Table 2.
Annualised incidence of pericarditis episodes prior to and during the study
|
Disease status |
Idiopathic | PPS | |||
| Active* | Active† | CS-dep‡ | Active§ | CS-dep¶ | |
| CRP requirement (mg/dL) | >1 | ≤1 | N/A | >1 | N/A |
| N | 12 | 3 | 6 | 1 | 3 |
| Prior to the study** | |||||
| Pericarditis episodes per year, mean (median, range, SD) | 4.4 (2.4, 0.5–15.0, 4.68) | 2.0 (1.0, 1.0–4.0, 1.75) | 4.5 (3.4, 1.9–8.6, 2.58) | 1.3 | 3.7 (2.5, 1.5–7.1, 3.02) |
| During the study†† | |||||
| Patients with pericarditis episodes, n | 1‡‡ | 0 | 0 | 0 | 0 |
| Pericarditis episodes per year, mean (SD) | 0.18 (0.62) | 0 | 0 | 0 | 0 |
*Part 1.
†Part 2.
‡Part 3.
§Part 4.
¶Part 5.
**Annualised incidence of pericarditis episodes prior to the study was calculated by dividing the number of episodes (including index, prior recurrences and qualifying episode if applicable) by disease duration in years.
††Annualised incidence of pericarditis episodes during the study was calculated by dividing the number of recurrences during the study by duration of follow-up during the study in years.
‡‡One subject in part 1 presented with increase in pericarditis chest pain from 0 to 2 for 5 days; no medication was added; at visit, CRP was 0.1 mg/dL; it was reported as a pericarditis recurrence by the investigator.
CRP, C reactive protein; CS-dep, corticosteroid dependent; PPS, postpericardiotomy syndrome.;