OPAL Broaden | OPAL Beyond | ||||
Tofacitinib 5mg BID (N=107) | Placebo→tofacitinib 5 mg BID (N=52) | Adalimumab 40 mg Q2W (N=106) | Tofacitinib 5 mg BID (N=131) | Placebo→tofacitinib 5 mg BID (N=66) | |
Patient demographics | |||||
Age, years, mean (SD) | 49.4 (12.6) | 46.1 (10.4) | 47.4 (11.3) | 49.5 (12.3) | 48.7 (11.2) |
Female, n (%) | 57 (53.3) | 28 (53.8) | 50 (47.2) | 64 (48.9) | 38 (57.6) |
White race, n (%) | 105 (98.1) | 52 (100.0) | 103 (97.2) | 121 (92.4) | 60 (90.9) |
BMI, kg/m2, mean (SD) | 29.0 (5.2) | 30.0 (6.3) | 28.8 (5.3) | 30.5 (7.1) | 30.0 (5.3) |
Baseline disease characteristics | |||||
PsA duration, years, mean (SD) | 7.3 (8.2) | 7.8 (7.7) | 5.3 (5.3) | 9.6 (7.6) | 8.2 (7.1) |
VAS pain score, mm | |||||
Mean (SD) | 55.7 (22.8) | 56.1 (21.8) | 50.7 (21.7)‡ | 56.4 (24.1)§ | 56.4 (25.6) |
Median (range) (IQR) | 54.0 (3.0–97.0) (44.0–76.0) | 57.5 (13.0–97.0) (42.0–71.5) | 52.0 (3.0–92.0) (37.0–67.0)‡ | 58.0 (1.0–99.0) (40.0–74.0)§ | 59.0 (2.0–100.0) (37.0–76.0) |
LEI score, mean (SD) (n)† | 2.5 (1.4) (75) | 2.7 (1.4) (31) | 2.3 (1.2) (76) | 3.0 (1.6) (83) | 3.1 (1.7) (47) |
DSS, mean (SD) (n)† | 9.1 (8.0) (61) | 10.5 (9.5) (29) | 8.0 (7.4) (58) | 7.8 (9.9) (66) | 7.3 (5.7) (30) |
Swollen joint count (of 66 joints assessed), mean (SD) | 12.9 (9.9) | 11.0 (7.9) | 9.8 (7.9) | 12.1 (10.6) | 11.0 (9.9) |
Tender/painful joint count (of 68 joints assessed), mean (SD) | 20.5 (12.6) | 21.9 (16.2) | 17.1 (11.2) | 20.5 (13.0) | 21.0 (16.2) |
*Further details are available elsewhere.25 26
†For patients with score >0 at baseline.
‡N=105.
§N=130.
BID, twice daily; BMI, body mass index; DSS, Dactylitis Severity Score; LEI, Leeds Enthesitis Index; N, total number of patients in that group; n, number of patients with characteristic; PsA, psoriatic arthritis; Q2W, once every 2 weeks; VAS, Visual Analogue Scale.