TABLE 3.
Proportions and IRs of deaths and adverse events of special interest in OCTAVE Open
| Tofacitinib 5 mg b.d. (N = 175; 643.7 PY) | Tofacitinib 10 mg b.d. (N = 769; 1797.0 PY) | Tofacitinib All (N = 944; 2440.8 PY) | ||||
|---|---|---|---|---|---|---|
| n (%) | IR a (95% CI) | n (%) | IR a (95% CI) | n (%) | IR a (95% CI) | |
| Deaths b | 0 (0.0) | 0.00 (0.00‐0.57) | 6 (0.8) | 0.33 (0.12‐0.73) | 6 (0.6) | 0.25 (0.09‐0.54) |
| Serious infections c | 8 (4.6) d | 1.25 (0.54‐2.46) | 31 (4.0) e | 1.74 (1.18‐2.47) | 39 (4.1) | 1.61 (1.14‐2.20) |
| Herpes zoster (non‐serious and serious) c , f | 13 (7.4) | 2.08 (1.11‐3.55) | 60 (7.8) g | 3.55 (2.71‐4.58) | 73 (7.7) | 3.16 (2.47‐3.97) |
| Serious herpes zoster c | 1 (0.6) | 0.16 (0.00‐0.87) | 6 (0.8) | 0.33 (0.12‐0.73) | 7 (0.7) | 0.29 (0.12‐0.59) |
| Opportunistic infections c , h , i , j | 4 (2.3) | 0.63 (0.17‐1.60) | 17 (2.2) | 0.96 (0.56‐1.53) | 21 (2.2) | 0.87 (0.54‐1.33) |
| Malignancies excluding NMSC b , h | 7 (4.0) | 1.09 (0.44‐2.25) | 18 (2.3) | 1.00 (0.60‐1.59) | 25 (2.6) | 1.03 (0.67‐1.52) |
| NMSC b , h | 6 (3.4) | 0.96 (0.35‐2.08) | 12 (1.6) | 0.68 (0.35‐1.19) | 18 (1.9) | 0.75 (0.45‐1.19) |
| MACE b , h | 2 (1.1) | 0.31 (0.04‐1.13) | 2 (0.3) | 0.11 (0.01‐0.40) | 4 (0.4) | 0.16 (0.04‐0.42) |
| Gastrointestinal perforations c , h , k | 1 (0.6) | 0.16 (0.00‐0.87) | 1 (0.1) | 0.06 (0.00‐0.31) | 2 (0.2) | 0.08 (0.01‐0.30) |
| Deep vein thrombosis c | 0 (0.0) | 0.00 (0.00‐0.57) | 1 (0.1) | 0.06 (0.00‐0.31) | 1 (0.1) | 0.04 (0.00‐0.23) |
| Pulmonary embolism c | 0 (0.0) | 0.00 (0.00‐0.57) | 5 (0.7) | 0.28 (0.09‐0.65) | 5 (0.5) | 0.21 (0.07‐0.48) |
b.d., twice daily; CI, confidence interval; IR, incidence rate; MACE, major adverse cardiovascular events; N, number of patients who received at least one dose of study drug; n, number of patients with the specified event within the given category; NMSC, non‐melanoma skin cancer; PY, patient‐years.
IRs were calculated as the number of unique patients with events per 100 PY.
All events, including those outside the 28‐day risk period, were included.
All events occurred within 28 days after the last dose of study drug.
Three events were reported as severe (number of events): complicated appendicitis (1), gastroenteritis norovirus (1), necrotising fasciitis (1).
Sixteen events were reported as severe in a total of 13 patients (number of events): appendicitis (3), arthritis bacterial (1), atypical pneumonia (1), herpes zoster (3), herpes zoster meningitis (1), mastoiditis (1), meningitis viral (1), ophthalmic herpes zoster (1), osteomyelitis (1), perirectal abscess (1) sinusitis (1), wound infection (1).
Includes all herpes zoster events, including those classified as opportunistic infections.
Five events were reported as severe.
Adjudicated events.
Excludes tuberculosis and herpes zoster with two adjacent dermatomes; only multidermatomal herpes zoster (events that were non‐adjacent or with more than two adjacent dermatomes that were not considered disseminated) and disseminated herpes zoster (defined as any of: diffuse rash [>6 dermatomes], encephalitis, pneumonia or other non‐skin organ involvement) were classified as opportunistic infections.
Non‐herpes zoster opportunistic infections included a pulmonary mycosis (invasive cryptococcosis) case in the tofacitinib 5 mg b.d. group, and one case each of histoplasmosis, cytomegalovirus (CMV) infection and CMV hepatitis in the tofacitinib 10 mg b.d. group.
Excludes preferred terms of pilonidal cyst, perirectal abscess, rectal abscess, anal abscess, perineal abscess and any preferred terms containing the term fistula.