| All Patients | 0–5 drugs | 6–9 drugs | >10 drugs | |
|---|---|---|---|---|
| PP count excluding DMARDs | ||||
| N=15,004 | n=7,115 | n=6,019 | n=1,870 | |
| Baseline characteristics | ||||
| Mean Age in years | 56.3 | 54.0 | 57.6 | 61.0 |
| Mean DAS 28 (SD) | 4.30 (1.76) | 4.17 (1.79) | 4.51 (1.67) | 4.88 (1.67) |
| Mean HAQ (SD) | 1.93 (0.64) | 1.85 (0.65) | 2.10 (0.56) | 2.15 (0.58) |
| Mean Disease Duration (SD) in years | 12.59 (9.72) | 11.96 (9.32) | 13.79 (10.26) | 14.67 (10.96) |
| Comorbidity (SD) | 1.87 (0.80) | 1.65 (0.74) | 2.29 (0.73) | 2.57 (0.68) |
| Analysis of Serious Adverse Events | ||||
| Exposure time (person-years) | 14,200 | 9,690 | 3,706 | 804 |
| Event count (single failure model) | 3261 | 2002 | 1251 | 368 |
| Incidence rate (95% CI) | 25.5 (24.7–26.3) | 20.6 (19.7–21.5) | 33.7 (31.9–35.6) | 45.7 (41.3–50.7) |
| Including DMARDs in PP model | ||||
| Unadjusted HR (95% CI) | – | Ref | 1.20 (1.11–1.29) | 1.82 (1.66–1.99) |
| Adjusted HR (95% CI) | – | Ref | 1.05 (0.97–1.13) | 1.39 (1.26–1.54) |
| Excluding DMARDs in PP model | ||||
| Unadjusted HR (95% CI) | – | Ref | 1.63 (1.52–1.75) | 2.21 (1.98–2.47) |
| Adjusted HR (95% CI) | – | Ref | 1.18 (1.09–1.28) | 1.35 (1.19–1.53) |
Adjusted for age, sex, DAS, HAQ, disease duration and comorbidities.