TABLE 2.
Risk factors for discontinuation of biologic agents in patients with Crohn disease in the discontinuation cohort (univariate analysis)
| First biologic | Second biologic | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Risk factor | Measurement | N | Hazard ratio | 95% CI | P value | N | Hazard ratio | 95% CI | P value |
| Age at biologic initiation | Each additional year of age at biologic initiation | 678 | 0.985 | (0.929–1.043) | 0.5947 | 88 | 0.968 | (0.853–1.098) | 0.6137 |
| Age at diagnosis | Each additional year of age at diagnosis | 675 | 0.974 | (0.925–1.026) | 0.3199 | 88 | 0.977 | (0.864–1.104) | 0.7039 |
| Anemia at biologic initiation | No vs yes | 494 | 0.947 | (0.654–1.373) | 0.7750 | 56 | 0.393 | (0.146–1.056) | 0.0640 |
| Time from diagnosis to start of first biologic | 0 to 3 months vs 3 to 12 months | 675 | 0.986 | (0.627–1.552) | 0.9978 | 81 | 0.693 | (0.222–2.164) | 0.4945 |
| 0 to 3 months vs >12 months | 0.987 | (0.644–1.513) | 1.229 | (0.343–4.407) | |||||
| 3 to 12 months vs >12 months | 1.000 | (0.691–1.448) | 1.773 | (0.664–4.735) | |||||
| BMI z score at biologic initiation | Each additional unit of BMI z-score | 670 | 1.107 | (0.965–1.269) | 0.1459 | 84 | 0.968 | (0.682–1.374) | 0.8566 |
| CRP at biologic initiation | Normal vs elevated | 492 | 1.136 | (0.755–1.709) | 0.5421 | 49 | 0.301 | (0.095–0.953) | 0.0411 |
| Disease phenotype at diagnosis – CD | B1 vs B2/B3 | 644 | 1.468 | (0.811–2.658) | 0.2044 | – | – | – | – |
| ESR at biologic initiation | Normal vs elevated | 452 | 0.812 | (0.527–1.251) | 0.3454 | 46 | 0.574 | (0.148–2.225) | 0.4221 |
| Ethnicity | Hispanic vs non-Hispanic | 469 | 1.679 | (0.678–4.158) | 0.2626 | 54 | 2.405 | (0.532–10.884) | 0.2545 |
| Extent of disease at biologic initiation – macroscopic lower – CD | Colonic-only vs ileocolonic | 523 | 1.612 | (0.911–2.852) | 0.0958 | 71 | 2.145 | (0.744–6.189) | 0.4593 |
| Ileal only vs colonic-only | 0.663 | (0.324–1.359) | 0.265 | (0.031–2.287) | |||||
| Ileal only vs ileocolonic | 1.069 | (0.587–1.948) | 0.569 | (0.073–4.426) | |||||
| None vs colonic-only | 1.849 | (0.617–5.541) | – | – | |||||
| None vs ileal only | 2.788 | (0.916–8.482) | – | – | |||||
| None vs ileocolonic | 2.980 | (1.070–8.300) | – | – | |||||
| Extent of disease at biologic initiation – macroscopic upper distal – CD | No vs yes | 458 | 0.841 | (0.491–1.439) | 0.5264 | 68 | 1.962 | (0.546–7.055) | 0.3017 |
| Extent of disease at biologic initiation – macroscopic upper proximal – CD | No vs yes | 504 | 1.181 | (0.753–1.853) | 0.4687 | 72 | 0.308 | (0.107–0.888) | 0.0292 |
| Hypoalbuminemia at biologic initiation | No vs yes | 473 | 0.976 | (0.573–1.661) | 0.9276 | 55 | 0.387 | (0.137–1.094) | 0.0733 |
| Immunomodulator use within the first 6 months post baseline biologic | No vs yes | 663 | 1.230 | (0.880–1.720) | 0.2251 | 83 | 0.749 | (0.323–1.738) | 0.5010 |
| Extent of disease at diagnosis – macroscopic lower – CD | Colonic-only vs ileocolonic | 638 | 1.939 | (1.279–2.939) | 0.0040 | 77 | 1.297 | (0.461–3.645) | 0.7697 |
| Ileal only vs colonic-only | 0.734 | (0.433–1.246) | 0.536 | (0.108–2.673) | |||||
| Ileal only vs ileocolonic | 1.423 | (0.891–2.275) | 0.696 | (0.150–3.236) | |||||
| None vs colonic-only | 1.330 | (0.587–3.013) | 1.682 | (0.200–14.116) | |||||
| None vs ileal only | 1.811 | (0.780–4.204) | 3.135 | (0.283–34.681) | |||||
| None vs ileocolonic | 2.578 | (1.181–5.628) | 2.181 | (0.274–17.380) | |||||
| Perianal disease at biologic initiation | No vs yes | 623 | 1.286 | (0.859–1.927) | 0.2217 | 82 | 0.777 | (0.316–1.910) | 0.5828 |
| PGA at biologic initiation | Mild vs moderate | 659 | 0.702 | (0.483–1.020) | 0.1505 | 85 | 0.672 | (0.258–1.750) | 0.1818 |
| Mild vs severe | 1.201 | (0.434–3.319) | 0.406 | (0.087–1.898) | |||||
| Moderate vs severe | 1.711 | (0.619–4.727) | 0.604 | (0.128–2.859) | |||||
| Quiescent vs mild | 1.511 | (0.956–2.386) | 0.418 | (0.113–1.546) | |||||
| Quiescent vs moderate | 1.060 | (0.672–1.671) | 0.281 | (0.074–1.062) | |||||
| Quiescent vs severe | 1.814 | (0.636–5.173) | 0.170 | (0.028–1.024) | |||||
| Prednisone or methylprednisolone usage at biologic initiation | No vs yes | 678 | 0.670 | (0.482–0.931) | 0.0170 | 88 | 1.157 | (0.424–3.154) | 0.7757 |
| Race | Black vs non-Black | 611 | 1.193 | (0.697–2.042) | 0.5204 | 80 | 1.349 | (0.390–4.671) | 0.6362 |
| Short PCDAI | Each additional sPCDAI score unit | 472 | 1.011 | (1.001–1.022) | 0.0320 | 72 | 1.020 | (0.997–1.043) | 0.0854 |
| Albumin at biologic initiation | Each additional unit of albumin | 473 | 0.969 | (0.683–1.373) | 0.8578 | 55 | 0.368 | (0.181–0.748) | 0.0058 |
| ESR at biologic initiation | Each additional hematocrit unit | 452 | 1.005 | (0.996–1.014) | 0.2631 | 46 | 1.017 | (0.987–1.047) | 0.2627 |
| Hematocrit at biologic initiation | Each additional hematocrit unit | 494 | 0.982 | (0.937–1.030) | 0.4644 | 56 | 0.855 | (0.742–0.986) | 0.0316 |
| Phenotype at biologic initiation – CD | B1 vs B2/B3 | 649 | 1.285 | (0.751–2.198) | 0.3597 | – | – | ||
Bold text indicates statistically significant P values.
BMI = body mass index; CD = Crohn disease; CRP = C-reactive protein; ESR = erythrocyte sedimentation rate; PCDAI = Pediatric Crohn Disease Activity Index; PGA = Physician Global Assessment; sPCDAI = short PCDAI; ULN = upper limit of normal.