Least squares mean change from baseline among patients who were csDMARD-IR (bDMARD-naïve) or bDMARD-IR at 24 weeks
| PRO, LS mean change (95% CI) | csDMARD-IR (bDMARD-naïve) | bDMARD-IR | ||||
| Risankizumab (150 mg) | Placebo | Difference (95% CI) | Risankizumab (150 mg) | Placebo | Difference (95% CI) | |
| SF-36 PCS | n=106 6.09 (4.66 to 7.52) | n=96 3.04 (1.58 to 4.50) | 3.05 (1.07 to 5.03)* | n=91 5.58 (4.14 to 7.03) | n=70 0.51 (–1.08 to 2.10) | 5.07 (2.93 to 7.21)† |
| SF-36 MCS | n=106 3.7 (2.2 to 5.3) | n=96 2.2 (0.6 to 3.8) | 1.5 (–0.7 to 3.7) | n=91 1.6 (0.03 to 3.2) | n=70 0.1 (–1.6 to 1.9) | 1.45 (–0.87 to 3.77) |
| FACIT-Fatigue | n=106 5.8 (4.2 to 7.4) | n=96 4.1 (2.4 to 5.8) | 1.7 (–0.6 to 4.0) | n=91 4.1 (2.4 to 5.8) | n=70 1.0 (–0.8 to 2.9) | 3.1 (0.6 to 5.6)* |
| EQ-5D-5L index | n=106 0.08 (0.04 to 0.11) | n=95 0.04 (0.00 to 0.07) | 0.04 (–0.01 to 0.09) | n=91 0.10 (0.07 to 0.14) | n=70 –0.02 (–0.07 to 0.02) | 0.13 (0.07 to 0.18)† |
| EQ-5D-5L VAS | n=106 6.4 (2.6 to 10.1) | n=95 5.9 (2.0 to 9.8) | 0.4 (–4.9 to 5.7) | n=91 9.1 (5.1 to 13.1) | n=70 –3.8 (–8.2 to 0.7) | 12.9 (6.9 to 18.8)† |
| Pain VAS | n=106 –16.6 (–21.1 to –12.0) | n=95 –9.6 (–14.3 to –4.9) | –7.0 (–13.4 to –0.6)* | n=91 –13.1 (–17.6 to –8.6) | n=70 –3.1 (–8.1 to 1.9) | –10.0 (–16.7 to –3.2)* |
| PtGA VAS | n=106 –19.1 (–23.5 to –14.8) | n=95 –12.9 (–17.4 to –8.4) | –6.2 (–12.4 to –0.1)* | n=91 –13.8 (–18.6 to –9.0) | n=70 –1.1 (–6.5 to 4.2) | –12.7 (–19.8 to –5.5)† |
| WPAI (0% to 100%) | ||||||
| Overall work impairment‡ | n=54 –12.9 (–19.9 to –6.0) | n=48 –6.2 (–13.4 to 1.1) | –6.8 (–16.5 to 3.0) | n=43 –15.4 (–23.8 to –7.1) | n=39 –0.9 (–9.6 to 7.8) | –14.5 (–26.5 to –2.5)* |
| Activity impairment | n=106 –13.7 (–18.4 to –8.9) | n=95 –7.6 (–12.6 to –2.7) | –6.0 (–12.7 to 0.6) | n=91 –12.6 (–17.2 to –8.1) | n=70 –2.1 (–7.1 to 3.0) | –10.6 (–17.3 to –3.8)* |
| Absenteeism‡ | n=54 –2.2 (–7.4 to 3.0) | n=48 1.2 (–4.4 to 6.7) | –3.4 (–10.8 to 4.1) | n=43 –2.4 (–10.3 to 5.4) | n=39 3.2 (–5.1 to 11.4) | –5.6 (–16.9 to 5.8) |
| Presenteeism‡ | n=52 –12.1 (–18.0 to –6.2) | n=46 –6.7 (–12.9 to –0.5) | –5.4 (–13.7 to 2.9) | n=41 –15.7 (–22.7 to –8.8) | n=36 –1.4 (–8.8 to 5.9) | –14.3 (–24.4 to –4.3)† |
*Nominal p<0.05 for risankizumab versus placebo.
†Nominal p<0.001 for risankizumab versus placebo.
‡Reported only for patients who were employed.
bDMARD, biologic disease-modifying antirheumatic drug; csDMARD, conventional synthetic disease-modifying antirheumatic drug; EQ-5D-5L, EuroQoL-5 Dimension-5 Level; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue; IR, inadequate responder; LS, least squares; MCS, mental component summary; PCS, physical component summary; PRO, patient-reported outcome; PtGA, patient’s global assessment of disease activity; SF-36, 36-Item Short-Form Health Survey; VAS, visual analogue scale; WPAI, Work Productivity and Activity Impairment.