Hospitalization rate differences among cancer patients on biologics and biosimilars

Autor: Shirisha Reddy, Wilbur Rutter, William Cavers, Elisea Avalos-Reyes, Kjel Andrew Johnson
Rok vydání: 2022
Předmět:
Zdroj: Journal of Clinical Oncology. 40:e13530-e13530
ISSN: 1527-7755
0732-183X
DOI: 10.1200/jco.2022.40.16_suppl.e13530
Popis: e13530 Background: Febrile neutropenia (FN), a severe adverse effect of many cancer treatments, often results in emergency hospitalizations. Granulocyte colony-stimulating factors (G-CSF; filgrastim and pegfilgrastim) have proven efficacy in the prophylaxis of chemotherapy-induced neutropenia and are associated with reducing FN and hospitalizations. Clinical studies have shown that biosimilars are comparable to their originator products; however, no real-world studies on the impact of biosimilar G-CSF on FN hospitalizations exist. We hypothesize that no difference in FN-related hospitalizations between biosimilar and originator biologic G-CSF will occur. Methods: This was a retrospective cohort study of adult patients receiving either biologic G-CSF or biosimilar G-CSF from 5/1/2018 through 4/30/2021. Patients were followed from their initial G-CSF fill during the study period until 30 days following the last dose received. Patients were excluded if they switched exposure groups during the study period or did not maintain eligibility for the duration of follow-up. The primary outcome was FN hospital admission rate between the two groups, defined as any inpatient claims with the primary diagnosis ICD-10 code D70.1 or R50.2. Descriptive statistics and logistic regression were conducted to account for confounding between the groups. Incidence rates were calculated per 1000 person-years of exposure (PY); p-values < 0.05 were considered significant. Results: A total of 13,670 patients met the inclusion criteria, with 6,939 (50.8%) receiving biologic G-CSF. Biosimilar patients were younger (Mean [standard deviation (SD)]: 63.8 [13.4] vs. 65.5 [13.0] p < 0.05), male (40.0% vs. 37.2%; p < 0.05), had more G-CSF claims (Mean [SD]: 5.6 [6.8] vs. 4.5 [4.3]; p < 0.05) and were more likely to utilize a specialty pharmacy (10.1% vs. 4.7%; p < 0.05). Pegfilgrastim was the most common G-CSF medication overall (73.5%); however, filgrastim use was significantly more common in biosimilar patients (43.2% vs. 10.4%; p < 0.05). FN hospitalizations were rare, with 1.1% of patients experiencing an event. No difference in hospitalizations were noted (biosimilars: 1.1%, biologics: 1.0%; p = 0.39). After regression, no factors analyzed were associated with FN-related hospitalizations. Crude FN incidence rates were 45.9 cases per 1000 PY (95% Confidence Interval [CI]: 35.6-56.1 per 1000 PY) among biosimilar patients compared to 37.5 cases per 1000 PY (95% CI: 28.6-46.4 per 1000 PY) among biologic patients, resulting in a rate difference of 8.3 cases per 1000 PY (95% CI: 5.2-22.0 cases per 1000 PY; p = 0.22). Conclusions: In a large real-world analysis, biosimilar G-CSF demonstrated similar effectiveness in preventing FN hospitalization as originator biologic G-CSF agents.
Databáze: OpenAIRE
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