Table 1.
Baseline demographics and clinical characteristics
| ITT study population | Patients with nail psoriasis at baseline and data available through week 16 | ||||||
|---|---|---|---|---|---|---|---|
| NAPSI 50 responders at week 16 | NAPSI 50 non-responders at week 16 | Overall (N = 31) | |||||
| ADA (N = 49) | PBO (N = 23) | ADA (N = 13) | PBO (N = 1) | ADA (N = 10) | PBO (N = 7) | ||
| Age, years, mean (SD)* | 49.0 (11.41) | 54.8 (11.40) | 56.7 (9.48) | 54.0 | 52.9 (9.24) | 56.6 (12.26) | 55.4 (9.74) |
| Age groups, n (%) | |||||||
| <40 years | 11 (22.4) | 1 (4.3) | 1 (7.7) | 0 | 1 (10.0) | 0 | 2 (6.5) |
| 40 to <65 years | 34 (69.4) | 19 (82.6) | 10 (76.9) | 1 (100) | 8 (80.0) | 6 (85.7) | 25 (80.6) |
| ≥65 years | 4 (8.2) | 3 (13.0) | 2 (15.4) | 0 | 1 (10.0) | 1 (14.3) | 4 (12.9) |
| Male, n (%)* | 21 (42.9) | 8 (34.8) | 5 (38.5) | 0 | 5 (50.0) | 3 (42.9) | 13 (41.9) |
| White, n (%)* | 45 (91.8) | 20 (87.0) | 12 (92.3) | 0 | 9 (90.0) | 6 (85.7) | 27 (87.1) |
| Bodyweight (kg), mean (SD) * | 90.4 (19.65) | 86.9 (18.66) | 84.8 (18.82) | 76.0 | 92.9 (22.41) | 95.4 (26.76) | 89.5 (21.53) |
| Bodyweight, n (%) | |||||||
| <88 kg | 21 (42.9) | 14 (60.9) | 8 (61.5) | 1 (100) | 3 (30.0) | 3 (42.9) | 15 (48.4) |
| ≥88 kg | 28 (57.1) | 9 (39.1) | 5 (38.5) | 0 | 7 (70.0) | 4 (57.1) | 16 (51.6) |
| Duration of psoriasis (years), Mean (SD)* | 14.9 (16.16) | 11.5 (9.94) | 20.4 (20.87) | 23.0 | 15.9 (17.11) | 14.1 (10.62) | 17.6 (17.11) |
| Duration of psoriasis hands/feet (years), Mean (SD)* | 10.0 (12.36) | 7.2 (6.69) | 8.6 (8.91) | 7.0 | 14.6 (17.57) | 9.8 (7.82) | 10.7 (12.01) |
| Duration of psoriasis hands/feet, n (%) | |||||||
| <4.7 years | 24 (49.0) | 12 (52.2) | 5 (38.5) | 0 | 5 (50.0) | 2 (28.6) | 12 (38.7) |
| ≥4.7 years | 25 (51.0) | 11 (47.8) | 8 (61.5) | 1 (100) | 5 (50.0) | 5 (71.4) | 19 (61.3) |
| Psoriatic arthritis, n (%)* | 7 (14.3) | 1 (4.3) | 0 | 0 | 1 (10.0) | 1 (14.3) | 2 (6.5) |
| Evidence of nail involvement, n (%)* | 28 (57.1) | 8 (34.8) | 13 (100) | 1 (100) | 10 (100) | 7 (100) | 31 (100) |
| hfPGA, n (%)* | |||||||
| Moderate | 37 (75.5) | 17 (73.9) | 11 (84.6) | 1 (100) | 5 (50.0) | 4 (57.1) | 21 (67.7) |
| Severe | 12 (24.5) | 6 (26.1) | 2 (15.4) | 0 | 5 (50.0) | 3 (42.9) | 10 (32.3) |
| Psoriasis of palms and soles, n (%)* | 39 (79.6) | 14 (60.9) | 13 (100) | 0 | 8 (80.0) | 4 (57.1) | 25 (80.6) |
| ESIF (0–48), Mean (SD)* | 25.9 (10.35) | 23.7 (9.11) | 27.9 (6.53) | 13.0 | 30.7 (12.19) | 26.9 (9.39) | 28.1 (9.46) |
| Target nail NAPSI (0–8), Mean (SD)*,† | 3.9 (1.95) | 3.3 (1.75) | 3.2 (2.08) | 2.0 | 4.8 (1.75) | 3.4 (1.81) | 3.7 (1.99) |
| Prior systemic therapy, n (%) | 23 (46.9) | 8 (34.8) | 7 (53.8) | 0 | 6 (60.0) | 5 (71.4) | 18 (58.1) |
| Smoker, n (%) | 16 (32.7) | 9 (39.1) | 4 (30.8) | 0 | 4 (40.0) | 2 (28.6) | 10 (32.3) |
| PASI score (0–72), mean (SD)* | 8.8 (8.23)‡ | 5.7 (4.52) | 11.2 (12.40) | 22.2 | 12.0 (9.51) | 3.4 (3.64) | 10.0 (10.42) |
| PASI score (0–72), n (%) | |||||||
| <10 at baseline | 37 (75.5) | 20 (86.9) | 9 (69.2) | 0 | 6 (66.7)‡ | 6 (85.7) | 21 (70.0)‡ |
| ≥10 at baseline | 11 (22.4) | 3 (13.4) | 4 (30.8) | 1 (100) | 3 (33.3)‡ | 1 (14.3) | 9 (30.0)‡ |
| % BSA (0–100), Mean (SD)‡ | 8.9 (11.88) | 5.1 (6.96) | 12.6 (17.80) | 35.0 | 13.1 (15.22) | 3.6 (3.15) | 11.4 (15.24) |
| DLQI (0–30), Mean (SD)* | 11.2 (6.95) | 13.3 (7.31) | 10.9 (8.67) | 12.0 | 14.5 (6.47) | 10.4 (4.89) | 12.0 (7.11) |
| VAS (0–100), Mean (SD)*,§ | 44.1 (27.63) | 55.3 (26.69) | 43.1 (23.61) | 39.0 | 53.0 (36.61) | 54.7 (19.73) | 48.8 (27.10) |
ITT, intent to treat population; ADA, adalimumab; PBO, placebo; SD, standard deviation; hfPGA, Physician’s Global Assessment of hands and/or feet; ESIF, Erythema, Scaling, Induration and Fissuring scale; NAPSI, Nail Psoriasis Severity Index; PASI, Psoriasis Area and Severity Index; BSA, body surface area; DLQI, Dermatology Life Quality Index; VAS, visual analogue scale of plaque psoriasis and psoriatic arthritis (PsA) pain.
*
Data for ITT population previously reported.25
†
For patients with nail involvement at baseline.
‡
Data missing for one patient.
§
Includes VAS for plaque psoriasis and PsA pain.