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-DI1.16 (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 psoriasis61.99 (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)
 Arthritis64.77 (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)
 Psoriasis53.83 (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 score35.35 (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 score40.78 (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
 PF34.45 (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)
 RP37.38 (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)
 BP34.62 (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)
 GH35.94 (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)
 VT41.75 (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)
 SF38.26 (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)
 RE37.39 (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)
 MH38.68 (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 score28.0 (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 score8.9 (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 score19.1 (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
 Mobility1.81 (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-care1.47 (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 activities1.85 (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/discomfort2.20 (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/depression1.84 (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)
ASQoL11.2 (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.