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Severe pegaspargase hypersensitivity reaction rates (grade ?3) with intravenous infusion vs. intramuscular injection: analysis of 54,280 doses administered to 16,534 patients on children's oncology group (COG) clinical trials.

ABSTRACT: PEGylated asparaginase (pegaspargase) can be administered via intramuscular (IM) injection or intravenous (IV) infusion with a hypersensitivity reaction (HSR) incidence ranging 3-41%. We evaluated grade ?3 HSRs when given IM vs. IV on six Children's Oncology Group (COG) leukemia trials (2003-2015) to determine differences in HSR rates. 54,280 doses were administered to 16,534 patients. Considering all doses of pegaspargase during induction, consolidation, and delayed intensification, grade ?3 HSR rate with IM injection was 5.4% (n?=?482/8981) compared to 3.2% for IV (n?=?245/7553) (p?

SUBMITTER: Burke MJ

PROVIDER: S-EPMC5940583 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Severe pegaspargase hypersensitivity reaction rates (grade ≥3) with intravenous infusion vs. intramuscular injection: analysis of 54,280 doses administered to 16,534 patients on children's oncology group (COG) clinical trials.

Burke Michael J MJ Devidas Meenakshi M Maloney Kelly K Angiolillo Anne A Schore Reuven R Dunsmore Kimberly K Larsen Eric E Mattano Len A LA Salzer Wanda W Winter Stuart S SS Carroll William W Winick Naomi J NJ Loh Mignon L ML Raetz Elizabeth E Hunger Stephen P SP Bleyer Archie A

Leukemia & lymphoma 20171108 7

PEGylated asparaginase (pegaspargase) can be administered via intramuscular (IM) injection or intravenous (IV) infusion with a hypersensitivity reaction (HSR) incidence ranging 3-41%. We evaluated grade ≥3 HSRs when given IM vs. IV on six Children's Oncology Group (COG) leukemia trials (2003-2015) to determine differences in HSR rates. 54,280 doses were administered to 16,534 patients. Considering all doses of pegaspargase during induction, consolidation, and delayed intensification, grade ≥3 HS ...[more]

PMID: 29115886

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Project description:Introduction/objectivesMultiple modes of administration are available for systemic lupus erythematosus (SLE) treatments. This study examined patient and physician characteristics associated with the choice of weekly subcutaneous (SC) injection or monthly intravenous (IV) infusion for an unspecified SLE treatment.MethodsThis was a cross-sectional, US web-based survey using a direct elicitation, stated-preference methodology (HO-16-16706). Two hundred patients and 200 physicians were asked to choose between IV or SC administration in a hypothetical scenario. Pairwise and multivariate analyses estimated the odds ratio (OR) for the likelihood of choosing SC over IV for respondent characteristics.ResultsAmong patients, taking non-steroidal anti-inflammatory drugs increased the likelihood of choosing SC injection (OR 3.884), whilst having SLE-related skin problems, a fear of needles or self-injection, and never needing help around the house decreased the likelihood (OR 0.28, 0.13, 0.12, respectively; all p???0.05). Among physicians, >?95% recommended SC injection for patients who live or work far from an infusion center, prefer SC administration, and never or rarely miss medication doses. Physician characteristics including age and treatment practice also influenced choice.ConclusionsPatient and physician characteristics influence choice of SC versus IV therapy for SLE. These findings might inform shared decision-making, which could lead to improved patient outcomes. Key Points • Data regarding patient and physician preference for different modes of administration of SLE therapy are sparse. • This cross-sectional, US web-based study showed that patient and physician characteristics influence choice of SC versus IV therapy for SLE. • A degree of disconnect exists between how factors influence patients' choice and how those characteristics influence physicians' choice of SLE treatment mode of administration. • The findings from this study might inform shared decision-making, which could improve alignment between treatment choice and patient preferences, treatment satisfaction, adherence, and improved patient outcomes.

Dataset Information

Severe pegaspargase hypersensitivity reaction rates (grade ?3) with intravenous infusion vs. intramuscular injection: analysis of 54,280 doses administered to 16,534 patients on children's oncology group (COG) clinical trials.

Publications

Severe pegaspargase hypersensitivity reaction rates (grade ≥3) with intravenous infusion vs. intramuscular injection: analysis of 54,280 doses administered to 16,534 patients on children's oncology group (COG) clinical trials.

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