Table 1 Characteristics of spontaneous reports of MTX-related ADRs by organ affected
Characteristics | Total | ADR on kidneys | ADR on liver | |||
|---|---|---|---|---|---|---|
(n = 10319) | (n = 365)1 | (n = 1082)1 | ||||
Age, in years | (n = 6680) | (n = 247) | (n = 599) | |||
Mean (SD) | 62.3 (14.2) | 65.8 (13.7) | 59.6 (13.9) | |||
Median (Q1-Q3) | 64.0 (54.0–72.0) | 67.0 (59.0–76.0) | 60.0 (51.0–68.0) | |||
Age groups, in years | (n = 6686) | (n = 247) | (n = 599) | |||
0–17 | 33 (0.5%) | 1 (0.4%) | 2 (0.3%) | |||
18–39 | 425 (6.4%) | 8 (3.2%) | 46 (7.7%) | |||
40–59 | 2091 (31.3%) | 61 (24.7%) | 241 (40.2%) | |||
60–79 | 3496 (52.3%) | 141 (57.1%) | 262 (43.7%) | |||
80+ | 641 (9.6%) | 36 (14.6%) | 48 (8.0%) | |||
Sex | (n = 10155) | (n = 356) | (n = 1070) | |||
Female | 7371 (72.6%) | 246 (69.1%) | 767 (71.7%) | |||
Male | 2784 (27.4%) | 110 (30.9%) | 303 (28.3%) | |||
Comorbidity | (n = 5486) | (n = 262) | (n = 483) | |||
Cancerous | 548 (10.0%) | 29 (11.1%) | 42 (8.7%) | |||
Comedication | (n = 10319) | (n = 365) | (n = 1082) | |||
Any comedication | 7218 (69.9%) | 302 (82.7%) | 694 (64.1%) | |||
Any NSAID2 | 1527 (14.8%) | 86 (23.6%) | 171 (15.8%) | |||
Most common groups | ||||||
Propionic acid derivates (M01AE) | 522 (5.1%) | 40 (11.0%) | 64 (5.9%) | |||
Acetic acid derivates and related substances (M01AB) | 494 (4.8%) | 32 (8.8%) | 54 (5.0%) | |||
Coxibs (M01AH) | 243 (2.4%) | 6 (1.6%) | 22 (2.0%) | |||
Oxicam (M01AC) | 130 (1.3%) | 7 (1.9%) | 16 (1.5%) | |||
Most common agents | ||||||
Diclofenac | 356 (3.4%) | 23 (6.3%) | 43 (4.0%) | |||
Naproxen | 216 (2.1%) | 15 (4.1%) | 19 (1.8%) | |||
Ibuprofen | 207 (2.0%) | 16 (4.4%) | 30 (2.8%) | |||
Acetylsalicylic acid | 135 (1.3%) | 3 (0.8%) | 13 (1.2%) | |||
Celecoxib | 122 (1.2%) | 4 (1.1%) | 12 (1.1%) | |||
Acetaminophen | 813 (7.9%) | 50 (13.7%) | 96 (8.9%) | |||
Metamizole | 121 (1.2%) | 25 (6.8%) | 23 (2.1%) | |||
Non-MTX DMARD | 4452 (43.1%) | 149 (40.8%) | 387 (35.8%) | |||
bDMARD | 3379 (32.7%) | 98 (26.8%) | 253 (23.4%) | |||
csDMARD | 1361 (13.2%) | 67 (18.4%) | 160 (14.8%) | |||
tsDMARD | 210 (2.0%) | 10 (2.7%) | 14 (1.3%) | |||
Corticosteroids | 2947 (28.6%) | 139 (38.1%) | 266 (24.6%) | |||
Folic acid | 2432 (23.6%) | 115 (31.5%) | 233 (21.5%) | |||
MTX use | ||||||
Route | (n = 7863) | (n = 255) | (n = 840) | |||
Oral | 4633 (58.9%) | 177 (69.4%) | 575 (68.5%) | |||
Subcutaneous/Subdermal | 2152 (27.4%) | 47 (18.4%) | 182 (21.7%) | |||
Duration in months | (n = 6269) | (n = 223) | (n = 783) | |||
Mean (SD) | 40.3 (59.5) | 45.9 (65.0) | 30.7 (51.8) | |||
Median (Q1-Q3) | 13.2 (3.0-54.5) | 16.2 (3.1–72.0) | 9.9 (2.8–34.3) | |||
ADR | (n = 10319) | (n = 365) | (n = 1082) | |||
On kidneys and liver | 67 (0.7%) | 67 (18.4%) | 67 (6.2%) | |||
Outcome | (n = 9906) | (n = 365) | (n = 1042) | |||
Fatal | 738 (7.5%) | 77 (21.1%) | 60 (5.8%) | |||