One of the objectives of the REALYSA study is to get a better understanding of the profile of adult patients diagnosed with different lymphomas in France, their care pathway, the treatments they receive and their response to treatments. Real world data, collected during routine clinical practice, as in the REALYSA study, are not widely available in France and will be useful to all the stakeholders involved in the care of patients with lymphoma, ultimately for the benefit of patients.
Brentuximab Vedotin (Adcetris®) is a monoclonal anti-CD30 antibody combined with a cytotoxic molecule commercialised by TAKEDA.
Adcetris® is sometimes used as a second-line treatment, in combination with chemotherapy, for the management of certain patients with Hodgkin’s lymphoma who failed first-line treatment, in preparation for an autologous stem cell transplant. In 2020, Adcetris® has been granted an early access authorization (RTU) for this indication (via the French Recommandation Temporaire d’Utilisation Scheme) by the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé, the French Agency supervising the safety of medicines and other health products) to monitor the use and safety of this medicine in this indication.
During the early access period (from 2021 until 2023), data on the use of Adcetris® in this indication must be shared with the ANSM. In order to meet their requirements, TAKEDA was interested to get a descriptive report presenting the profile of the patients included in REALYSA who received Adcetris® in this indication, as well as the response to treatment.
TAKEDA will receive three annual descriptive reports in which the results will be aggregated and anonymised. The company will not receive any individual data.
To all patients participating in REALYSA, and more particularly for patients with Hodgkin’s lymphoma: if you wish to object to the use of your data for this analysis, you can contact your doctor at the care centre who invited you to take part in REALYSA or make a request at dpo@lysarc.org, as described in the Patient Information Leaflet you received at the beginning of your participation in the study. You can find in this document all the information on your rights regarding your personal data. The first data extraction, for the 2022 report, is scheduled for March 4th 2022.