Table 1.
Adverse outcomes associated with anemia following ruxolitinib initiation in patients with myelofibrosis.
| Anemic | Non-anemic | |
|---|---|---|
| All-cause death | ||
| No of events/No of patients | 165 / 421 | 121 / 496 |
| IR per 1000 person-years (95% CI) | 146.5 (125.8–170.7) | 92.6 (77.5–110.7) |
| Crude HR (95% CI) | 1.60 (1.27–2.03) | Reference |
| Adjusted HR (95% CI) | ||
| Model 1a | 1.40 (1.11–1.78) | Reference |
| Model 2b | 1.35 (1.06–1.73) | Reference |
| Model 3c | 1.35 (1.06–1.73) | Reference |
| Time to anemia development after ruxolitinib initiation (days)c | ||
| <45 | 1.63 (1.24–2.16) | Reference |
| 45–90 | 1.14 (0.81–1.60) | Reference |
| CVD hospitalization | ||
| No of events/No of patientsd | 77 / 383 | 75 / 489 |
| IR per 1000 person-years (95% CI) | 82.7 (66.1–103.3) | 64.1 (51.1–80.3) |
| Crude HR (95% CI) | 1.30 (0.94–1.78) | Reference |
| Adjusted HR (95% CI) | ||
| Model 1a | 1.19 (0.86–1.65) | Reference |
| Model 2b | 1.20 (0.87–1.66) | Reference |
| Model 3c | 1.20 (0.86–1.66) | Reference |
| SubHR (95% CI)c,e | 1.16 (0.84–1.62) | Reference |
| Time to anemia development after ruxolitinib initiation (days)c | ||
| <45 | 1.34 (0.91–1.98) | Reference |
| 45–90 | 1.12 (0.73–1.73) | Reference |
| Serious infection | ||
| No of events/No of patientsd | 129 / 391 | 102 / 487 |
| IR per 1000 person-years (95% CI) | 147.0 (123.7–174.6) | 89.6 (73.8–108.8) |
| Crude HR (95% CI) | 1.64 (1.26–2.12) | Reference |
| Adjusted HR (95% CI) | ||
| Model 1a | 1.49 (1.14–1.95) | Reference |
| Model 2b | 1.53 (1.17–2.00) | Reference |
| Model 3c | 1.56 (1.19–2.05) | Reference |
| SubHR (95% CI)c,e | 1.46 (1.11–1.92) | Reference |
| Time to anemia development after ruxolitinib initiation (days)c | ||
| <45 | 1.97 (1.45–2.67) | Reference |
| 45–90 | 1.12 (0.77–1.63) | Reference |
| AML | ||
| No of events / No of patients | 37 / 421 | 42 / 496 |
| IR per 1000 person-years (95% CI) | 33.6 (24.3–46.3) | 32.8 (24.2–44.4) |
| Crude HR (95% CI) | 1.01 (0.65–1.57) | Reference |
| Adjusted HR (95% CI) | ||
| Model 1a | 1.14 (0.72–1.79) | Reference |
| Model 2b | 1.13 (0.72–1.79) | Reference |
| Model 3c | 1.07 (0.68–1.70) | Reference |
| SubHR (95% CI)c,e | 1.04 (0.64–1.68) | Reference |
| Time to anemia development after ruxolitinib initiation (days)c | ||
| <45 | 1.41 (0.84–2.37) | Reference |
| 45–90 | 0.66 (0.33–1.33) | Reference |
IR incidence rate, HR hazard ratio, CI confidence intervals, CVD cardiovascular diseases, AML acute myeloid leukemia.
aModel 1: Adjusted for age and sex.
bModel 2: Adjusted for age, sex, number of hospitalizations, duration of myelofibrosis, Charlson comorbidity index, and health insurance type.
cModel 3: Adjusted for age, sex, number of hospitalizations, duration of myelofibrosis, Charlson comorbidity index, health insurance type, cancer, chronic kidney disease, depression, diabetes, dyslipidemia, hypertension, splenomegaly, and hydroxyurea use.
dWhen assessing CVD hospitalization, patients with CVD hospitalization within 90 days after ruxolitinib initiation were excluded. Similarly, when assessing serious infection, patients with serious infection within 90 days after ruxolitinib initiation were excluded.
eSub-hazard ratios were estimated using all-cause death as a competing risk.