Summary of baseline patient and disease characteristics among randomised PsA patients with peripheral arthritis with and without physician-reported spondylitis at baseline in PSUMMIT-1 and PSUMMIT-2
| Spondylitis | Non-spondylitis | |||
|---|---|---|---|---|
| Placebo | Ustekinumab | Total | ||
| Patients randomised, N | 92 | 164 | 256 | 671 |
| Age (years), mean (SD) | 47.4 (12.78) | 45.7 (11.68) | 46.3 (12.08) | 47.8 (12.00) |
| Female, n (%) | 47 (51.1) | 69 (42.1) | 116 (45.3) | 333 (49.6) |
| BMI (kg/m2), mean (SD) | 29.5 (6.60) | 29.3 (6.74) | 29.4 (6.68) | 31.4 (7.39) |
| Number of swollen joints (0–66), mean (SD) | 14.6 (10.15) | 13.6 (9.41) | 14.0 (9.7) | 13.6 (9.13) |
| Number of tender joints (0–68), mean (SD) | 24.3 (14.20) | 24.2 (15.03) | 24.3 (14.71) | 24.1 (14.63) |
| HAQ-DI score (0–3), mean (SD) | 1.4 (0.59) | 1.3 (0.63) | 1.3 (0.62) | 1.2 (0.66) |
| CRP (mg/L), mean (SD) | 18.6 (24.89) | 22.5 (27.89) | 21.1 (26.87) | 17.2 (20.92) |
| PsA subtypes, n (%) | ||||
| DIP joint arthritis | 1 (1.1) | 2 (1.2) | 3 (1.2) | 109 (16.2) |
| Arthritis mutilans | 0 | 0 | 0 | 5 (0.7) |
| Asymmetric peripheral arthritis | 0 | 1 (0.6) | 1 (0.4) | 192 (28.6) |
| Polyarticular arthritis, no rheumatoid nodules | 1 (1.1) | 2 (1.2) | 3 (1.2) | 359 (53.5) |
| Spondylitis with peripheral arthritis | 90 (97.8) | 159 (97.0) | 249 (97.3) | 6 (0.9) |
| PsA duration (years), mean (SD) | 7.5 (8.94) | 6.5 (6.44) | 6.9 (7.44) | 7.1 (7.71) |
| Psoriasis duration (years), mean (SD) | 16.0 (12.62) | 15.9 (11.51) | 15.9 (11.89) | 15.1 (12.59) |
| Patients taking MTX, n (%) | 37 (40.2) | 85 (51.8) | 122 (47.7) | 329 (49.0) |
| DAS28, mean (SD) | 5.2 (1.08) | 5.3 (1.00) | 5.3 (1.03) | 5.2 (1.01) |
| Patients with digits with dactylitis, n (%) | 46 (50.0) | 86 (52.4) | 132 (51.6) | 291 (43.4) |
| Dactylitis score (1–60), mean (SD) | 9.3 (12.03) | 8.5 (10.35) | 8.7 (10.92) | 9.0 (10.54) |
| Patients with enthesitis, n (%) | 71 (77.2) | 135 (82.3) | 206 (80.5) | 456 (68.0) |
| Enthesitis score (MASES, 1–15), mean (SD) | 5.2 (3.93) | 6.1 (3.74) | 5.8 (3.81) | 5.4 (3.91) |
| Patients with radiographic erosion, n/N (%) | 84/92 (91.3) | 149/162 (92.0) | 233/254 (91.7) | 585/655 (89.3) |
| BASDAI score (1–10), mean (SD) | 6.4 (1.68) | 6.7 (1.59) | 6.6 (1.63) | n/a |
| BASDAI question 2 score (1–10), mean (SD) | 6.3 (2.67) | 6.8 (2.23) | 6.6 (2.41) | n/a |
| Patients with ≥3% BSA psoriasis skin involvement, n (%) | 69 (75.0) | 137 (83.5) | 206 (80.5) | 475 (71.0) |
| BSA (%), mean (SD) | 28.4 (26.10) | 30.1 (25.60) | 29.6 (25.72) | 17.9 (19.94) |
| PASI score (0–72), mean (SD) | 13.9 (12.55) | 14.8 (12.36) | 14.5 (12.40) | 10.4 (9.36) |
| DLQI (0–30), mean (SD) | 12.6 (7.84) | 12.3 (7.05) | 12.4 (7.31) | 11.0 (7.54) |
BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BMI, body mass index; BSA, body surface area; CRP, C reactive protein; DAS-28, 28-joint disease activity score; DIP, distal interphalangeal; DLQI, Dermatology Life Quality Index; HAQ-DI, Health Assessment Questionnaire-Disability Index; MASES, Maastricht Ankylosing Spondylitis Enthesitis Score; MTX, methotrexate; n/a, not applicable; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis.