Patient-reported outcomes in Adalimumab Effectiveness in Psoriatic Arthritis Trial: patients with clinically-important changes and complete resolution of functional limitations*
| Patient-reported outcome | Week 12 | Week 24 | ||||
|---|---|---|---|---|---|---|
| Placebo | Adalimumab | p Value† | Placebo | Adalimumab | p Value† | |
| DLQI, Dermatology Life Quality Index; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue Scale; HAQ DI, Health Assessment Questionnaire Disability Index; MCID, minimum clinically-important difference; PCS, physical component summary score; SF-36, Short-Form 36 Health Survey. | ||||||
| *Data based on observed intention-to-treat analysis. | ||||||
| †p Values are versus placebo based on Cochran–Mantel–Haenszel test. | ||||||
| HAQ DI | ||||||
| Patients achieving the MCID ⩾−0.3 points (%) | 26.0 | 51.4 | <0.001 | 26.9 | 52.5 | <0.001 |
| Patients with complete resolution (HAQ DI = 0) (%) | 14.3 | 33.8 | <0.001 | 13.1 | 34.0 | <0.001 |
| SF-36 PCS | ||||||
| Patients achieving the upper limit of the MCID ⩾5 points (%) | 26.5 | 66.9 | <0.001 | 30.1 | 61.7 | <0.001 |
| FACIT-Fatigue | ||||||
| Patients achieving the upper limit of the MCID ⩾4 points (%) | 30.4 | 60.7 | <0.001 | 31.5 | 61.9 | <0.001 |
| DLQI | ||||||
| Patients achieving the MCID⩾−5 points (%) | 21.7 | 54.8 | <0.001 | 23.7 | 55.0 | 0.001 |
| Patients with complete resolution (DLQI = 0) (%) | 4.9 | 36.9 | <0.001 | 5.0 | 43.6 | <0.001 |