Table 2.
PROs at week 2
| PRO measures | MTX-naïve |
MTX-IR |
||||
|---|---|---|---|---|---|---|
| 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) | |
| LSM change from baseline (95% CI) | ||||||
| PtGA (mm) | −8.59 (−11.10, −6.07) | −20.02*(−22.51, −17.53) | −25.39*(−27.91, −22.87) | −4.60 (−7.71, −1.49) | −13.93*(−17.02, −10.85) | −16.76*(−19.82, −13.69) |
| Pain VAS (mm) | −8.71 (−11.26, −6.16) | −19.71*(−22.23, −17.18) | −24.38*(−26.93, −21.83) | −4.74 (−7.67, −1.81) | −14.37*(−17.28, −11.47) | −19.52*(−22.41, −16.63) |
| HAQ-DI | −0.19 (−0.25, −0.14) | −0.44*(−0.50, −0.39) | −0.50*(−0.55, −0.44) | −0.16 (−0.22, −0.09) | −0.34*(−0.41, −0.28) | −0.43*(−0.50, −0.37) |
| AM stiffness | ||||||
| Duration (min) | −10.00 (−25.66, −5.65) | −42.20*(−57.66, −26.74) | −74.57*(−90.16, −58.98) | −12.84 (−31.71, 6.04) | −59.78*(−78.43, −41.12) | −51.13*(−69.80, −32.47) |
| Severitya | −1.01 (−1.26, −0.76) | −1.99*(−2.24, −1.75) | −2.46*(−2.70, −2.21) | −0.82 (−1.11, −0.54) | −1.52*(−1.80, −1.23) | −1.86*(−2.14, −1.58) |
| Patients reporting improvements greater than or equal to the MCID, n (%) | ||||||
| PtGA (mm) | 134 (42.7) | 186 (58.7)* | 190 (61.1)* | 71 (32.9) | 111 (51.4)* | 127 (59.1)* |
| Pain VAS (mm) | 129 (41.1) | 198 (62.5)* | 202 (65.0)* | 68 (31.5) | 117 (54.2)* | 141 (65.6)* |
| HAQ-DI | 132 (42.0) | 203 (64.0)* | 201 (64.6)* | 77 (35.6) | 114 (52.8)* | 125 (58.1*) |
| AM stiffness | ||||||
| Duration (min) | 27 (8.6) | 60 (19.0)* | 65 (20.8)* | 18 (8.4) | 34 (15.7)** | 30 (14.0) |
| Severitya | 162 (51.8) | 235 (74.4)* | 231 (73.8)* | 104 (48.4) | 128 (59.0)** | 147 (68.7)* |
a
Assessed on a numeric scale of 1–10 with 10 indicating the worst level.
*
P < 0.01 for UPA vs MTX,.
**
P < 0.05 for UPA vs MTX.
AM, morning; HAQ-DI, Health Assessment Questionnaire Disability Index; LSM, least squares mean; MCID, minimum clinically important difference; MTX-IR, inadequate response to MTX; PRO, patient-reported outcome; PtGA, Patient’s Global Assessment of Disease Activity; UPA, upadacitinib; VAS, visual analogue scale.