Baseline characteristics of, and adverse events reported by, randomized and treated COSMOS pts
| GUS 100 mg Q8W (N=189) | PBO (N=96) | |
| Age, y | 49 | 49 |
| Sex, Female | 54% | 46% |
| Duration of PsA, y | 8.3 | 8.7 |
| Body mass index, kg/m2 | 29 | 31a |
| Swollen (0-66) / tender (0-68) joint count | 10 / 21 | 9 / 18 |
| Pt pain / Pt global arthritis / Physician global disease, 0-10 cm VAS | 6.5 / 6.5 / 6.9 | 6.0 / 6.2 / 6.4 |
| Health Assessment Questionnaire-Disability Index, 0-3 | 1.3b | 1.2 |
| C-reactive protein, mg/dL | 1.2b | 1.2 |
| Methotrexate use at baseline | 56% | 53% |
| Psoriatic body surface area, % | 17.9 | 13.4 |
| Number of prior TNFi: 1 / 2 | 88% / 12% | 89% / 11% |
| Reason for prior TNFi discontinuation: Efficacy / Safety | 84% / 16%* | 81% / 19%* |
| Pts with ≥1 AE / SAE | 37% / 3% | 48% / 3% |
| Pts with ≥1 infection / serious infection | 18% / 0% | 20% / 0% |
| Pts with ≥1 AE leading to study agent discontinuation | 2% | 2% |
| Pts with ≥1 malignancy | 0.4% | 0 |
| Pts with ≥1 injection-site reaction | 2% | 1% |
Data shown are mean or %. aN=95; bN=188. *Missing for 1 pt. SAE – serious adverse events; VAS – visual analog scale