Table 2.
TB IRs for tofacitinib patients by background country IRs* (phase II, III and LTE studies)
| TB cases with tofacitinib (n) | Tofacitinib exposure (patient-years) | Crude TB IR † (95% CI) | |
|---|---|---|---|
| Low‡ (0.01) | 1 | 4852.3 | 0.02 (0.003 to 0.15) |
| Medium§ (≥0.01 and ≤0.05) | 4 | 5020.5 | 0.08 (0.03 to 0.21) |
| High¶ (>0.05) | 21 | 2791.1 | 0.75 (0.49 to 1.15) |
*TB background country IR categories from WHO, 2011 report for year 2010.26
†Crude incidence calculated TB cases per 100 patient-years.
‡Low TB incidence region (total study enrolment, n=2213); the USA (n=1098), Czech Republic (n=378), Germany (n=238), Slovakia (n=126), Australia (n=114), Canada (n=103), Austria (n=36), Italy (n=28), Sweden (n=17), Finland (n=16), Greece (n=15), Belgium (n=13), France (n=10), Denmark (n=9), New Zealand (n=9) Ireland (n=3).
§Medium TB incidence region (total study enrolment, n=2132); Japan (n=556), Brazil (n=306), Mexico (n=259), Poland (n=254), Chile (n=174), Bulgaria (n=169), Spain (n=128), Colombia (n=120), Argentina (n=61), Croatia (n=27), Hungary (n=27), the UK (n=17), Costa Rica (n=16), Venezuela (n=7), Bosnia-Herzegovina (n=6), Turkey (n=5).
¶High TB IR (total study enrolment, n=1326); Korea (n=284), Ukraine (n=227), China (n=213), India (n=194), Russia (n=149), Thailand (n=63), Philippines (n=61), Malaysia (n=46), Taiwan (n=36), Dominican-Republic (n=27), Peru (n=14), Romania (n=12).
IR, incidence rate; LTE, long-term extension; TB, tuberculosis.