)*** | −14.82 (2.59) |
| Psoriasis | 53.83 (28.41) | 54.79 (29.97) | 51.01 (30.21) | 51.37 (27.55) | −25.33 (2.44)*** | −29.66 (2.44)*** | −23.44 (2.49)*** | −10.64 (2.62) |
| SF-36v2 PCS score | 35.35 (7.87) | 36.37 (7.58) | 35.94 (8.57) | 36.01 (7.43) | 5.51 (0.73)** | 5.69 (0.74)** | 6.23 (0.75)*** | 2.68 (0.79) |
| SF-36v2 MCS score | 40.78 (10.70) | 40.38 (11.97) | 42.80 (11.44) | 39.54 (10.55) | 4.35 (0.91) | 4.20 (0.91) | 3.13 (0.94) | 3.27 (0.98) |
| SF-36v2 norm-based domain scores | ||||||||
| PF | 34.45 (10.01) | 36.73 (9.53) | 36.55 (9.80) | 36.53 (9.09) | 5.17 (0.85)** | 5.23 (0.85)** | 5.22 (0.86)** | 2.06 (0.91) |
| RP | 37.38 (8.93) | 38.08 (9.20) | 37.94 (9.76) | 36.38 (8.71) | 4.45 (0.80) | 4.79 (0.80) | 5.21 (0.82) | 3.63 (0.86) |
| BP | 34.62 (7.44) | 34.91 (8.38) | 36.03 (7.88) | 35.10 (7.23) | 7.75 (0.84)*** | 8.05 (0.84)*** | 7.52 (0.86)*** | 3.77 (0.90) |
| GH | 35.94 (7.59) | 35.61 (8.51) | 35.54 (8.23) | 34.57 (7.92) | 4.09 (0.70) | 3.95 (0.70) | 4.73 (0.71)* | 2.64 (0.75) |
| VT | 41.75 (9.16) | 39.87 (9.92) | 42.80 (10.29) | 41.55 (8.86) | 5.50 (0.89)* | 5.90 (0.89)* | 4.93 (0.91) | 3.05 (0.95) |
| SF | 38.26 (10.30) | 39.55 (11.32) | 40.12 (10.61) | 37.97 (9.72) | 5.95 (0.90)* | 5.22 (0.90) | 5.26 (0.92) | 3.63 (0.96) |
| RE | 37.39 (11.33) | 39.04 (12.68) | 40.89 (12.50) | 35.67 (11.81) | 4.21 (1.01) | 4.82 (1.01) | 3.35 (1.04) | 3.68 (1.08) |
| MH | 38.68 (10.42) | 37.88 (11.50) | 39.57 (10.48) | 38.71 (10.32) | 4.45 (0.93) | 4.23 (0.93) | 3.95 (0.96) | 2.62 (1.01) |
| FACIT-Fatigue | ||||||||
| Total score | 28.0 (10.46) | 28.2 (10.63) | 30.0 (11.23) | 28.5 (9.52) | 7.0 (0.85)** | 6.0 (0.85)* | 6.0 (0.87)* | 3.3 (0.91) |
| Experience domain score | 8.9 (4.27) | 8.7 (4.42) | 9.7 (4.64) | 9.3 (3.98) | 3.3 (0.38)*** | 2.8 (0.38)* | 2.9 (0.39)** | 1.6 (0.41) |
| Impact domain score | 19.1 (6.66) | 19.5 (6.71) | 20.3 (6.96) | 19.3 (5.94) | 3.8 (0.52)** | 3.2 (0.52)* | 3.2 (0.53)* | 1.8 (0.56) |
| EQ-5D-3L dimension scores | ||||||||
| Mobility | 1.81 (0.42) | 1.71 (0.46) | 1.75 (0.44) | 1.77 (0.42) | −0.28 (0.05)** | −0.27 (0.05)** | −0.29 (0.05)** | −0.11 (0.05) |
| Self-care | 1.47 (0.50) | 1.49 (0.50) | 1.50 (0.50) | 1.49 (0.50) | −0.19 (0.05) | −0.11 (0.05) | −0.18 (0.05) | −0.12 (0.05) |
| Usual activities | 1.85 (0.45) | 1.80 (0.45) | 1.84 (0.46) | 1.87 (0.34) | −0.24 (0.05) | −0.29 (0.05) | −0.29 (0.05) | −0.17 (0.05) |
| Pain/discomfort | 2.20 (0.44) | 2.12 (0.49) | 2.10 (0.36) | 2.10 (0.33) | −0.25 (0.04)** | −0.27 (0.04)** | −0.28 (0.05)*** | −0.08 (0.05) |
| Anxiety/depression | 1.84 (0.52) | 1.82 (0.57) | 1.73 (0.56) | 1.79 (0.51) | −0.25 (0.06) | −0.17 (0.06) | −0.32 (0.06) | −0.21 (0.06) |
| EQ-VAS (mm) | 51.23 (21.62) | 52.67 (19.87) | 54.77 (19.57) | 50.76 (18.80) | 14.00 (2.10)** | 15.83 (2.09)*** | 13.10 (2.14)* | 6.37 (2.24) |
| ASQoL | 11.2 (5.00) | 10.5 (4.91) | 10.6 (5.26) | 10.4 (4.82) | −4.0 (0.45)** | −3.9 (0.46)** | −4.0 (0.46)** | −2.1 (0.49) |
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 questionnaire; 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 and Skin Assessment; PROs, patient-reported outcomes; PtGA, Patient Global Assessment of disease activity; RE, role emotional; RP, role physical; SF, social functioning; SF-36v2, Short Form-36 Health Survey version 2; VAS, visual analogue scale; VT, vitality.