Table 1.
Characteristics of JAK inhibitor use cases in JADER reports
| Totala | Tofacitinib | Ruxolitinib | Baricitinib | Peficitinib | Upadacitinib | Filgotinib | Abrocitinib | |
|---|---|---|---|---|---|---|---|---|
| Approval year | – | 2013 | 2014 | 2017 | 2019 | 2020 | 2020 | 2021 |
| Cases (n) | 6631 | 2431 | 1513 | 1338 | 651 | 580 | 233 | 30 |
| Report type | ||||||||
| Report from study | 3828 (57.7) | 1357 (55.8) | 939 (62.1) | 772 (57.7) | 529 (81.3) | 258 (44.5) | 68 (29.2) | 5 (16.7) |
| Spontaneous | 2795 (42.2) | 1070 (44.0) | 574 (37.9) | 565 (42.2) | 121 (18.6) | 320 (55.2) | 165 (70.8) | 25 (83.3) |
| Other or unknown | 8 (0.1) | 4 (0.2) | 0 (0.0) | 1 (0.07) | 1 (0.2) | 2 (0.3) | 0 (0.0) | 0 (0.0) |
| Age | ||||||||
| < 10 | 16 (0.2) | 4 (0.2) | 12 (0.8) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| ≥ 10 to < 20 | 63 (1.0) | 18 (0.7) | 11 (0.7) | 0 (0.0) | 2 (0.3) | 22 (3.8) | 2 (0.9) | 11 (36.7) |
| ≥ 20 to < 30 | 98 (1.5) | 68 (2.8) | 3 (0.2) | 11 (0.8) | 2 (0.3) | 10 (1.7) | 1 (0.4) | 3 (10.0) |
| ≥ 30 to < 40 | 132 (2.0) | 65 (2.7) | 12 (0.8) | 24 (1.8) | 5 (0.8) | 21 (3.6) | 1 (0.4) | 5 (16.7) |
| ≥ 40 to < 50 | 339 (5.1) | 153 (6.3) | 44 (2.9) | 77 (5.8) | 24 (3.7) | 30 (5.2) | 11 (4.7) | 2 (6.7) |
| ≥ 50 to < 60 | 722 (10.9) | 294 (12.1) | 123 (8.1) | 171 (12.8) | 56 (8.6) | 63 (10.9) | 29 (12.4) | 3 (10.0) |
| ≥ 60 to < 70 | 1460 (22.0) | 614 (25.3) | 325 (21.5) | 287 (21.5) | 112 (17.2) | 105 (18.1) | 39 (16.7) | 0 (0.0) |
| ≥ 70 to < 80 | 2189 (33.0) | 724 (29.8) | 575 (38.0) | 437 (32.7) | 231 (35.5) | 202 (34.8) | 80 (34.3) | 1 (3.3) |
| ≥ 80 to < 90 | 1024 (15.4) | 303 (12.5) | 193 (0.13) | 219 (16.4) | 189 (29.0) | 97 (16.7) | 52 (22.3) | 2 (6.7) |
| ≥ 90 to < 100 | 62 (0.9) | 16 (0.7) | 4 (0.3) | 20 (1.5) | 13 (2.0) | 10 (1.7) | 1 (0.4) | 0 (0.0) |
| Youth | 1 (0.02) | 1 (0.04) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Adult | 63 (1.0) | 8 (0.3) | 34 (2.2) | 16 (1.2) | 0 (0.0) | 2 (0.3) | 4 (1.7) | 3 (10.0) |
| Elderly | 100 (1.5) | 11 (0.5) | 74 (4.9) | 2 (0.1) | 5 (0.8) | 3 (0.5) | 5 (2.1) | 0 (0.0) |
| Unknown | 362 (5.5) | 152 (6.3) | 103 (6.8) | 74 (5.5) | 12 (1.8) | 15 (2.6) | 8 (3.4) | 0 (0.0) |
| Sex | ||||||||
| Female | 4032 (60.8) | 1578 (67.8) | 644 (42.6) | 877 (70.0) | 482 (74.0) | 381 (66.8) | 168 (72.1) | 10 (33.3) |
| Male | 2300 (34.7) | 749 (32.2) | 795 (52.5) | 366 (29.2) | 164 (25.2) | 188 (33.0) | 53 (22.7) | 18 (60.0) |
| Unknown or missing | 299 (4.5) | 0 (0.0) | 74 (4.9) | 9 (0.7) | 5 (0.8) | 1 (0.2) | 12 (5.2) | 2 (6.7) |
| Disease or reason for use | ||||||||
| Rheumatoid arthritis | 1914b (78.7) | – | 1076 (80.4) | 630 (96.8) | 438 (75.4) | 198 (85.0) | – | |
| Ulcerative colitis | 287 (11.8) | – | – | – | 46 (7.9) | 28 (12.0) | – | |
| Myelofibrosis | – | 1115 (73.7) | – | – | – | – | – | |
| Polycythemia vera | – | 281 (18.6) | – | – | – | – | – | |
| Graft-versus-host disease | – | 34 (2.2) | – | – | – | – | – | |
| Atopic dermatitis | – | – | 43 (3.2) | – | 55 (9.5) | – | 26 (86.7) | |
| COVID-19 | – | – | 153 (11.4) | – | – | – | – | |
| Alopecia areata | – | – | 7c (0.5) | – | – | – | – | |
| Psoriatic arthritis | – | – | – | – | 17 (2.9) | – | – | |
| Spondyloarthritis axialis | – | – | – | – | 0 | – | – | |
| Ankylosing spondylitis | – | – | – | – | 5 (0.9) | – | – | |
| Crohn’s disease | – | – | – | – | 4 (0.7) | – | – | |
| Other | 69 (2.8) | 54 (3.6) | 7 (0.5) | 2 (0.3) | 4 (0.7) | 0 | 0 | |
| Unknown | 161 (6.6) | 29 (1.9) | 52 (3.9) | 19 (2.9) | 12 (2.1) | 7 (3.0) | 4 (13.3) | |
Results as number and percentage, unless otherwise specified. In the Disease or reason for use section, a hyphenated column indicates that the drug is not indicated for use in Japan
JAK Janus kinase, JADER Japanese Adverse Drug Event Report database, COVID-19 coronavirus disease 2019
aValues that include multiple JAK inhibitor use cases
bIncluding two cases of rheumatoid arthritis and ulcerative colitis
cIncluding one case of alopecia areata combined with atopic dermatitis