A Retrospective Study of Medicare claim data shows patients treated with Voraxaze® had shorter hospitalizations and lower mortality

BTG plc (LSE: BTG), the global healthcare company, today announced the publication of data showing that cancer patients with presumed methotrexate toxicity treated with Voraxaze® (glucarpidase) had sh

BTG plc (LSE: BTG), the global healthcare company, today announced the publication of data showing that cancer patients with presumed methotrexate toxicity treated with Voraxaze® (glucarpidase) had shorter hospital stays, lower in-patient mortality, and lower 90-day mortality than those treated with conventional treatment. The study, based on a retrospective review of Medicare claim data, was published in the journal ClinicoEconomics and Outcomes Research.

“This is the first comparison of patient outcomes associated with Voraxaze® relative to outcomes experienced by similar patients not treated with Voraxaze®,” said Christon Hill, Vice President of R&D for BTG Pharmaceuticals. “Together with existing clinical data and the inclusion of Voraxaze® in consensus treatment guidelines, this review of Medicare patient data adds useful evidence for physicians and payers treating cancer patients.”

Researchers used 2010-2017 Medicare claim data to identify patients with select lymphomas or leukemia, inpatient chemotherapy, and treatment with Voraxaze®. Hospital length of stay, mortality, and readmission rates were compared between these patients and those treated with alternative therapies. Researchers conducted inverse probability treatment weighting using propensity scores to control for between-group differences in patient characteristics and to make the groups comparable. An exploratory analysis also compared outcomes between patients who received Voraxaze® within 3 days of admission to the hospital and those who received it after 3 days.

Results:

Among patients who received Voraxaze® the average length of stay was 14.7 days, 4.0 of which were spent in the intensive care unit (ICU). Patients in the non-glucarpidase group, with or without dialysis, spent an average of 21.9 days in hospital (p=0.025) and 8.3 days in the ICU (p=0.056).

Inpatient mortality among Voraxaze® patients was 3.3% and 30-day and 90-day mortality 13.3% and 16.7%, respectively. Patients in the non-glucarpidase group, with or without dialysis, had a higher inpatient mortality rate of 20.8% (p=0.024). There was no statistically significant difference between groups in terms of 30-day and 90-day mortality.

Patients in the non-glucarpidase group treated with dialysis had an even longer length of stay in hospital (40 days) and in ICU (18) and a higher 90-day mortality (59%).

About Methotrexate Toxicity:

Methotrexate is a potent anticancer agent used in high doses (>500 mg/m2) to treat osteosarcoma, non-Hodgkin lymphoma, CNS lymphoma, and adult and paediatric acute lymphoblastic leukemia. Because methotrexate is primarily cleared by the kidneys, high doses can induce kidney dysfunction and delayed methotrexate elimination. Exposure to elevated concentrations of methotrexate for minutes to hours may lead to acute renal toxicity and other serious systemic adverse reactions. Early treatment with Voraxaze® is associated with significantly lower rates of toxicity and mortality.i

About Voraxaze:

Acute kidney injury due to high‐dose methotrexate (HDMTX) is a serious, life‐threatening toxicity that can occur in pediatric and adult patients. Voraxaze® (glucarpidase) is a treatment approved by the Food and Drug Administration for high methotrexate concentrations in the context of kidney dysfunction. In clinical studies, patients treated with Voraxaze® experience rapid and sustained reductions in plasma MTX concentrations.ii, iii

About BTG Pharmaceuticals.

BTG Pharmaceuticals provides antidotes that counteract the potentially life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom there are limited or no existing treatment options. We are dedicated to delivering quality medicines that make a real difference to patients through the development, manufacture, and commercialisation of pharmaceutical products. To learn more about BTG Pharmaceuticals, please visit: btgplc.com/pharmaceuticals.

For further information contact:

Chris Sampson, Corporate Communications Director

+44 (0)20 7575 1595; Mobile: +44 (0)7773 251 178

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iVoraxaze® [prescribing information]. BTG International Inc; 2013.

iiWidemann BC, Balis FM, Kim A, et al. Glucarpidase, leucovorin, and thymidine for high-dose methotrexate-induced renal dysfunction: clinical and pharmacologic factors affecting outcome. J Clin Oncol. 2010; 28:3979-3986.

iii2013 Annual Meeting of the North American Congress of Clinical Toxicology (NACCT), Clinical Toxicology 2013; 51(7):575-724. doi:10.3109/15563650.2013.817658.