Copenhagen – 1 December 2021 – The first evidence of high dose methotrexate related toxicity (HDMTX) in Spain was presented today at Virtual ISPOR Europe 2021, a global conference on healthcare economics and outcomes. Xavier Badia, MD, MPH, PhD of Omakase Consulting S.L. presented the poster titled “Epidemiology and Clinical Management of Patients with Methotrexate Toxicity in Spain Using the Delphi Technique,” which shows that 11.6% of patients in Spain treated with HDMTX can be expected to develop acute kidney injury, with mortality estimated in 4.2% of cases. These results are the first evidence of HDMTX-related toxicity in Spain, and they are in line with results of previous studies from other countries in which incidence ranges from 2-12% and mortality between 4-6%.
An abstract is available here. Additional authors include Luis Gros, MD, Paediatric Oncology and Haematology Department, Hospital Universitario Vall d’Hebron in Barcelona; Alicia Roldan Perez, MD, Section of Haematology and Haemotherapy, Hospital Universitario Infanta Sofia in Madrid, and Ariadna Giro, PhD, Omakase Consulting S.L.
These results will support BTG Speciality Pharmaceutical’s application for marketing approval for glucarpidase in the European Union, which was submitted to the European Medicines Agency in August of 2020.
Glucarpidase is a carboxypeptidase indicated to reduce toxic methotrexate concentration in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function. BTG sells glucarpidase in the United States as Voraxaze®.
Eva Gallardo, Medical Director at BTG Specialty Pharmaceuticals, said: “This study provides further validation of the acute need for reliable rescue therapy for toxic methotrexate concentration in patients with delayed clearance due to impaired renal function. As we advance our clinical program supporting glucarpidase globally, we are excited to see rigorous consensus results that advance our understanding of the efficacy and value of glucarpidase in appropriate patients.”
High dose MTX chemotherapy is used to treat or prevent the recurrence of certain types of cancer in both adults and children, such as leukaemia, lymphoma, and osteosarcoma. In Spain, 1,475 patients are treated annually with HDMTX. In the hospitals where Voraxaze® is available, 63% of patients would be medically eligible to receive it.
Consensus was reached with the Delphi technique to estimate the incidence and clinical management of patients receiving HDMTX as part of their chemotherapy treatment who develop methotrexate toxicity due to delayed methotrexate elimination. Medical experts on the haemato-oncology and paediatric oncology field directly involved in the management of HDMTX treated patients were selected from leading Spanish hospitals and from hospitals experienced in the use of glucarpidase. Two-round Delphi study using online questionnaire was performed to reach consensus. The questionnaire was developed based on national and international clinical guidelines and published evidence on HDMTX-related toxicity.
About BTG Specialty Pharmaceuticals.
BTG is a growing specialty pharmaceutical platform and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.
Learn more about BTG Specialty Pharmaceuticals: https://btgsp.com
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