Table 1.
Demographics and treatment outcomes of the randomly selected participants from the DISCOVER studies and demographics of the healthy controls used for the biomarker studies
| Guselkumab 100 mg q4w | Guselkumab 100 mg q8w | Placebo | Healthy | ||
| n=101 | n=100 | n=99 | n=34 | ||
| Demographics | |||||
| Age, years | Mean (SD) | 47.4 (10.7) | 47.3 (11.8) | 47.7 (11.3) | 46.6 (11.9) |
| Sex, n (%) | Female | 51 (50.5) | 46 (46.0) | 49 (49.5) | 18 (52.9) |
| Male | 50 (49.5) | 54 (54.0) | 50 (50.5) | 16 (47.1) | |
| Race, n (%) | White | 97 (96.0) | 95 (95.0) | 94 (94.9) | 33 (97.1) |
| BMI | Mean (SD) | 29.5 (5.6) | 29.8 (6.4) | 29.7 (6.1) | NR |
| Baseline disease | |||||
| Psoriasis disease duration (years) | Mean (SD) | 16.9 (12.8) | 17.0 (12.6) | 17.0 (12.3) | |
| PsA disease duration (years) | Mean (SD) | 7.0 (6.9) | 5.1 (4.8) | 7.0 (5.8) | |
| Body surface area affected by psoriasis (%) | Mean (SD) | 14.9 (18.0) | 16.8 (21.5) | 13.3 (17.4) | |
| PASI | Mean (SD) | 10.1 (11.8) | 9.6 (11.2) | 7.8 (9.7) | |
| Swollen joint count (66) | Mean (SD) | 10.9 (7.4) | 11.8 (8.5) | 11.4 (6.4) | |
| Tender joint count (68) | Mean (SD) | 20.3 (13.5) | 20.9 (13.0) | 20.5 (14.7) | |
| Enthesitis | Number (%) | 68 (67.3) | 65 (65.0) | 60 (60.6) | |
| Dactylitis | Number (%) | 36 (35.6) | 40 (40.0) | 36 (36.4) | |
| Baseline medication usage | |||||
| Prior anti-TNF use | Number (%) | 16 (15.8) | 16 (16.0) | 16 (16.2) | |
| No of prior anti-TNF agents | 1 | 13 (12.9) | 13 (13.0) | 14 (14.1) | |
| 2 | 3 (3.0) | 3 (3.0) | 2 (2.0) | ||
| Current conventional synthetic DMARDs including MTX | Number (%) | 68 (67.3) | 71 (71.0) | 65 (65.7) | |
| No of prior DMARDs | 0 | 11 (10.9) | 11 (11.0) | 6 (6.1) | |
| 1 | 55 (54.5) | 63 (63.0) | 62 (62.6) | ||
| 2 | 29 (28.7) | 19 (19.0) | 23 (23.2) | ||
| 3+ | 6 (5.9) | 7 (7.0) | 8 (8.1) | ||
| Current MTX use | Number (%) | 59 (58.4) | 57 (57.0) | 52 (52.5) | |
| Current conventional synthetic DMARDs other than MTX | Number (%) | 9 (8.9) | 12 (12.0) | 13 (13.1) | |
| Current oral corticosteroid use for PsA | Number (%) | 19 (18.8) | 18 (18.0) | 22 (22.2) | |
| Current NSAID use for PsA | Number (%) | 58 (57.4) | 63 (63.0) | 65 (65.7) | |
| Clinical efficacy endpoints | Number (%) | ||||
| ACR20 response at week24 | Responder | 61 (60.4) | 60 (60.0) | 26 (26.3) | |
| Non-responder | 40 (39.6) | 40 (40.0) | 73 (73.7) | ||
| ACR50 response at week 24 | Responder | 36 (35.6) | 27 (27.0) | 12 (12.1) | |
| Non-responder | 65 (64.4) | 73 (73.0) | 87 (87.9) | ||
| IGA Response at week 24 | Responder | 49 (70.0) | 49 (69.0) | 10 (15.6) | |
| Non-responder | 21 (30.0) | 22 (31.0) | 54 (84.4) | ||
| PASI75 Response at week 24 | Responder | 86 (85.2) | 81 (81.0) | 20 (20.2) | |
| Non-responder | 15 (14.9) | 19 (19.0) | 79 (79.8) | ||
ACR, American College of Rheumatology response criteria; BMI, body mass index; DMARDs, disease modifying anti-rheumatic drugs; IGA, Investigator Global Assessment; MTX, methotrexate; NR, not recorded; NSAID, non-steroidal anti-inflammatory drug; PASI75, Psoriatic Area and Severity Index ≥75%; PASI, Psoriasis Area and Severity Index; PsA, psoriatic arthritis; q4w, every 4 weeks; q8w, every 8 weeks; TNF, tumour necrosis factor.