Table 3.
Factors Affecting the Safety of Adalimumab Identified by Multiple Logistic Regression Analysis for ADRs and Serious ADRs (n=1,184)
| Baseline factor | No. of patients evaluated | OR (95% CI) |
|---|---|---|
| Age (yr) | ||
| < 15 | 14 | 2.00 (0.58–6.83) |
| 15 to < 65 | 1,058 | NA |
| ≥ 65 | 112 | 0.91 (0.55–1.50) |
| Sex | ||
| Male | 659 | NA |
| Female | 525 | 1.40 (1.03–1.90) |
| Disease duration (yr) | ||
| <2 | 261 | 0.82 (0.55–1.22) |
| 2 to < 10 | 579 | NA |
| ≥ 10 | 344 | 0.84 (0.59–1.20) |
| Comorbidity | ||
| No | 672 | NA |
| Yes | 512 | 1.81 (1.33–2.46) |
| History of allergy | ||
| No | 915 | NA |
| Yes | 269 | 1.68 (1.20–2.34) |
| History of smoking | ||
| No | 906 | NA |
| Yes | 278 | 1.51 (1.07–2.14) |
| Prior use of biologics | ||
| No | 873 | NA |
| Yes | 311 | 0.82 (0.58–1.17) |
| Prior use of tacrolimus/cyclosporine | ||
| No | 966 | NA |
| Yes | 218 | 1.41 (0.98–2.02) |
| Concomitant use of corticosteroid | ||
| No | 647 | NA |
| Yes | 537 | 1.14 (0.84–1.55) |
| Concomitant use of immunomodulator | ||
| No | 665 | NA |
| Yes | 519 | 1.10 (0.81–1.48) |
| Partial Mayo score | ||
| 0 to < 3 | 150 | 0.90 (0.56–1.47) |
| 3 to < 6 | 461 | 1.09 (0.80–1.50) |
| 6 to ≤ 9 | 573 | NA |
ADR, adverse drug reaction; OR, odds ratio; CI, confidence interval; NA, not applicable (control group in each baseline factor category; therefore, no values).