Table 1.
Demographics and baseline characteristics
| Characteristics | Placebo (n = 64) | Guselkumab | |
|---|---|---|---|
| 50 mg (n = 65) | 100 mg (n = 63) | ||
| Age, mean (SD), years | 48.3 (10.56) | 50.1 (12.66) | 47.8 (11.07) |
| Men, n (%) | 54 (84.4) | 44 (67.7) | 47 (74.6) |
| Bodyweight, mean (SD), kg | 71.56 (14.01)† | 67.76 (15.02) | 74.27 (16.04) |
| BMI, kg/m2, mean (SD) | 25.42 (4.791)† | 24.61 (4.514) | 26.33 (5.032) |
| Duration of psoriasis, mean (SD), years | 13.66 (10.291) | 15.25 (9.170) | 14.39 (9.227) |
| BSA of lesion (%), mean (SD) | 33.6 (18.39) | 38.0 (19.94) | 37.9 (21.48) |
| PASI score (0–72), mean (SD) | 25.92 (12.341) | 25.60 (11.680) | 26.73 (12.196) |
| IGA score (0–4), n (%) | |||
| Cleared (0) | 0 | 0 | 0 |
| Minimal (1) | 0 | 0 | 0 |
| Mild (2) | 0 | 1 (1.5) | 0 |
| Moderate (3) | 52 (81.3) | 50 (76.9) | 51 (81.0) |
| Severe (4) | 12 (18.8) | 14 (21.5) | 12 (19.0) |
| DLQI score (0–30), mean (SD) | 10.6 (7.74) | 10.4 (6.25) | 10.3 (7.27) |
| EQ‐5D score (0–100), mean (SD) | 61.6 (23.69) | 60.3 (23.34) | 59.8 (24.05) |
| SF‐36 PCS, mean (SD) | 46.0 (12.40) | 44.8 (16.47) | 45.7 (15.18) |
| SF‐36 MCS, mean (SD) | 44.6 (9.26) | 47.5 (9.18) | 46.3 (9.85) |
| NAPSI score (0–8), n ‡ | 42 | 44 | 40 |
| Mean (SD) | 3.6 (2.25) | 3.8 (1.96) | 3.7 (2.22) |
| Diagnosis of PsA§, n (%) | 10 (15.6) | 11 (16.9) | 10 (15.9) |
| Diagnosis of active PsA, n (%) | 4 (6.3) | 3 (4.6) | 3 (4.8) |
| ACR components, mean (SD) | |||
| Tender joint count | 2.6 (2.32) | 10.0 (15.13) | 5.1 (5.86) |
| Swollen joint count | 5.9 (7.14) | 4.1 (3.59) | 3.7 (4.76) |
| Patient's assessment of pain (VAS) | 5.90 (2.778) | 4.43 (3.028) | 3.01 (3.634) |
| Patient's global assessment of disease activity (VAS) | 6.48 (2.507) | 4.74 (2.876) | 3.51 (3.674) |
| Physician's global assessment of disease activity (VAS) | 4.73 (3.044) | 5.46 (2.979) | 2.90 (2.402) |
| Prior treatments, n (%) | |||
| Topical agents | 64 (100.0) | 65 (100.0) | 62 (98.4) |
| Phototherapy | 27 (42.2) | 39 (60.0) | 30 (47.6) |
| PUVA | 6 (9.4) | 15 (23.1) | 10 (15.9) |
| UV‐B | 24 (37.5) | 33 (50.8) | 22 (34.9) |
| Conventional systemic | 38 (59.4) | 40 (61.5) | 37 (58.7) |
| Apremilast | 2 (3.1) | 3 (4.6) | 0 |
| Cyclosporin | 34 (53.1) | 33 (50.8) | 28 (44.4) |
| Methotrexate | 7 (10.9) | 7 (10.8) | 6 (9.5) |
| Tofacitinib | 2 (3.1) | 0 | 0 |
| Biologic agents | 10 (15.6) | 14 (21.5) | 11 (17.5) |
| Adalimumab | 2 (3.1) | 7 (10.8) | 4 (6.3) |
| Brodalumab | 1 (1.6) | 0 | 2 (3.2) |
| Infliximab | 6 (9.4) | 5 (7.7) | 4 (6.3) |
| Ixekizumab | 0 | 1 (1.5) | 2 (3.2) |
| Secukinumab | 2 (3.1) | 2 (3.1) | 0 |
| Ustekinumab | 2 (3.1) | 7 (10.8) | 2 (3.2) |
† n = 63. ‡Patients diagnosed with nail psoriasis. §Diagnosis based on Classification Criteria for Psoriatic Arthritis (CASPAR). ACR, American College of Rheumatology; BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; EQ‐5D, EuroQol 5 dimensions questionnaire; IGA, Investigator's Global Assessment; IQ, interquartile range; PASI, Psoriasis Area and Severity Index; PCS, Physical Component Score; PSSD, Psoriasis Symptoms and Signs Diary; SF‐36, Medical Outcomes Study 36‐Item; PsA, psoriatic arthritis; PUVA, psoralen plus ultraviolet A light therapy; UV‐B, narrowband ultraviolet B therapy; VAS, visual analog scale.
[Correction added on 23 July 2018, after first online publication: The data in the following rows have been corrected; Apremilast, Cyclosporin, Methotrexate, Tofacitinib, Adalimumab, Brodalumab, Infliximab, Ixekizumab, Ustekinumab. Also, a new row for Secukinumab has been added under ‘Biologic agents’.]