Table 3.
LSM change from baseline to week 12/14 in PRO scores
| PRO measures, LSM change (95% CI) | MTX-naïve change from baseline to Week 12 |
MTX-IR change from baseline to Week 14 |
||||
|---|---|---|---|---|---|---|
| MTX (n = 314) | UPA 15 mg (n = 317) | UPA 30 mg (n = 314) | MTX (n = 216) | UPA 15 mg (n = 217) | UPA 30 mg (n = 215) | |
| PtGA (mm) | −24.59 (−27.48, −21.71) | −34.90* (−37.66, −32.14) | −38.00* (−40.80, −35.19) | −11.18 (−14.85, −7.50) | −23.40* (−27.05, −19.75) | −29.89* (−33.52, −26.26) |
| Pain VAS (mm) | −25.36 (−28.28, −22.44) | −36.28* (−39.08, −33.49) | −39.67* (−42.51, −36.84) | −13.88 (−17.44, −10.31) | −26.15* (−29.69, −22.60) | −33.18* (−36.70, −29.66) |
| HAQ-DI | −0.51 (−0.58, −0.44) | −0.84* (−0.91, −0.77) | −0.86* (−0.93, −0.79) | −0.32 (−0.41, −0.24) | −0.65* (−0.73, −0.57) | −0.73* (−0.81, −0.64) |
| FACIT-F | 6.80 (5.70, 7.91) | 10.01* (8.94, 11.07) | 9.57* (8.50, 10.64) | – | – | – |
| AM stiffness | ||||||
| Duration (min) | −72.37 (−83.67, −61.06) | −105.97*(−116.87, −95.08) | −111.52*(−122.49, −100.56) | −53.03 (−72.18, −33.88) | −94.56*(−113.57, −75.54) | −102.34*(−121.24, −83.45) |
| Severitya | −3.02 (−3.31, −2.73) | −3.95* (−4.23, −3.67) | −4.05* (−4.33, −3.76) | −1.56 (−1.91, −1.22) | −3.08* (−3.43, −2.74) | −3.55* (−3.90, −3.21) |
| SF-36 summary scores | ||||||
| PCS | 5.77 (4.83, 6.71) | 10.09* (9.19, 10.99) | 10.11* (9.20, 11.01) | 4.32 (3.19, 5.44) | 8.28* (7.17, 9.40) | 10.19* (9.07, 11.30) |
| MCS | 3.86 (2.81, 4.92) | 5.79* (4.78, 6.80) | 5.78* (4.76, 6.80) | 1.88 (0.64, 3.12) | 4.55* (3.33, 5.78) | 4.68*(3.46, 5.91) |
| SF-36 domains | ||||||
| PF | 5.61 (4.56, 6.65) | 10.04* (9.03, 11.04) | 10.05* (9.04, 11.06) | 4.11 (2.90, 5.32) | 8.47* (7.27, 9.67) | 10.27*(9.08, 11.47) |
| RP | 4.67 (3.68, 5.66) | 8.43* (7.48, 9.38) | 8.57* (7.62, 9.52) | 3.58 (2.46, 4.71) | 7.02* (5.91, 8.13) | 8.26*(7.15, 9.37) |
| BP | 7.41 (6.42, 8.39) | 11.87* (10.92, 12.82) | 11.94* (10.99, 12.89) | 4.67 (3.47, 5.87) | 8.89* (7.70, 10.07) | 11.02*(9.84, 12.20) |
| GH | 4.43 (3.49, 5.37) | 6.33* (5.43, 7.23) | 6.83* (5.93, 7.74) | 2.81 (1.68, 3.94) | 5.57*(4.45, 6.69) | 7.05*(5.93, 8.17) |
| VT | 5.54 (4.51, 6.57) | 9.33* (8.33, 10.32) | 8.64* (7.65, 9.64) | 3.13 (1.85, 4.40) | 8.06* (6.80, 9.32) | 8.36*(7.10, 9.61) |
| SF | 4.62 (3.52, 5.71) | 7.66* (6.62, 8.71) | 8.14* (7.09, 9.19) | 3.56 (2.28, 4.83) | 6.26* (5.01, 7.52) | 7.01*(5.76, 8.26) |
| RE | 4.21 (3.11, 5.32) | 6.39* (5.33, 7.44) | 6.81* (5.75, 7.87) | 2.05 (0.79, 3.31) | 4.82* (3.57, 6.06) | 6.08* (4.83, 7.32) |
| MH | 4.56 (3.49, 5.62) | 6.93* (5.91, 7.94) | 6.77* (5.75, 7.79) | 2.46 (1.21, 3.72) | 5.35* (4.11, 6.58) | 5.67*(4.43, 6.90) |
| SF-6D health utility index score | 0.07 (0.06, 0.09) | 0.13*(0.11, 0.14) | 0.12*(0.11, 0.14) | 0.05 (0.04, 0.07) | 0.10* (0.08, 0.11) | 0.11* (0.10, 0.13) |
| WPAI activity impairment | −18.95 (−21.93, −15.98) | −27.64* (−30.49, −24.79) | −31.21* (−34.08, −28.34) | – | – | – |
| WPAI overall work impairmentb | −9.81 (−15.27, −4.35) | −26.61* (−31.62, −21.59) | −23.52* (−28.91, −18.14) | – | – | – |
Assessed on a numeric scale of 1–10 with 10 indicating the worst level.
Calculated only for employed subjects.
P < 0.01 for UPA vs MTX.
AM, morning; BP, bodily pain; FACIT-F, 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; MTX-IR, inadequate response to MTX; PCS, Physical Component Summary; PF, physical functioning; PRO, patient-reported outcome; PtGA, Patient’s Global Assessment of Disease Activity; RE, role-emotional; RP, role-physical; SF, social functioning; SF-36, 36-Item Short Form Health Survey; UPA, upadacitinib; VAS, visual analogue scale; VT, vitality; WPAI, Work Productivity and Activity Impairment Questionnaire.