Table 3.
Safety outcomes by biosimilar status
| Outcome, n (%) | Infliximab-dyyb (n = 870) | Infliximab (n = 2336) | Adjusted HR (95% CI)a | P |
|---|---|---|---|---|
| Any infection | 219 (25.2) | 687 (29.4) | 1.01 (0.86–1.17) | .95 |
| Serious infectionb | 27 (3.1) | 99 (4.2) | 0.83 (0.54–1.26) | .38 |
| Cancer | 11 (1.3) | 49 (2.1) | 0.83 (0.44–1.54) | .55 |
| Acute liver dysfunction | 0 (0) | 3 (0.1) | —c | —c |
| Tuberculosis | 1 (0.1) | 7 (0.3) | 0.59 (0.10–3.55) | .57 |
Abbreviations: CCI, Charlson comorbidity index; CI, confidence interval; ER, emergency room; HR, hazard ratio; IBD, inflammatory bowel disease.
aModels are adjusted for age, gender, race, CCI, IBD disease duration, IBD type, Kaiser Permanente region, IBD-related surgical history, IBD-related ER visit history, IBD-related hospitalization history, budesonide exposure, and corticosteroid exposure.
bSerious infection was defined as an infection requiring hospitalization.
cAnalysis was not performed due to lack of events in infliximab-dyyb group.