Incidence of serious infections, herpes zoster-related disease and malignancy per 100 patient-years, from week 0 to week 52 (SAF)
| Placebo (N=101) | Peficitinib 100 mg (N=104) | Peficitinib 150 mg (N=102) | Peficitinib 100 mg + 150 mg (N=206) | Peficitinib total* (N=296) | Etanercept (open-label arm) (N=200) | |
| Serious infections | ||||||
| Patient-years | 22.6 | 88.2 | 92.1 | 180.3 | 245.7 | 195.5 |
| Number of patients who had at least one incidence | 0 | 1 | 2 | 3 | 5 | 4 |
| Incidence rate/100 patient-years (95% CI) | 0.0 | 1.1 (0.2 to 8.1) | 2.2 (0.5 to 8.7) | 1.7 (0.5 to 5.2) | 2.0 (0.8 to 4.9) | 2.0 (0.8 to 5.5) |
| Herpes zoster-related disease (including varicella) | ||||||
| Patient-years | 22.6 | 86.8 | 90.9 | 177.7 | 241.2 | 194.0 |
| Number of patients who had at least one incidence | 0 | 5 | 4 | 9 | 14 | 5 |
| Incidence rate/100 patient-years (95% CI) | 0.0 | 5.8 (2.4 to 13.8) | 4.4 (1.7 to 11.7) | 5.1 (2.6 to 9.7) | 5.8 (3.4 to 9.8) | 2.6 (1.1 to 6.2) |
| Malignancies | ||||||
| Patient-years | 22.6 | 88.1 | 92.8 | 180.9 | 246.4 | 197.3 |
| Number of patients who had at least one incidence | 0 | 2 | 0 | 2 | 3 | 1 |
| Incidence rate/100 patient-years (95% CI) | 0.0 | 2.3 (0.6 to 9.1) | 0.0 (- to -) | 1.1 (0.3 to 4.4) | 1.2 (0.4 to 3.8) | 0.5 (0.1 to 3.6) |
Patient-years was calculated from initial dose up to first incidence of the event for patients who had at least one event, and from initial dose through follow-up for patients who had no events; incidence rate is calculated as (100 × number of patients who had at least one incidence/total patient-years).
*Included adverse events occurring during treatment with peficitinib in patients who were initially treated with placebo and switched to peficitinib at week 12.
SAF, safety analysis set.