Table 1.
Safety summary among patients with RA treated with at least one dose of baricitinib (All-bari-RA analysis set)
| All-bari-RA (N=3770) |
|
| Exposure | |
| Total patient-years of exposure to baricitinib | 14 744.4 |
| Total patient-years (including follow-up period) | 15 114.1 |
| Number of patients with ≥52 weeks, n (%) | 2961 (78.5) |
| Number of patients with ≥104 weeks, n (%) | 2519 (66.8) |
| Number of patients with ≥208 weeks, n (%) | 2093 (55.5) |
| Number of patients with ≥260 weeks, n (%) | 1775 (47.1) |
| Median duration, days | 1682.5 |
| Longest exposure, days | 3405 |
| ≥1 AE, n (EAIR) | |
| Any TEAE | 3421 (22.6) |
| SAE | 1117 (7.4) |
| Temporary study drug interruption due to AE | 1282 (8.5)* |
| Permanent discontinuation of the study drug due to AE | 704 (4.7) |
| Death, n (IR) | 85 (0.56) |
| Infections, n (IR) | |
| Treatment-emergent infections† | 2590 (17.1) |
| Serious infection | 372 (2.6) |
| Herpes zoster | 422 (3.0) |
| Infection leading to death† | 19 (0.1) |
| TB† | 19 (0.1) |
| Opportunistic infection excluding TB | 69 (0.5) |
| Malignancy, n (IR) | |
| Malignancy excluding NMSC | 139 (0.9) |
| Lymphoma | 9 (0.06) |
| NMSC | 50 (0.3) |
| Adverse CV events of special interest, n (IR) | |
| MACE‡ | 73 (0.5) |
| MI | 24 (0.2) |
| CV death | 20 (0.1) |
| Stroke | 38 (0.3) |
| DVT/PE | 73 (0.5) |
| DVT§ | 52 (0.4) |
| PE | 39 (0.3) |
| GI disorder, n (IR) | |
| GI perforations | 9 (0.06) |
*Some studies did not collect temporary interruption of study drug.
†Used EAIR per 100 PY (patient exposure not censored at the event).
‡Potential CV adverse events from the phase III and LTE trials, identified by investigators or according to a predefined list of event terms, were adjudicated by an independent, external Clinical Endpoint Committee that remained blinded to treatment assignments.
§DVT includes distal events below the knee.
AE, adverse events; bari, baricitinib; CV, cardiovascular; DVT, deep vein thrombosis; EAIR, exposure-adjusted incidence rate; GI, gastrointestinal; IR, incidence rate; LTE, long-term extension; MACE, major adverse cardiovascular events; MI, myocardial infarction; N, number of patients in the analysis set; n, number of patients in the specified category; NMSC, non-melanoma skin cancer; PE, pulmonary embolism; PY, patient-years; RA, rheumatoid arthritis; SAE, serious adverse event; TB, tuberculosis; TEAE, treatment-emergent adverse event.