Table 5.
Summary of safety and incidence rates and 95% confidence intervals for safety events of special interest in the tofacitinib dose escalation subpopulation of OCTAVE Open
| Tofacitinib maintenance failure dose escalation subpopulation (N = 57) (Overall exposure: 102.1 patient‐years)a | |
|---|---|
| Patients with adverse events, n (%) | 43 (75.4) |
| Patients with serious adverse events, n (%) | 6 (10.5) |
| Discontinuations, n (%) | 32 (56.1) |
| Due to adverse event (excluding adverse events of worsening UC) | 1 (1.8) |
| Due to insufficient clinical response (including adverse events of UC) | 25 (43.9) |
| n (%) | Incidence rate (95% confidence interval) | |
|---|---|---|
| Serious adverse events | 5 (8.8) | 4.9 (1.6, 11.5) |
| Serious infections | 1 (1.8) | 1.0 (0.0, 5.5) |
| Herpes zoster | 7 (12.3) | 7.6 (3.0, 15.6) |
| Herpes zoster serious adverse events | 0 (0.0) | 0.0 (0.0, 3.6) |
| Opportunistic infectionsb | 0 (0.0) | 0.0 (0.0, 3.6) |
| Malignancies (excluding non‐melanoma skin cancer)b | 1 (1.8) | 1.0 (0.0, 5.5) |
| Non‐melanoma skin cancerb | 1 (1.8) | 1.0 (0.0, 5.5) |
| Major adverse cardiovascular eventsb | 0 (0.0) | 0.0 (0.0, 3.6) |
| Gastrointestinal perforationsb | 0 (0.0) | 0.0 (0.0, 3.6) |
| Deaths | 0 (0.0) | 0.0 (0.0, 3.6) |
Abbreviations: N, number of evaluable patients; n, number of unique patients with one or more events; UC, ulcerative colitis.
a
Patient‐years of exposure for incidence rates was calculated up to the earliest of: day of the first event, time to data cut‐off or progression to the next study, or time to last dose plus 28 days. Exposure time per event could be different from overall exposure.
b
Per adjudication.