Patient Preferences for Rituximab Additional Risk Minimization Measures: Results From an International Online Survey.

Abstract

ObjectivePatients’ opinions are essential in optimizing risk minimization measures (RMMs) because they bring their real-life experience of disease management and medicines’ use into the regulatory assessments. The aim of the survey launched in 2018 by the European Medicines Agency, in collaboration with the Pharmacovigilance Risk Assessment Committee, was to consult targeted patient groups treated with rituximab for nononcology indications to evaluate their preferences on how to receive information on progressive multifocal leukoencephalopathy and (serious) infections. Additional RMMs such as educational materials for physicians and patients including a patient alert card (PAC) and a patient brochure (PB) are in place to minimize these risks.MethodsA question-based online survey in English created on the EU-Survey platform and disseminated primarily via relevant European patient organizations.ResultsMost patients (47 of 61) had knowledge of these potential adverse effects. Mostly, they were informed by a healthcare professional. Both a PAC and a PB were supported as useful tools to raise awareness of these adverse effects and thus minimize the potential risks among patients. Where the participants had to choose only 1 of these educational materials, 43 of them preferred a PAC, a shorted description that is always held by the patient and reaches the relevant healthcare professional when needed.ConclusionsCollecting patients’ preferences supports periodic assessment of additional RMMs and increase transparency of regulatory processes. Considering the limitations of this initial survey, further investigation is needed to generalize the results into patients’ safety outcomes.