PROs at baseline and LSM changes from baseline at months 3, 6, 12 and 24
| PRO | Baseline mean (SD) | Month 3 LSM change from baseline (SE) | Month 6 LSM change from baseline (SE) | Month 12 LSM change from baseline (SE) | Month 24 LSM change from baseline (SE) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tofacitinib 5 mg two times per day N=370 | Tofacitinib 10 mg two times per day N=393 | MTX N=184 | Tofacitinib 5 mg two times per day N=351 | Tofacitinib 10 mg two times per day N=380 | MTX N=169 | Tofacitinib 5 mg two times per day N=337 | Tofacitinib 10 mg two times per day N=363 | MTX N=156 | Tofacitinib 5 mg two times per day N=312 | Tofacitinib 10 mg two times per day N=328 | MTX N=133 | Tofacitinib 5 mg two times per day N=261 | Tofacitinib 10 mg two times per day N=278 | MTX N=105 | |
| Patient Global Assessment | 60.42 (24.49) | 60.88 (22.55)a | 57.91 (24.33) | –30.12 (1.19)b** | –31.79 (1.13)c*** | –22.63 (1.67) | –31.86 (1.20)d* | –35.10 (1.15)e** | –27.67 (1.71) | –32.94 (1.23)f* | –34.63 (1.19)g*** | –26.18 (1.80) | –34.41 (1.29)h* | –35.79 (1.24)i* | –28.95 (1.94) |
| Pain | 59.23 (23.86) | 61.38 (23.06)a | 59.00 (23.61) | –30.04 (1.19)b** | –33.01 (1.13)c*** | –22.77 (1.67)j | –32.11 (1.20)k | –35.35 (1.15)e** | –28.34 (1.71) | –32.46 (1.23)l* | –35.85 (1.19)m** | –27.98 (1.80) | –34.79 (1.29)* | –37.62 (1.25)i** | –29.67 (1.94) |
| HAQ-DI | 1.54 (0.64) | 1.50 (0.67) | 1.53 (0.65) | –0.76 (0.03)*** | –0.86 (0.03)c*** | –0.48 (0.04) | –0.84 (0.03)*** | –0.94 (0.03)e*** | –0.59 (0.04) | –0.88 (0.03)** | –0.98 (0.03)m*** | –0.69 (0.04) | –0.91 (0.03)** | –1.02 (0.03)*** | –0.71 (0.05) |
| SF-36 | |||||||||||||||
| PCS | 32.82 (7.25) | 33.19 (7.33)n | 33.51 (7.83)o | 9.26 (0.43)*** | 10.34 (0.42)p*** | 5.06 (0.61) | 9.74 (0.44)*** | 11.26 (0.42)e*** | 6.66 (0.62)q | 10.34 (0.45)** | 12.37 (0.43)m*** | 7.55 (0.65)r | 11.14 (0.46)*** | 12.49 (0.45)*** | 7.72 (0.69) |
| MCS | 40.47 (12.05) | 40.69 (11.76)n | 40.86 (11.30)o | 6.19 (0.51)* | 5.85 (0.49)p | 4.33 (0.72) | 6.43 (0.52) | 6.49 (0.50)e | 4.92 (0.74)q | 6.27 (0.53) | 6.60 (0.51)m* | 4.69 (0.77)r | 6.20 (0.55) | 7.44 (0.53) | 5.59 (0.83) |
| SF-36 domain | |||||||||||||||
| PF | 30.13 (9.44) | 31.58 (9.88) | 32.04 (9.59) | 9.17 (0.52)*** | 10.16 (0.50)c*** | 4.33 (0.73)j | 9.73 (0.53)*** | 11.37 (0.51)*** | 5.75 (0.75) | 10.68 (0.54)** | 12.71 (0.52)m*** | 7.37 (0.78) | 11.74 (0.56)** | 13.04 (0.54)*** | 7.92 (0.83) |
| RP | 33.43 (9.58) | 34.10 (9.37) | 33.88 (9.39) | 8.86 (0.49)*** | 9.81 (0.46)c*** | 5.27 (0.68)j | 9.70 (0.49)** | 10.64 (0.47)*** | 6.68 (0.69) | 9.86 (0.50)* | 11.74 (0.48)*** | 7.10 (0.72) | 10.41 (0.52)* | 12.26 (0.50)*** | 7.84 (0.77) |
| BP | 33.19 (8.04) | 33.23 (7.22) | 33.77 (7.57)o | 10.72 (0.48)*** | 11.50 (0.46)c*** | 6.89 (0.68) | 11.00 (0.49)* | 12.59 (0.47)*** | 8.46 (0.70)q | 11.70 (0.50)** | 13.35 (0.48)*** | 8.54 (0.73)r | 12.18 (0.53)* | 13.80 (0.51)*** | 9.19 (0.79) |
