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PRO*
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Mean scores (95% CI) corresponding to PASDAS cutoffs for disease activity
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Mean scores (95% CI) corresponding to MDA
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Very low: 1.9
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Low: 3.2
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High: 5.4
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5 points
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EQ-5D-3L VAS
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OPAL Broaden
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78.2 (76.6, 79.8)
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69.5 (68.2, 70.7)
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54.7 (53.4, 56.0)
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74.6 (73.0, 76.2)
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OPAL Beyond
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78.9 (76.7, 81.1)
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69.9 (68.2, 71.6)
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54.7 (53.2, 56.1)
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75.5 (73.2, 77.9)
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EQ-5D-3L UI
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OPAL Broaden
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0.8 (0.8, 0.8)
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0.7 (0.7, 0.7)
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0.5 (0.5, 0.6)
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0.8 (0.7, 0.8)
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OPAL Beyond
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0.8 (0.8, 0.8)
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0.7 (0.7, 0.7)
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0.5 (0.5, 0.5)
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0.8 (0.7, 0.8)
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FACIT-F total score
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OPAL Broaden
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40.1 (39.2, 41.0)
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36.4 (35.6, 37.2)
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30.2 (29.4, 31.0)
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38.2 (37.3, 39.1)
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OPAL Beyond
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40.6 (39.5, 41.7)
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36.3 (35.3, 37.2)
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29.0 (28.1, 29.8)
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39.2 (38.0, 40.4)
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FACIT-F ED
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OPAL Broaden
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14.3 (14.0, 14.7)
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12.7 (12.3, 13.0)
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9.9 (9.6, 10.2)
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13.4 (13.0, 13.8)
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OPAL Beyond
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14.4 (13.9, 15.0)
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12.6 (12.2, 13.0)
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9.4 (9.0, 9.8)
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13.9 (13.4, 14.4)
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FACIT-F ID
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OPAL Broaden
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25.8 (25.2, 26.3)
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23.7 (23.2, 24.2)
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20.3 (19.8, 20.8)
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24.9 (24.3, 25.4)
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OPAL Beyond
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26.2 (25.5, 26.9)
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23.7 (23.1, 24.3)
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19.6 (19.0, 20.1)
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25.4 (24.7, 26.1)
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PGJS-VAS, mm
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OPAL Broaden
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12.6 (11.1, 14.0)
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28.2 (27.1, 29.3)
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54.7 (53.6, 55.8)
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22.1 (20.4, 23.7)
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OPAL Beyond
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11.4 (9.5, 13.3)
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27.8 (26.3, 29.2)
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55.4 (54.1, 56.7)
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20.2 (17.7, 22.7)
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PGJS-VAS-PsO, mm
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OPAL Broaden
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11.0 (9.1, 12.9)
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24.0 (22.4, 25.5)
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45.9 (44.2, 47.5)
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18.7 (16.7, 20.6)
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OPAL Beyond
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8.6 (6.0, 11.2)
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22.2 (20.2, 24.2)
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45.2 (43.3, 47.0)
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16.5 (13.6, 19.5)
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SF-36v2 PCS
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OPAL Broaden
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NA
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NA
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NA
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45.2 (44.5, 45.8)
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OPAL Beyond
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NA
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NA
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NA
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44.6 (43.7, 45.5)
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SF-36v2 PF
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OPAL Broaden
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NA
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NA
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NA
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45.3 (44.5, 46.1)
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OPAL Beyond
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NA
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NA
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NA
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43.4 (42.3, 44.5)
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Pain VAS
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OPAL Broaden
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13.4 (11.8, 15.0)
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26.3 (25.0, 27.5)
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48.0 (46.7, 49.4)
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NA
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OPAL Beyond
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11.5 (9.3, 13.8)
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25.4 (23.7, 27.1)
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48.8 (47.4, 50.3)
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NA
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HAQ-DI
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OPAL Broaden
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0.5 (0.4, 0.5)
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0.7 (0.6, 0.7)
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1.0 (1.0, 1.0)
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NA
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OPAL Beyond
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0.5 (0.4, 0.6)
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0.7 (0.7, 0.8)
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1.2 (1.1, 1.2)
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NA
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- SF-36v2 PCS: norm-based scores were used (a score of 50 representing the mean for the general population, with higher scores indicating less impairment); ScoreMDA: continuous MDA with values from 0 to 7 (0–4, no MDA; 5–7, MDA)
- CI confidence interval, ED experience domain, EQ-5D-3L EuroQoL-Five Dimensions-Three Level Health Questionnaire, FACIT-F Functional Assessment of Chronic Illness Therapy-Fatigue, HAQ-DI Health Assessment Questionnaire-Disability Index, ID impact domain, MDA minimal disease activity, NA not assessed, Pain VAS Patient’s Assessment of Arthritis Pain visual analog scale, PASDAS Psoriatic Arthritis Disease Activity Score, PCS Physical Component Summary, PF physical functioning, PGJS-VAS Patient’s Global Joint and Skin Assessment visual analog scale, PGJS-VAS-PsO PGJS-VAS psoriasis question, PRO patient-reported outcome, SF-36v2 Short Form-36 Health Survey Version 2, acute, VAS visual analog scale
- *OPAL Broaden, N = 422; OPAL Beyond, N = 394; all treatment groups from each phase 3 study were pooled for analysis