Interferon beta-1a biosimilar(Biocad Medical, Inc.)

The current COVID-19 pandemic was an exceptional health situation, including for drug use. As there was no known effective drug for COVID-19 at the beginning of the pandemic, different drug candidates were proposed. In this article, we present the challenges for an academic Safety Department to manage the global safety of a European trial during the pandemic. The National Institute for Health and Medical Research (Inserm) conducted a European multicenter, open-label, randomized, controlled trial involving three repurposed and one-in development drugs (lopinavir/ritonavir, IFN-β1a, hydroxychloroquine, and remdesivir) in adults hospitalized with COVID-19. From 25 March 2020 to 29 May 2020, the Inserm Safety Department had to manage 585 Serious Adverse Events (SAEs) initial notification and 396 follow-up reports. The Inserm Safety Department's staff was mobilized to manage these SAEs and to report Expedited safety reports to the competent authorities within the legal timeframes. More than 500 queries were sent to the investigators due to a lack of or incoherent information on SAE forms. At the same time, the investigators were overwhelmed by the management of patients suffering from COVID-19 infection. These particular conditions of missing data and lack of accurate description of adverse events made evaluation of the SAEs very difficult, particularly the assessment of the causal role of each investigational medicinal product. In parallel, working difficulties were accentuated by the national lockdown, frequent IT tool dysfunctions, delayed implementation of monitoring and the absence of automatic alerts for SAE form modification. Although COVID-19 is a confounding factor per se, the delay in and quality of SAE form completion and the real-time medical analysis by the Inserm Safety Department were major issues in the quick identification of potential safety signals. To conduct a high-quality clinical trial and ensure patient safety, all stakeholders must take their roles and responsibilities.

There is increasing evidence of Epstein-Barr virus (EBV) being conditional in multiple sclerosis (MS) pathogenesis and influential for disease activity. Interferon-beta (IFNβ) is a cytokine with antiviral effects used to treat MS, in which a possible antiviral effect against EBV has been questioned. In this study, we investigated the effect of IFNβ-1a treatment on serum EBV antibody levels in 84 patients with relapsing-remitting MS. In the 18 months following IFNβ-1a treatment initiation, there were no significant associations between treatment and serum levels of Epstein-Barr nuclear antigen 1 (EBNA-1) immunoglobulin (Ig) G, early antigen (EA) IgG, viral capsid antigen (VCA) IgG or VCA IgM. The findings suggest that IFNβ-1a treatment does not influence the humoral response to EBV in patients with MS.