Table 1.
Continuous efficacy endpoints at week 56 (MMRM based on as observed data)
| Parameter | Placebo → UPA 15 mg QD (N=211) | Placebo → UPA 30 mg QD (N=212) | UPA 15 mg QD (N=429) | UPA 30 mg QD (N=423) | ADA 40 mg EOW (N=429) | |||||
| N | LSM change from BL (95% CI) | N | LSM change from BL (95% CI) | N | LSM change from BL (95% CI) | N | LSM change from BL (95% CI) | N | LSM change from BL (95% CI) | |
| PhGA | 177 | −4.7 (−4.9 to −4.5) | 177 | −4.8 (−5.1 to −4.6) | 378 | −4.9 (−5.0 to −4.7) | 360 | −4.9 (−5.0 to −4.7) | 360 | −4.7 (−4.8 to −4.5) |
| Swollen Joint Count (66 joints) | 178 | −9.2 (−9.7 to −8.7) | 178 | −9.6 (−10.1 to −9.2) | 375 | −9.7 (−10.1 to −9.4) | 360 | −9.8 (−10.1 to −9.4) | 358 | −9.6 (−9.9 to −9.3) |
| Tender Joint Count (68 joints) | 178 | −15.4 (−16.4 to −14.3) | 178 | −15.6 (−16.7 to −14.6) | 375 | −15.7 (−16.4 to −14.9) | 360 | −15.8 (−16.5 to −15.0) | 358 | −15.3 (−16.1 to −14.6) |
| C-reactive protein, mg/L | 173 | −7.5 (−8.6 to −6.5) | 169 | −8.7 (−9.8 to −7.7) | 356 | −7.8 (−8.6 to −7.1) | 351 | −8.6 (−9.3 to −7.9)† | 353 | −7.5 (−8.2 to −6.7) |
| HAQ-DI | 178 | −0.40 (−0.48 to −0.32) | 176 | −0.45 (−0.53 to −0.38) | 370 | −0.54 (−0.59 to −0.48)* | 361 | −0.56 (−0.61 to −0.50)† | 361 | −0.43 (−0.49 to −0.38) |
| FACIT-F | 178 | 7.2 (5.9 to 8.6) | 176 | 8.8 (7.4 to 10.1) | 370 | 8.9 (8.0 to 9.9) | 362 | 8.4 (7.4 to 9.4) | 364 | 7.6 (6.7 to 8.6) |
| SF-36 PCS | 178 | 9.3 (8.0 to 10.5) | 176 | 9.8 (8.6 to 11.1) | 371 | 10.8 (10.0 to 11.7)* | 362 | 10.5 (9.6 to 11.4)† | 364 | 8.9 (8.0 to 9.8) |
| SF-36 MCS | 178 | 3.6 (2.3 to 4.9) | 176 | 4.0 (2.7 to 5.3) | 371 | 5.2 (4.2 to 6.1) | 362 | 4.4 (3.4 to 5.3) | 364 | 4.3 (3.4 to 5.2) |
| Self-Assessment of Psoriasis Symptoms | 178 | −28.1 (−30.5 to −25.6) | 175 | −30.3 (−32.8 to −27.9) | 370 | −29.6 (−31.4 to −27.9)* | 362 | −30.4 (−32.2 to −28.7)† | 364 | −25.8 (−27.6 to −24.1) |
| WPAI overall work impairment‡ | 88 | −21.9 (−27.1 to −16.7) | 85 | −24.7 (−30.0 to −19.5) | 187 | −24.5 (−28.1 to −20.9) | 190 | −22.9 (−26.5 to −19.3) | 180 | −20.8 (−24.5 to −17.1) |
| PtGA (NRS) | 178 | −3.4 (−3.7 to −3.0) | 176 | −3.7 (−4.0 to −3.3) | 370 | −3.7 (−3.9 to −3.4)* | 361 | −3.6 (−3.9 to −3.4)† | 362 | −3.2 (−3.4 to −2.9) |
| Patients’ assessment of pain (NRS) | 178 | −3.1 (−3.5 to −2.8) | 176 | −3.3 (−3.7 to −3.0) | 370 | −3.3 (−3.6 to −3.1)* | 361 | −3.3 (−3.6 to −3.1)† | 362 | −2.9 (−3.1 to −2.7) |
| DAPSA | 173 | −38.9 (−41.1 to −36.7) | 166 | −41.6 (−43.8 to −39.3) | 355 | −40.0 (−41.5 to −38.4) | 348 | −41.0 (−42.6 to −39.4)† | 350 | −38.5 (−40.1 to −36.9) |
| ASDAS§ | 62 | −1.7 (−1.9 to −1.4) | 44 | −1.9 (−2.2 to −1.6) | 113 | −1.8 (−2.0 to −1.6) | 113 | −1.9 (−2.1 to −1.7)† | 102 | −1.6 (−1.8 to −1.4) |
| BASDAI§ | 63 | −3.1 (−3.6 to −2.6) | 46 | −3.1 (−3.7 to −2.5) | 116 | −3.3 (−3.7 to −2.9) | 119 | −3.2 (−3.6 to −2.8) | 107 | −2.8 (−3.2 to −2.4) |
All p values are nominal. Analyses were conducted using an MMRM model based on as observed data. Missing data were handled by MMRM assuming missing at random.
Per study design, all patients in the placebo group were switched to upadacitinib 15 mg one time a day or upadacitinib 30 mg one time a day at week 24.
*P≤0.05; for upadacitinib 15 mg QD versus adalimumab.
†P≤0.05; for upadacitinib 30 mg QD versus adalimumab.
‡Assessed in patients employed at baseline.
§Assessed in patients with psoriatic spondylitis at baseline as determined by the investigator based on available information, which could have included previous imaging, the duration and characteristics of the back pain and the age of onset.
ADA, adalimumab; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BL, baseline; DAPSA, Disease Activity in Psoriatic Arthritis; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; LSM, least squares mean; MCS, Mental Component Summary; MMRM, mixed-effects model repeated measures; NRS, numeric rating scale; PCS, Physical Component Summary; PhGA, Physicians’ Global Assessment of Disease Activity; PtGA, Patients' Global Assessment of Disease Activity; SF-36, Short Form Health Survey questionnaire; UPA, upadacitinib; WPAI, Work Productivity and Activity Impairment.