| GH | 37.96 (9.01) | 37.20 (8.56) | 37.51 (8.56) | 6.08 (0.41)* | 6.45 (0.40)c** | 3.95 (0.58)j | 6.19 (0.42) | 6.81 (0.40)* | 4.99 (0.59) | 6.12 (0.43) | 7.21 (0.41)* | 5.36 (0.62) | 6.49 (0.44)* | 7.41 (0.43)** | 4.88 (0.66) |
| VT | 41.79 (9.89) | 41.55 (9.96)n | 41.62 (9.49) | 8.20 (0.50)** | 8.84 (0.48)p*** | 5.06 (0.70)j | 8.41 (0.50)* | 8.64 (0.48)e* | 6.01 (0.71) | 8.40 (0.51)* | 9.37 (0.50)* | 6.50 (0.75) | 8.23 (0.54) | 9.33 (0.52)* | 6.62 (0.79) |
| SF | 36.38 (11.35) | 36.67 (11.10) | 37.52 (11.33) | 8.14 (0.51)** | 7.86 (0.48)c* | 5.22 (0.71)j | 8.50 (0.51) | 9.20 (0.49)* | 6.99 (0.73) | 8.54 (0.52)* | 9.59 (0.50)*** | 5.87 (0.76) | 9.09 (0.55)* | 10.40 (0.53)** | 6.94 (0.82) |
| RE | 33.98 (13.36) | 34.73 (13.09) | 34.67 (12.61) | 7.26 (0.57)* | 7.64 (0.54)c** | 4.35 (0.80)j | 7.60 (0.57) | 9.09 (0.55) ** | 5.70 (0.82) | 7.65 (0.58) | 9.30 (0.56)** | 5.93 (0.85) | 8.64 (0.61) | 10.41 (0.59)** | 6.62 (0.92) |
| MH | 38.85 (11.92) | 39.42 (11.77)n | 39.72 (11.35) | 6.64 (0.53)* | 6.35 (0.50)p | 4.66 (0.74)j | 7.08 (0.53)* | 6.79 (0.51)e* | 4.63 (0.76) | 7.31 (0.54)* | 7.33 (0.52)* | 5.28 (0.79) | 6.81 (0.57) | 8.02 (0.55) | 6.38 (0.85) |
| FACIT-F | 28.43 (10.94) | 29.01 (10.73) | 28.49 (10.57)o | 8.19 (0.48)s** | 8.72 (0.46)c*** | 5.33 (0.67)t | 8.83 (0.48)* | 9.13 (0.46)e** | 6.45 (0.69) | 8.85 (0.49)* | 9.17 (0.48)g* | 6.91 (0.71) | 8.94 (0.51)* | 9.56 (0.49)i** | 6.32 (0.76) |
| MOS-Sleep | 42.68 (19.55)u | 42.86 (20.56)a | 42.99 (18.09) | –12.60 (0.88)s* | –11.12 (0.83)c | –9.11 (1.22)j | –11.76 (0.88)k | –12.28 (0.84) | –9.83 (1.25) | –12.34 (0.90)l* | –11.94 (0.87)m | –9.20 (1.31) | –11.57 (0.94) | –11.80 (0.91)v | –10.84 (1.40) |
Baseline data and LSM change from baseline data at months 6, 12 and 24 for HAQ-DI, and significance versus MTX, were reported previously21 and are presented here for comparison. Baseline values are descriptive; LSM change from baseline data are FAS, longitudinal model.
*p<0.05; **p<0.001; ***p<0.0001 vs MTX.
aN=394; bN=348; cN=379; dN=335; eN=362; fN=310; gN=326; hN=260; iN=277; jN=170; kN=336; lN=311; mN=327; nN=392; oN=183; pN=378; qN=155; rN=132; sN=349; tN=168; uN=369; vN=276.
BP, Bodily Pain; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; FAS, full analysis set; GH, General Health; HAQ-DI, Health Assessment Questionnaire-Disability Index; LSM, least squares mean; MCS, Mental Component Score; MH, Mental Health; MOS, Medical Outcomes Study; MTX, methotrexate; Pain, Patient Assessment of Arthritis Pain; PCS, Physical Component Score; PF, Physical Functioning; PROs, patient-reported outcomes; RE, Role Emotional; RP, Role Physical; SF, Social Functioning; SF-36, Short Form-36; VT, Vitality.