Table 1.
Tofacitinib IR | Tofacitinib MR | All tofacitinib | ||||
---|---|---|---|---|---|---|
N | % of case reports | N | % of case reports | N | % of case reports | |
PsA | ||||||
Case reports | 2601 | 2425 | 5026 | |||
Sex | ||||||
Male | 710 | 27.3 | 677 | 27.9 | 1387 | 27.6 |
Female | 1850 | 71.1 | 1732 | 71.4 | 3582 | 71.3 |
Not reported | 41 | 1.6 | 16 | 0.7 | 57 | 1.1 |
Age | ||||||
Median (SD) [range], years | 56.0 (12.85) [8.0–90.0] | 56.0 (12.48) [0.50–88.0] | Not available | |||
< 65 years | 1885 | 72.5 | 1866 | 76.9 | 3751 | 74.6 |
≥ 65 years | 575 | 22.1 | 525 | 21.6 | 1100 | 21.9 |
Not reported | 141 | 5.4 | 34 | 1.4 | 175 | 3.5 |
Geographical region | ||||||
North Americaa | 1783 | 68.6 | 2352 | 97.0 | 4135 | 82.3 |
Europeb | 421 | 16.2 | 13 | 0.5 | 434 | 8.6 |
Rest of the worldc | 397 | 15.3 | 60 | 2.5 | 457 | 9.1 |
RA | ||||||
Case reports | 39,744 | 24,148 | 63,892 | |||
Sex | ||||||
Male | 6685 | 16.8 | 4156 | 17.2 | 10,841 | 17.0 |
Female | 32,425 | 81.6 | 19,864 | 82.3 | 52,289 | 81.8 |
Not reported | 634 | 1.6 | 128 | 0.5 | 762 | 1.2 |
Age | ||||||
Median (SD) [range], years | 61.0 (12.63) [0.25–98.0] | 60.0 (12.33) [0.50–97.0] | Not available | |||
< 65 years | 23,175 | 58.3 | 16,030 | 66.4 | 39,205 | 61.4 |
≥ 65 years | 14,631 | 36.8 | 7633 | 31.6 | 22,264 | 34.8 |
Not reported | 1938 | 4.9 | 485 | 2.0 | 2423 | 3.8 |
Geographical region | ||||||
North Americaa | 28,730 | 72.3 | 22,468 | 93.0 | 51,198 | 80.1 |
Europeb | 1903 | 4.8 | 19 | 0.1 | 1922 | 3.0 |
Rest of the worldc | 9111 | 22.9 | 1661 | 6.9 | 10,772 | 16.9 |
IR immediate release, MR modified release, PsA psoriatic arthritis, RA rheumatoid arthritis, SD standard deviation
aIncludes case reports from Canada, Puerto Rico, and the US
bIncludes case reports from Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, and the UK
cIncludes case reports from Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Egypt, Hong Kong, India, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Thailand, Tunisia, and the United Arab Emirates