IRs (95% CI) for AEs of special interest
| RA (N=7964) | PsA (N=783) | UC (N=1157) | PsO (N=3663) | |
| Total tofacitinib exposure, patient-years | 23 497 | 2038 | 2581 | 8950 |
| Serious infections, IR (95% CI) (n) | 2.5 (2.3 to 2.7) (592) | 1.2 (0.7 to 1.7) (24) | 1.7 (1.2 to 2.3) (45) | 1.3 (1.1 to 1.5) (119) |
| All HZ (non-serious and serious), IR (95% CI) (n) | 3.6 (3.3 to 3.8) (795) | 1.8 (1.2 to 2.4) (36) | 3.5 (2.8 to 4.3) (87) | 2.4 (2.0 to 2.7) (209) |
| Adjudicated OIs excluding tuberculosis, IR (95% CI) (n) | 0.4 (0.3 to 0.5) (95) | 0.3 (0.1 to 0.7) (7) | 1.6 (1.1 to 2.1) (40)* | 0.3 (0.2 to 0.5) (29) |
| Adjudicated tuberculosis, IR (95% CI) (n) | 0.2 (0.1 to 0.2) (38) | 0.0 (0.0 to 0.2) (0) | 0.0 (0.0 to 0.1) (0)* | 0.0 (0.0 to 0.1) (1) |
| Adjudicated malignancies excluding all NMSC, IR (95% CI) (n) n1 (%) | 0.7 (0.6 to 0.9) (179) 211 (2.6) | 0.7 (0.4 to 1.2) (15) 18 (2.3) | 0.6 (0.3 to 1.0) (16)* 20 (1.8)* | 0.7 (0.5 to 0.8) (60) 74 (2.0) |
| Adjudicated NMSC, IR (95% CI) (n) n1 (%) | 0.6 (0.5 to 0.7) (133) 135 (1.7) | 0.8 (0.4 to 1.3) (16) 16 (2.0) | 0.7 (0.4 to 1.1) (19)* 19 (1.7)* | 0.7 (0.5 to 0.9) (63) 67 (1.8) |
| Adjudicated melanoma, IR (95% CI) (n) n1 (%) | 0.1 (0.0 to 0.1) (14) 14 (0.2) | 0.0 (0.0 to 0.2) (0) 0 (0.0) | 0.1 (0.0 to 0.3) (2)* 2 (0.2)* | 0.1 (0.0 to 0.1) (5) 5 (0.1) |
| Adjudicated lymphoma/lymphoproliferative disorders, IR (95% CI) (n) n1 (%) | 0.1 (0.0 to 0.1) (12) 19 (0.2) | 0.1 (0.0 to 0.3) (1) 1 (0.1) | 0.1 (0.0 to 0.3) (2)* 2 (0.2)* | 0.02 (0.0 to 0.1) (2) 4 (0.1) |
| Adjudicated gastrointestinal perforation, IR (95% CI) (n) | 0.1 (0.1 to 0.2) (27) | 0.1 (0.0 to 0.3)(1) | 0.2 (0.1 to 0.5) (6)* | 0.1 (0.0 to 0.2) (7) |
| Adjudicated MACE,† IR (95% CI) (n) | 0.4 (0.3 to 0.5) (85)‡ | 0.3 (0.1 to 0.6) (6) | 0.3 (0.1 to 0.5) (7)* | 0.3 (0.2 to 0.4) (23) |
| DVT,§ IR (95% CI) (n) | 0.2 (0.1 to 0.2) (37) | 0.1 (0.0 to 0.3) (1) | 0.0 (0.0 to 0.2) (1) | 0.1 (0.0 to 0.1) (6) |
| PE,§ IR (95% CI) (n) | 0.1 (0.1 to 0.2) (31) | 0.1 (0.0 to 0.3) (1) | 0.2 (0.0 to 0.4) (4) | 0.1 (0.0 to 0.2) (9) |
*N=1124.
†Composite MACE defined as any myocardial infarction, stroke or cardiovascular death.
‡N=7311.
§Previously reported in Mease et al40 (excludes Study A3921133) and Sandborn et al.44
AE, adverse event; DVT, deep vein thrombosis; HZ, herpes zoster; IR, incidence rate (unique patients with events per 100 patient-years); MACE, major adverse cardiovascular events; N, number of patients in the disease cohort; n, unique number of patients with event (events are counted up to 28 days beyond the last dose or to the data cut-off date, and are included in the calculation of IR); n1, all events, including those occurring outside the 28-day risk period; NMSC, non-melanoma skin cancer; OI, opportunistic infection; PE, pulmonary embolism; PsA, psoriatic arthritis; PsO psoriasis; RA, rheumatoid arthritis; UC, ulcerative colitis.