PRO, LS mean change (95% CI) | BMI <25 kg/m2 | 25≤BMI<30 kg/m2 | BMI ≥30 kg/m2 | |||
Risankizumab (150 mg) | Placebo | Risankizumab (150 mg) | Placebo | Risankizumab (150 mg) | Placebo | |
SF-36 PCS | n=33 5.41 (2.96 to 7.87) | n=30 –0.44 (–2.98 to 2.11) | n=63 5.58 (3.88 to 7.29) | n=54 2.55 (0.73 to 4.38) | n=101 6.18 (4.69 to 7.67) | n=82 2.64 (1.05 to 4.24) |
SF-36 MCS | n=33 3.4 (0.6 to 6.2) | n=30 0.3 (–2.7 to 3.2) | n=63 2.5 (0.5 to 4.4) | n=54 1.4 (–0.7 to 3.5) | n=101 2.6 (1.0 to 4.1) | n=82 1.3 (–0.4 to 2.9) |
FACIT–Fatigue | n=33 3.8 (1.1 to 6.6) | n=30 –0.2 (–3.0 to 2.7) | n=63 4.1 (2.1 to 6.1) | n=54 3.0 (0.9 to 5.2) | n=101 5.7 (4.0 to 7.4) | n=82 3.1 (1.3 to 4.9) |
EQ–5D–5 L index | n=33 0.09 (0.04 to 0.15) | n=30 0.02 (–0.04 to 0.08) | n=63 0.07 (0.02 to 0.11) | n=53 –0.00 (–0.05 to 0.04) | n=101 0.10 (0.07 to 0.14) | n=82 0.02 (–0.02 to 0.06) |
EQ–5D–5 L VAS | n=33 7.7 (1.3 to 14.1) | n=30 –3.2 (–9.9 to 3.6) | n=63 5.1 (–0.0 to 10.3) | n=53 3.9 (–1.7 to 9.4) | n=101 8.9 (5.1 to 12.7) | n=82 1.8 (–2.3 to 5.9) |
Pain VAS | n=33 –13.0 (–20.6 to –5.4) | n=29 –0.1 (–8.1 to 7.9) | n=63 –10.5 (–16.5 to –4.6) | n=54 –9.7 (–16.1 to –3.3) | n=101 –17.6 (–22.0 to –13.2) | n=82 –6.2 (–10.9 to –1.5) |
PtGA VAS | n=33 –19.6 (–26.6 to –12.6) | n=29 –3.8 (–11.3 to 3.6) | n=63 –11.4 (–17.3 to –5.4) | n=54 –13.0 (–19.4 to –6.5) | n=101 –18.6 (–23.0 to –14.1) | n=82 –5.7 (–10.5 to –0.9) |
WPAI (0% to 100%) | ||||||
Overall work impairment | n=19 –17.0 (–27.6 to –6.4) | n=16 –1.9 (–13.6 to 9.7) | n=25 –9.7 (–19.5 to 0.2) | n=28 –1.3 (–10.6 to 8.1) | n=53 –14.5 (–22.5 to –6.6) | n=43 –4.4 (–13.0 to 4.1) |
Activity impairment | n=33 –14.9 (–22.0 to –7.8) | n=30 –1.9 (–9.3 to 5.6) | n=63 –11.5 (–17.7 to –5.2) | n=53 –5.8 (–12.6 to 0.9) | n=101 –13.8 (–18.5 to –9.2) | n=82 –6.5 (–11.5 to –1.5) |
Absenteeism* | n=19 –0.4 (–9.2 to 8.5) | n=16 5.5 (–4.3 to 15.2) | n=25 1.0 (–5.5 to 7.6) | n=28 2.9 (–3.4 to 9.2) | n=53 –3.3 (–10.2 to 3.7) | n=43 0.8 (–6.8 to 8.5) |
Presenteeism* | n=19 –18.7 (–27.3 to –10.1) | n=15 –8.0 (–17.7 to 1.7) | n=25 –10.1 (–18.8 to –1.3) | n=27 –1.5 (–10.0 to 7.0) | n=49 –13.8 (–20.2 to –7.3) | n=40 –4.4 (–11.1 to 2.4) |
*Reported only for patients who were employed.
bDMARD, biologic disease-modifying antirheumatic drug; BMI, body mass index; EQ-5D-5L, EuroQoL-5 Dimension-5 Level; FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy—Fatigue; IR, inadequate responder; 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.