Patient characteristics at baseline
| Abatacept (n=213*) | Placebo (n=211*) | |
| Demographic characteristics | ||
| Age, years | 51.0 (10.7) | 49.8 (11.3) |
| Sex, female, n (%) | 121 (56.8) | 112 (53.1) |
| Race, white, n (%) | 195 (91.5) | 198 (93.8) |
| Body mass index, kg/m2 | 30.7 (6.3) | 31.3 (6.8) |
| Region, n (%) | ||
| South America | 95 (44.6) | 80 (37.9) |
| Europe | 53 (24.9) | 59 (28.0) |
| North America | 44 (20.7) | 40 (19.0) |
| Rest of World | 21 (9.9) | 32 (15.2) |
| Disease characteristics | ||
| PsA duration, years | 8.3 (8.1) | 8.8 (8.3) |
| TJC | 21.0 (13.4) | 19.3 (13.1) |
| SJC | 12.1 (7.8) | 11.1 (7.2) |
| DIP involvement,† n (%) | 114 (53.5) | 101 (47.9) |
| HAQ-DI | 1.3 (0.7) | 1.3 (0.7) |
| Patient Global Assessment of disease activity (VAS 0–100 mm) | 61.1 (23.5) | 62.6 (22.6) |
| Physician Global Assessment of disease activity (VAS 0–100 mm) | 53.9 (18.8) | 55.0 (19.6) |
| Patient Global Assessment of pain (VAS 0–100 mm) | 64.2 (23.5) | 64.4 (21.8) |
| CRP, mg/L | 14.0 (20.9) | 14.3 (30.3) |
| Elevated CRP (>ULN‡), n (%) | 146 (68.9) | 131 (62.7) |
| DAS28 (CRP) | 5.0 (1.1) | 4.9 (1.1) |
| PsA-modified total SHS | 20.0 (46.8) | 17.7 (39.6) |
| Psoriasis covering ≥3% BSA, n (%)§ | 146 (68.5) | 148 (70.1) |
| PASI score¶** | 7.4 (8.0) | 7.2 (7.8) |
| Enthesitis, n (%) | 140 (65.7) | 132 (62.6) |
| Dactylitis, n (%) | 61 (28.6) | 50 (23.7) |
| Anti-CCP positive (>10 U/mL), n (%) | 10 (5.1) | 2 (1.0) |
| Medication use | ||
| Prior TNFi, n (%) | 129 (60.6) | 130 (61.6) |
| 1 | 94 (44.1) | 92 (43.6) |
| 2 | 31 (14.6) | 36 (17.1) |
| ≥3 | 4 (1.9) | 2 (0.9) |
| Concomitant methotrexate, n (%) | 129 (60.6) | 127 (60.2) |
| Concomitant csDMARDs other than methotrexate, n (%) | 27 (12.7) | 25 (11.8) |
| Concomitant oral corticosteroids, n (%)** | 56 (26.3) | 51 (24.2) |
Data are presented as mean (SD) unless indicated otherwise.
*For the following assessments, patient numbers in the abatacept and placebo arms, respectively, were as follows: body mass index (212 and 210), HAQ-DI score (212 and 211), Patient Global Assessment of disease activity (211 and 210), Physician Global Assessment of disease activity (210 and 209), Patient Global Assessment of pain (213 and 210), elevated CRP (212 and 209), DAS28 (CRP) score (210 and 208), PsA-modified total SHS score (205 and 202), PASI score (145 and 148) and anti-CCP positive (196 and 198).
†One or more swollen or tender DIP joint.
‡ULN=3 mg/L.
§Of patients with psoriasis covering ≥3% of BSA in the abatacept and placebo arms, 55 and 51 were in the TNFi-naïve subgroup, and 91 and 97 were in the TNFi-exposed subgroup, respectively.
¶Measured only for patients with psoriasis covering ≥3% of BSA.
**Mean (SD) oral daily steroid dose at baseline (prednisone equivalent) abatacept, 6.8 (2.68); placebo, 6.3 (2.56).
BSA, body surface area; CCP, cyclic citrullinated peptide; CRP, C-reactive protein; csDMARD, conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP), Disease Activity Score 28 (C-reactive protein); DIP, distal interphalangeal; HAQ-DI, Health Assessment Questionnaire–Disability Index (range 0–3); PASI, Psoriasis Area and Severity Index (range 0–72); PsA, psoriatic arthritis; PsA-modified total SHS, psoriatic arthritis-modified total Sharp/van der Heijde score (range 0–528); SJC, swollen joint count (range 0–66); TJC, tender joint count (range 0–68); TNFi, tumour necrosis factor inhibitor; ULN, upper limit of normal; VAS, visual analogue scale.