Table 1.
Key demographics and baseline characteristics for patients in the OLE
| Demographics | By dose received in period A and the OLE | ||
|---|---|---|---|
|
pbo/ADA N = 94 |
ADA/ADA N = 94 |
||
| n (%) | n (%) | ||
| Sex | Male | 76 (80.9) | 83 (88.3) |
| Female | 18 (19.1) | 11 (11.7) | |
| Race | White | 90 (95.7) | 89 (94.7) |
| Asian | 3 (3.2) | 4 (4.3) | |
| Other† | 1 (1.1) | 1 (1.1) | |
| BSA of Ps | 5% to < 10% | 34 (36.2) | 37 (39.4) |
| ≥10% | 60 (63.8) | 57 (60.6) | |
| PGA‐F | Moderate | 53 (56.4) | 44 (46.8) |
| >Moderate | 41 (43.6) | 50 (53.2) | |
| PGA‐S | Moderate | 55 (58.5) | 56 (59.6) |
| >Moderate | 39 (41.5) | 37 (39.4) | |
| Scalp psoriasis | 80 (85.1) | 80 (85.1) | |
| Psoriatic arthritis | 26 (27.7) | 28 (29.8) | |
| Characteristics | Mean [SD]‡ | Mean [SD]‡ | |
|---|---|---|---|
| Age, years | 47.1 [11.44] | 47.3 [11.82] | |
| Body mass index, kg/m2 |
(N = 93) 29.2 [6.88] |
(N = 93) 29.6 [5.09] |
|
| Weight, kg | 88.6 [20.07] | 91.7 [17.27] | |
| Duration of psoriasis, years | 18.7 [13.73] | 20.7 [12.34] | |
| Duration of nail psoriasis, years | 12.0 [11.12] | 12.4 [9.65] | |
| PASI score | 13.3 [9.87] | 12.8 [9.00] | |
| Total‐fingernail mNAPSI score (range 0–130)‡ | 58.6 [20.78] | 57.0 [18.34] | |
| Total‐fingernail mNAPSI score (range 0–130)‡, median [Q1, Q3] | 57.0 [46, 73] | 57.0 [44, 68] | |
| Onycholysis or oil‐drop dyschromia | 16.5 [12, 23] | 17.5 [12, 22] | |
| Pitting | 13.0 [10, 18] | 14.0 [9, 18] | |
| Nail plate crumbling | 8.0 [4, 16] | 9.0 [5, 14] | |
| Leukonychia | 6.0 [2, 9] | 5.0 [2, 8] | |
| Splinter haemorrhage | 4.0 [2, 7] | 5.0 [3, 7] | |
| Nail bed hyperkeratosis | 6.5 [2, 10] | 6.0 [2, 9] | |
| Red spots in lunula | 0 [0, 2] | 0 [0, 2] | |
| Total‐fingernail NAPSI score (range 0–80)§ | 46.6 [15.40] | 48.0 [15.67] | |
| Nail psoriasis pain (NRS) score (range 0–10)§ | 5.7 [2.25] | 5.0 [2.48] | |
| B‐SNIPI, scalp component (range 0–20)§ |
(N = 16) 7.9 [5.82] |
(N = 23) 9.7 [5.32] |
|
| NPPFS score (range 0–10)§ | 5.2 [2.15] | 5.23 [2.63] | |
| Nail Ps QoL (range 0–10)¶ | 5.2 [2.28] | 4.9 [2.79] | |
| NAPPA QoL (range 0–4)§ | 3.1 [0.83] | 3.1 [0.87] |
†Other includes multirace (n = 1 for pbo/ADA) and black (n = 1 for ADA/ADA). ‡All are mean [SD] unless otherwise indicated. §Higher score indicates higher severity or impairment. ¶0 indicates no impact on quality of life; 10 indicates severe impact.
ADA, adalimumab; B‐SNIPI, Brigham Scalp Nail Inverse Palmo‐Plantar Psoriasis Index; DLQI, Dermatology Life Quality Index; NAPPA, Nail Assessment of Psoriasis and Psoriatic Arthritis; NAPSI, Nail Psoriasis Severity Index (m, modified); NPPFS, Nail Psoriasis Physical Functioning Severity; NRS, Numeric Rating Scale; OLE, open‐label extension; PASI, Psoriasis Area Severity Index; pbo, placebo; PGA, Physician's Global Assessment of psoriasis (‐F, fingernail; ‐S, skin); Ps, psoriasis; Q, quartile; QoL, quality of life, SD, standard deviation.