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-DI1.26 (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 psoriasis65.37 (21.31)68.16 (21.31)62.85 (24.38)−26.35 (2.17)***−28.22 (2.22)***−10.56 (2.21)
 Arthritis66.62 (20.61)67.88 (22.41)62.65 (24.62)−25.11 (2.25)***−26.69 (2.29)***−11.48 (2.29)
 Psoriasis53.50 (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 score33.57 (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 score39.76 (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
 PF33.45 (10.43)32.12 (9.87)34.03 (10.99)5.00 (0.72)**4.08 (0.73)*1.69 (0.73)
 RP34.63 (10.34)32.69 (9.25)35.86 (10.69)4.99 (0.81)5.44 (0.81)*2.85 (0.81)
 BP33.24 (7.88)32.63 (6.94)35.42 (8.73)7.00 (0.79)***7.59 (0.80)***2.10 (0.80)
 GH34.71 (8.71)33.53 (9.29)35.60 (10.09)3.67 (0.64)3.92 (0.65)2.45 (0.65)
 VT39.70 (10.22)38.51 (9.02)40.25 (10.73)4.95 (0.83)*4.75 (0.84)*2.41 (0.84)
 SF36.46 (11.47)35.26 (11.12)37.56 (11.81)6.25 (0.84)**5.46 (0.86)*2.89 (0.86)
 RE35.50 (13.95)35.49 (13.49)36.03 (14.12)5.44 (1.00)4.84 (1.00)3.85 (1.00)
 MH38.33 (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 score26.1 (12.15)26.1 (10.27)27.5 (11.58)7.0 (0.81)***5.8 (0.82)*3.0 (0.82)
 Experience domain score8.2 (5.07)8.1 (4.29)8.6 (4.80)3.1 (0.38)**2.6 (0.39)*1.5 (0.39)
 Impact domain score17.8 (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
 Mobility1.68 (0.47)1.78 (0.42)1.71 (0.46)−0.17 (0.04)*−0.15 (0.04)−0.05 (0.04)
 Self-care1.46 (0.50)1.61 (0.49)1.50 (0.56)−0.15 (0.04)−0.15 (0.04)−0.04 (0.04)
 Usual activities1.91 (0.46)1.98 (0.43)1.92 (0.49)−0.23 (0.04)−0.22 (0.04)−0.15 (0.04)
 Pain/discomfort2.24 (0.46)2.27 (0.46)2.21 (0.46)−0.32 (0.04)**−0.29 (0.04)**−0.12 (0.04)
 Anxiety/depression1.69 (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)
ASQoL11.4 (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.