Table 3.
Change in PSA outcome variables needed for assessing cDAPSA and MDA
Variable | UST Baseline |
TNFi Baseline |
UST Change at 6 months |
TNFi Change at 6 months |
cDAPSA | 31.0 (28.9 to 33.1) | 29.8 (27.9 to 31.7) | −13.7 (−15.5 to −11.8) | −14.6 (−16.2 to −13.0) |
Tender joint count—68 joints | 12.5 (11.2 to 13.7) | 11.3 (10.3 to 12.4) | −5.3 (−6.4 to −4.2) | −5.7 (−6.6 to −4.8) |
Swollen joint count—66 joints | 6.0 (5.2 to 6.8) | 5.8 (5.1 to 6.5) | −3.7 (−4.4 to −3.0) | −3.7 (−4.4 to −3.1) |
HAQ-DI assessment | 1.1 (1.1 to 1.2) | 1.2 (1.1 to 1.2) | −0.25 (−0.3 to −0.2) | −0.34 (−0.4 to −0.3) |
Physician Global Assessment of Disease—VAS, mm | 53.5 (51.6 to 55.3) | 54.7 (52.7 to 56.6) | −23.3 (−25.7 to −20.8) | −24.9 (−27.3 to −22.6) |
Patient Global Assessment of Disease— VAS, mm | 61.1 (58.8 to 63.5) | 61.1 (58.7 to 63.4) | −20.7 (−23.5 to −18.0) | −25.2 (−28.2 to −22.3) |
Patient assessment of pain—VAS*, mm | 60.6 (58.1 to 63.0) | 61.2 (58.9 to 63.5) | −19.1 (−21.9 to −16.2) | −24.4 (−27.2 to −21.6) |
Total enthesitis score (LEI) | 2.6 (2.4 to 2.8) | 2.6 (2.4 to 2.8) | −1.4 (−1.6 to −1.2) | −1.5 (−1.7 to −1.2) |
Psoriasis BSA distribution, n (%) (95% CI) | ||||
Clear/almost clear skin | 99 (28.8) (24.1 to 33.9) | 123 (34.1) (29.2 to 39.2) | 312 (59.1) (54.8 to 63.3) | 335 (63.6) (59.3 to 67.7) |
<3% but not clear/almost clear | 33 (9.6) (6.7 to 13.2) | 58 (16.1) (12.4 to 20.3) | 70 (13.3) (10.5 to 16.5) | 85 (16.1) (13.1 to 19.6) |
3%‒10% | 120 (34.9) (29.9 to 40.2) | 129 (35.7) (30.8 to 40.9) | 133 (25.2) (21.5 to 29.1) | 93 (17.6) (14.5 to 21.2) |
>10% | 92 (26.7) (22.1 to 31.8) | 51 (14.1) (10.7 to 18.2) | 13 (2.5) (1.3 to 4.2) | 14 (2.7) (1.5 to 4.4) |
Psoriasis BSA improvement† from baseline, n (%) | – | – | 184 (53.5) (48.1 to 58.9) | 166 (46.0) (40.8 to 51.3) |
Data are observed mean (95% CI) at month 6 (last observation carried forward), unless otherwise indicated.
*There was a significantly higher percentage of UST patients with chronic widespread pain (FiRST score).
†Improvement: at least one category.
BSA, body surface area; cDAPSA, clinical Disease Activity Index for Psoriatic Arthritis; HAQ-DI, Health Assessment Questionnaire Disability Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; PsA, psoriatic arthritis; TNFi, tumour necrosis factor inhibitor; UST, ustekinumab; VAS, visual analogue scale.