Table 3.
Adverse drug reactions in adalimumab-treated RA patients by weekly MTX dose (n = 5494)
| Group 1 (n = 356) | Group 2 (n = 894) | Group 3 (n = 1651) | Group 4 (n = 2005) | Group 5 (n = 588) | |
|---|---|---|---|---|---|
| ADRs | |||||
| n, (%) | 111 (31.2) | 201 (22.5) | 367 (22.2) | 409 (20.4) | 137 (23.3) |
| p value (vs. Group 1)a | NR | 0.0022 | 0.0009 | <0.0001 | 0.0148 |
| p value (vs. Group 2)a | NR | 0.9735 | 0.2816 | 0.6537 | |
| p value (vs. Group 3)a | NR | 0.1822 | 0.6400 | ||
| p value (vs. Group 4)a | NR | 0.1482 | |||
| Serious ADRs | |||||
| n, (%) | 19 (5.3) | 35 (3.9) | 66 (4.0) | 85 (4.2) | 19 (3.2) |
| p value (vs. Group 1)b | NR | 0.2509 | 0.4077 | 0.6596 | 0.2256 |
| p value (vs. Group 2)b | NR | 0.5949 | 0.2897 | 0.8135 | |
| p value (vs. Group 3)b | NR | 0.3933 | 0.4669 | ||
| p value (vs. Group 4)b | NR | 0.2670 | |||
| Infection | |||||
| n, (%) | 34 (9.6) | 57 (6.4) | 97 (5.9) | 140 (7.0) | 61 (10.4) |
| p value (vs. Group 1)c | NR | 0.0831 | 0.0310 | 0.2111 | 0.4343 |
| p value (vs. Group 2)c | NR | 0.7408 | 0.3874 | 0.0032 | |
| p value (vs. Group 3)c | NR | 0.1480 | 0.0003 | ||
| p value (vs. Group 4)c | NR | 0.0080 | |||
| Serious infection | |||||
| n, (%) | 13 (3.7) | 19 (2.1) | 26 (1.6) | 49 (2.4) | 12 (2.0) |
| p value (vs. Group 1)d | NR | 0.2106 | 0.1056 | 0.7095 | 0.5138 |
| p value (vs. Group 2)d | NR | 0.7647 | 0.2170 | 0.5903 | |
| p value (vs. Group 3)d | NR | 0.0683 | 0.3950 | ||
| p value (vs. Group 4)d | NR | 0.2052 | |||
Group 1, >0–<4 mg; group 2, ≥4–<6 mg; group 3, ≥6–<8 mg; group 4, ≥8–<10 mg; group 5, ≥10 mg. aThe analysis was conducted with a stepwise Cox regression analysis, including 5491 patients from the safety population (n = 5494). Group, Steinbrocker’s stage (I and II vs. III and IV), past history of tuberculosis, respiratory comorbidity, cardiovascular comorbidity, and hematologic comorbidity were included in a stepwise Cox regression model. bThe analysis was conducted with a stepwise Cox regression analysis, including 5493 patients from the safety population (n = 5494). Age (per 10 years), sex, comorbidity of respiratory and comorbidity of hematologic were included in a stepwise Cox regression model. cThe analysis was conducted with a stepwise Cox regression analysis, including 5491 patients from the safety population (n = 5494). Group, Steinbrocker’s stage (I and II vs. III and IV), past history of interstitial pneumonia, and cardiovascular comorbidity were included in a stepwise Cox regression model. dThe analysis was conducted with a stepwise Cox regression analysis, including 5400 patients from the safety population (n = 5494). Age (per 10 years), Steinbrocker’s stage (I and II vs. III and IV), past history of interstitial pneumonia, cardiovascular comorbidity, hematologic comorbidity, and prior medication with glucocorticoids (none, >0–≤5 mg/day, >5 mg/day) were included in a stepwise Cox regression model. A weighted average was used to calculate mean MTX dose. ADRs adverse drug reactions, MTX methotrexate, NR not reported, RA rheumatoid arthritis