Bleeding-related episodes (BRE) in patients with immune thrombocytopenia (ITP) receiving eltrombopag (EPAG ) or romiplostim (ROMI): Real world evidence from 26 us institutions

Objectives: To examine burden of BREs in ITP patients treated with EPAG or ROMI. Methods: We investigated BREs, a complication of ITP that leads to significant morbidity and mortality, using a syndicated electronic medical records network that contains records for inpatient and outpatient services and procedures, diagnoses, adverse events (AEs), prescriptions and labs for > 27 million patients from 26 US hospital institutions. Adult patients diagnosed with primary ITP and treated with EPAG or ROMI with prior steroid treatment were included. Patients with secondary ITP, history of HBV, HCV, HIV, malignancy, severe aplastic anemia, myelodysplastic syndrome, myelofibrosis and splenectomy were excluded. BREs were identified based on bleeding codes [BE] and/or uses of rescue therapy [RES] (intravenous (IV) immunoglobulin administration, IV steroid administration, or platelet transfusion (PT) using a combination of diagnosis, procedure, and medication codes. BREs requiring PT were considered severe (sBRE). BREs after initiation of EPAG or ROMI were compared using Z-tests (two-tailed α = 0.05). Results: 140 patients were identified: EPAG (90) or ROMI (50). Mean age (standard deviation) was similar: EPAG 53 (21) /ROMI 56 (23). Liver function tests ALT (EPAG 16.50 (7.97) / ROMI 16.00 (5.96) U/L) , AST (

EPAG:

18.75 (1.79) / ROMI 18.00 (4.85) U/L), and mean platelet volume (EPAG 10.67

/ ROMI:

10.60 fL) were also similar across cohorts. The BREs identified through RES were not significantly different between ROMI and EPAG (20 vs 22%, p= 0.759), while those identified through BE were significantly higher in ROMI vs. EPAG (40 vs 22%, p= 0.026). Conclusions: This retrospective RWE study emphasizes the significant burden of BREs in ITP patients despite treatment which aims to prevent these episodes. BRE rates identified as BE after controlling for confounding, were significantly higher in ROMI-treated patients as compared to EPAG-treated patients.