Adverse event rates and economic burden associated with purine nucleoside analogs in patients with hairy cell leukemia : a US population-retrospective claims analysis
BACKGROUND: Purine nucleoside analogs (PNAs) are the recommended first-line treatment for patients with hairy cell leukemia (HCL), but they are associated with adverse events (AEs). Due to a lack of real-world evidence regarding AEs that are associated with PNAs, we used commercial data to assess AE rates, AE-related health care resource utilization (HCRU), and costs among PNA-treated patients with HCL. Adults aged ≥18 years with ≥2 claims for HCL ≥30 days apart from 1 January 2006 through 31 December 2015 were included. Included patients had ≥1 claim for HCL therapy (cladribine ± rituximab or pentostatin ± rituximab [index date: first claim date]) and continuous enrollment for a ≥ 6-month baseline and ≥ 12-month follow-up period. Patient sub-cohorts were based on the occurrence of myelosuppression and opportunistic infections (OIs). Generalized linear models were used to compare HCRU and costs.
RESULTS: In total, 647 PNA-treated patients were identified (mean age: 57.1 years). Myelosuppression and OI incidence were 461 and 42 per 1000 patient-years, respectively. Adjusted results indicated that those with myelosuppression had higher rates of hospitalization (47.4% vs 12.4%; P < .0001) and incurred higher mean inpatient costs ($23,517 vs $12,729; P = .011) and total costs ($57,325 vs $34,733; P = .001) as compared with those without myelosuppression. Similarly, patients with OIs had higher rates of hospitalization (53.8% vs 30.8%; P = .025) and incurred higher mean inpatient costs ($21,494 vs $11,229; P < .0001) as compared with those without OIs.
CONCLUSIONS: PNA therapy is highly effective but associated with significant toxicities that increase costs; these findings indicate a need for therapies with improved toxicity profiles and better risk stratification of patients at risk of developing myelosuppression and OIs.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2020 |
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| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:15 |
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| Enthalten in: |
Orphanet journal of rare diseases - 15(2020), 1 vom: 13. Feb., Seite 47 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Epperla, Narendranath [VerfasserIn] |
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| Links: |
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| Themen: |
Adverse events |
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| Anmerkungen: |
Date Completed 18.06.2021 Date Revised 18.06.2021 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1186/s13023-020-1325-9 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM306487195 |
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| 100 | 1 | |a Epperla, Narendranath |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Adverse event rates and economic burden associated with purine nucleoside analogs in patients with hairy cell leukemia |b a US population-retrospective claims analysis |
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| 500 | |a Date Revised 18.06.2021 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Purine nucleoside analogs (PNAs) are the recommended first-line treatment for patients with hairy cell leukemia (HCL), but they are associated with adverse events (AEs). Due to a lack of real-world evidence regarding AEs that are associated with PNAs, we used commercial data to assess AE rates, AE-related health care resource utilization (HCRU), and costs among PNA-treated patients with HCL. Adults aged ≥18 years with ≥2 claims for HCL ≥30 days apart from 1 January 2006 through 31 December 2015 were included. Included patients had ≥1 claim for HCL therapy (cladribine ± rituximab or pentostatin ± rituximab [index date: first claim date]) and continuous enrollment for a ≥ 6-month baseline and ≥ 12-month follow-up period. Patient sub-cohorts were based on the occurrence of myelosuppression and opportunistic infections (OIs). Generalized linear models were used to compare HCRU and costs | ||
| 520 | |a RESULTS: In total, 647 PNA-treated patients were identified (mean age: 57.1 years). Myelosuppression and OI incidence were 461 and 42 per 1000 patient-years, respectively. Adjusted results indicated that those with myelosuppression had higher rates of hospitalization (47.4% vs 12.4%; P < .0001) and incurred higher mean inpatient costs ($23,517 vs $12,729; P = .011) and total costs ($57,325 vs $34,733; P = .001) as compared with those without myelosuppression. Similarly, patients with OIs had higher rates of hospitalization (53.8% vs 30.8%; P = .025) and incurred higher mean inpatient costs ($21,494 vs $11,229; P < .0001) as compared with those without OIs | ||
| 520 | |a CONCLUSIONS: PNA therapy is highly effective but associated with significant toxicities that increase costs; these findings indicate a need for therapies with improved toxicity profiles and better risk stratification of patients at risk of developing myelosuppression and OIs | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Adverse events | |
| 650 | 4 | |a Hairy cell leukemia | |
| 650 | 4 | |a Myelosuppression | |
| 650 | 4 | |a Purine nucleoside analogs | |
| 650 | 7 | |a Nucleosides |2 NLM | |
| 650 | 7 | |a Purine Nucleosides |2 NLM | |
| 700 | 1 | |a Pavilack, Melissa |e verfasserin |4 aut | |
| 700 | 1 | |a Olufade, Temitope |e verfasserin |4 aut | |
| 700 | 1 | |a Bashyal, Richa |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jieni |e verfasserin |4 aut | |
| 700 | 1 | |a Kabadi, Shaum M |e verfasserin |4 aut | |
| 700 | 1 | |a Yuce, Huseyin |e verfasserin |4 aut | |
| 700 | 1 | |a Andritsos, Leslie |e verfasserin |4 aut | |
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