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 baricitinib14 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, days1682.5
Longest exposure, days3405
≥1 AE, n (EAIR)
 Any TEAE3421 (22.6)
 SAE1117 (7.4)
 Temporary study drug interruption due to AE1282 (8.5)*
 Permanent discontinuation of the study drug due to AE704 (4.7)
 Death, n (IR)85 (0.56)
Infections, n (IR)
 Treatment-emergent infections†2590 (17.1)
 Serious infection372 (2.6)
 Herpes zoster422 (3.0)
 Infection leading to death†19 (0.1)
 TB†19 (0.1)
 Opportunistic infection excluding TB69 (0.5)
Malignancy, n (IR)
Malignancy excluding NMSC139 (0.9)
Lymphoma9 (0.06)
NMSC50 (0.3)
Adverse CV events of special interest, n (IR)
MACE‡73 (0.5)
 MI24 (0.2)
 CV death20 (0.1)
 Stroke38 (0.3)
DVT/PE73 (0.5)
 DVT§52 (0.4)
 PE39 (0.3)
GI disorder, n (IR)
GI perforations9 (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.