Table 1.
Baseline characteristics of COSMOS participants
| Randomised, treated participants, N | Guselkumab 100 mg Q8W |
Placebo | Total |
| 189 | 96 | 285 | |
| Age, years | 49 [12] | 49 [12] | 49 [12] |
| <65 | 169 (89%) | 89 (93%) | 258 (91%) |
| ≥65 | 20 (11%) | 7 (7%) | 27 (9%) |
| Sex | |||
| Male | 86 (46%) | 52 (54%) | 138 (48%) |
| Female | 103 (54%) | 44 (46%) | 147 (52%) |
| Weight, kg | 84 [17] | 92 [23] | 86 [20] |
| Body mass index, kg/m2 | 29 [6] | 31 [7]* | 30 [6]† |
| Swollen joint count, 0–66 | 10 [7] | 9 [6] | 10 [6] |
| Tender joint count, 0–68 | 21 [13] | 18 [11] | 20 [12] |
| PsA disease duration, years | 8.3 (7.8) | 8.7 (7.2) | 8.4 (7.6) |
| Patient assessment of pain, 0–10 cm VAS | 6.5 (1.9) | 6.0 (1.8) | 6.3 (1.9) |
| Patient global assessment of arthritis, 0–10 cm VAS | 6.5 (1.7) | 6.2 (1.7) | 6.4 (1.7) |
| Physician global assessment of disease, 0–10 cm VAS | 6.9 (1.5) | 6.4 (1.7) | 6.7 (1.6) |
| HAQ-DI, 0–3 | 1.3 (0.6)‡ | 1.2 (0.6) | 1.3 (0.6)† |
| CRP, mg/dL | 1.2 (2.0)‡ | 1.2 (2.5) | 1.2 (2.2)† |
| Enthesitis (LEI score ≥1) | 126 (67%) | 64 (67%) | 190 (67%) |
| LEI score, 1–6 | 2.9 (1.5) | 2.7 (1.5) | 2.8 (1.5) |
| Dactylitis (DSS ≥1) | 67 (36%) | 36 (38%) | 103 (36%) |
| DSS, 1–60 | 6.7 (6.5) | 7.4 (8.3) | 6.7 (7.1) |
| DAPSA score | 45.5 (19.9) | 40.6 (15.8) | 43.8 (18.7) |
| Psoriatic BSA, % | 17.9 (21.5) | 13.4 (17.7) | 16.4 (20.4) |
| PASI score, 0–72, N | 188 | 96 | 284 |
| Mean (SD) | 11.7 (11.9) | 9.2 (9.4) | 10.9 (11.2) |
| <12 | 119 (63%) | 65 (68%) | 184 (65%) |
| ≥12 and <20 | 33 (18%) | 19 (20%) | 52 (18%) |
| ≥20 | 36 (19%) | 12 (13%) | 48 (17%) |
| IGA score, 0–4, N | 189 | 96 | 285 |
| <2 | 40 (21%) | 29 (30%) | 69 (24%) |
| ≥2 | 149 (79%) | 67 (70%) | 216 (76%) |
| SF-36, standard norm=50 | |||
| PCS score | 33.0 (7.0)‡ | 33.9 (7.7) | 33.3 (7.3)† |
| MCS score | 47.1 (12.1)‡ | 46.1 (11.5) | 46.8 (11.9)† |
| FACIT-F score, 0–52 | 29.2 (11.3)‡ | 29.2 (10.6) | 29.2 (11.0)† |
| No of prior TNFi | |||
| 1 | 167 (88%) | 85 (89%) | 252 (88%) |
| 2 | 22 (12%) | 11 (11%) | 33 (12%) |
| Reason for prior TNFi discontinuation | |||
| Inadequate efficacy | 159 (84%) | 79 (82%) | 238 (84%) |
| Intolerance | 30 (16%) | 17 (18%) | 47 (16%) |
| MTX use at baseline | 105 (56%) | 51 (53%) | 156 (55%) |
Data are mean (SD) or n (%) unless stated otherwise.
*N=95
†N=284
‡N=188
BSA, body surface area; CRP, C reactive protein; DAPSA, Disease Activity in Psoriatic Arthritis; DSS, Dactylitis Severity Score; FACIT-F, Functional Assessment of Chronic Illness Therapy-Fatigue; HAQ-DI, Health Assessment Questionnaire-Disability Index; IGA, Investigator’s Global Assessment of psoriasis; LEI, Leeds Enthesitis Index; MCS, mental component summary; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; PCS, physical component summary; PsA, psoriatic arthritis; Q8W, every 8 weeks; SF-36, 36-item Short-Form Health Survey; TNFi, tumour necrosis factor inhibitor; VAS, visual analogue scale.