PRO | Risankizumab (150 mg) | Placebo | |
LS mean change (95% CI) | LS mean change (95% CI) | Difference (95% CI) | |
FACIT-Fatigue* | n=224 4.9 (3.7 to 6.0) | n=219 2.6 (1.4 to 3.9) | 2.2 (0.6 to 3.9)† |
EQ-5D-5L index | n=197 0.09 (0.06 to 0.12) | n=165 0.01 (–0.02 to 0.04) | 0.08 (0.04 to 0.11)‡ |
EQ-5D-5L VAS | n=197 7.6 (4.8 to 10.3) | n=165 1.7 (–1.2 to 4.7) | 5.9 (1.9 to 9.8)† |
Pain VAS | n=197 –14.7 (–17.8 to –11.5) | n=165 –6.5 (–9.9 to –3.1) | –8.1 (–12.8 to –3.5)‡ |
PtGA VAS | n=197 –16.5 (–19.7 to –13.3) | n=165 –7.7 (–11.1 to –4.2) | –8.8 (–13.5 to –4.2)‡ |
*Multiplicity-adjusted results for ranked secondary endpoints were significant (p=0.009).
†Nominal p<0.01 for risankizumab versus placebo.
‡Nominal p<0.001 for risankizumab versus placebo.
EQ-5D-5L, EuroQoL-5 Dimension-5 Level; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue; LS, least squares; PRO, patient-reported outcome; PtGA, patient’s global assessment of disease activity; VAS, visual analogue scale.